Trial Outcomes & Findings for Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment (NCT NCT01235949)
NCT ID: NCT01235949
Last Updated: 2019-05-10
Results Overview
Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
850 participants
Primary outcome timeframe
One month after primary immunization (At Month 3)
Results posted on
2019-05-10
Participant Flow
Among the 850 subjects enrolled in the study, 35 subjects were excluded for lack of confidence in the integrity of the data and 3 subjects were allocated with subject number but didn't receive any vaccination.
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
IIBU Group
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Primary Phase
STARTED
|
198
|
198
|
199
|
71
|
72
|
74
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Primary Phase
COMPLETED
|
194
|
195
|
196
|
69
|
71
|
67
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Primary Phase
NOT COMPLETED
|
4
|
3
|
3
|
2
|
1
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Booster Phase
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
64
|
60
|
63
|
63
|
63
|
63
|
63
|
65
|
62
|
67
|
68
|
67
|
|
Booster Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
64
|
59
|
61
|
62
|
61
|
60
|
60
|
65
|
60
|
66
|
68
|
65
|
|
Booster Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
2
|
3
|
3
|
0
|
2
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
IIBU Group
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Primary Phase
Migrated/moved from study area
|
1
|
1
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Primary Phase
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Primary Phase
Withdrawal by Subject
|
3
|
2
|
2
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Primary Phase
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Booster Phase
Migrated/moved from study area
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Booster Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Booster Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
1
|
2
|
0
|
2
|
0
|
0
|
0
|
|
Booster Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
This baseline measure refers only to the primary phase groups.
Baseline characteristics by cohort
| Measure |
IIBU Group
n=198 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=198 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=199 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=71 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=72 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=74 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IIBU-IIBU Group
n=64 Participants
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU-DIBU Group
n=60 Participants
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU-NIBU Group
n=63 Participants
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-IIBU Group
n=63 Participants
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-DIBU Group
n=63 Participants
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-NIBU Group
n=63 Participants
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-IIBU Group
n=63 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=65 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=62 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IPARA-NPARA Group
n=67 Participants
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=68 Participants
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=67 Participants
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
Total
n=1580 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
13.1 Weeks
STANDARD_DEVIATION 1.15 • n=198 Participants • This baseline measure refers only to the primary phase groups.
|
13 Weeks
STANDARD_DEVIATION 1.2 • n=198 Participants • This baseline measure refers only to the primary phase groups.
|
12.9 Weeks
STANDARD_DEVIATION 1.14 • n=199 Participants • This baseline measure refers only to the primary phase groups.
|
13 Weeks
STANDARD_DEVIATION 1.3 • n=71 Participants • This baseline measure refers only to the primary phase groups.
|
13.2 Weeks
STANDARD_DEVIATION 1.3 • n=72 Participants • This baseline measure refers only to the primary phase groups.
|
13.2 Weeks
STANDARD_DEVIATION 1.11 • n=74 Participants • This baseline measure refers only to the primary phase groups.
|
12.3 Months
STANDARD_DEVIATION 0.64 • n=64 Participants • This baseline measure refers only to the booster phase groups.
|
12.2 Months
STANDARD_DEVIATION 0.49 • n=60 Participants • This baseline measure refers only to the booster phase groups.
|
12.3 Months
STANDARD_DEVIATION 0.57 • n=63 Participants • This baseline measure refers only to the booster phase groups.
|
12.2 Months
STANDARD_DEVIATION 0.45 • n=63 Participants • This baseline measure refers only to the booster phase groups.
|
12.4 Months
STANDARD_DEVIATION 0.63 • n=63 Participants • This baseline measure refers only to the booster phase groups.
|
12.4 Months
STANDARD_DEVIATION 0.73 • n=63 Participants • This baseline measure refers only to the booster phase groups.
|
12.3 Months
STANDARD_DEVIATION 0.63 • n=63 Participants • This baseline measure refers only to the booster phase groups.
|
12.3 Months
STANDARD_DEVIATION 0.57 • n=65 Participants • This baseline measure refers only to the booster phase groups.
|
12.3 Months
STANDARD_DEVIATION 0.70 • n=62 Participants • This baseline measure refers only to the booster phase groups.
|
12.3 Months
STANDARD_DEVIATION 0.73 • n=67 Participants • This baseline measure refers only to the booster phase groups.
|
12.3 Months
STANDARD_DEVIATION 0.56 • n=68 Participants • This baseline measure refers only to the booster phase groups.
|
12.4 Months
STANDARD_DEVIATION 0.63 • n=67 Participants • This baseline measure refers only to the booster phase groups.
|
12.3 Months
STANDARD_DEVIATION 0.61 • n=768 Participants • This baseline measure refers only to the booster phase groups.
|
|
Sex: Female, Male
Female
|
90 Participants
n=198 Participants • This baseline measure refers only to the primary phase groups.
|
86 Participants
n=198 Participants • This baseline measure refers only to the primary phase groups.
|
104 Participants
n=199 Participants • This baseline measure refers only to the primary phase groups.
|
39 Participants
n=71 Participants • This baseline measure refers only to the primary phase groups.
|
40 Participants
n=72 Participants • This baseline measure refers only to the primary phase groups.
|
38 Participants
n=74 Participants • This baseline measure refers only to the primary phase groups.
|
29 Participants
n=64 Participants • This baseline measure refers only to the booster phase groups.
|
27 Participants
n=60 Participants • This baseline measure refers only to the booster phase groups.
|
29 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
23 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
33 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
27 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
32 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
35 Participants
n=65 Participants • This baseline measure refers only to the booster phase groups.
|
35 Participants
n=62 Participants • This baseline measure refers only to the booster phase groups.
|
37 Participants
n=67 Participants • This baseline measure refers only to the booster phase groups.
|
39 Participants
n=68 Participants • This baseline measure refers only to the booster phase groups.
|
33 Participants
n=67 Participants • This baseline measure refers only to the booster phase groups.
|
379 Participants
n=768 Participants • This baseline measure refers only to the booster phase groups.
|
|
Sex: Female, Male
Male
|
108 Participants
n=198 Participants • This baseline measure refers only to the primary phase groups.
|
112 Participants
n=198 Participants • This baseline measure refers only to the primary phase groups.
|
95 Participants
n=199 Participants • This baseline measure refers only to the primary phase groups.
|
32 Participants
n=71 Participants • This baseline measure refers only to the primary phase groups.
|
32 Participants
n=72 Participants • This baseline measure refers only to the primary phase groups.
|
36 Participants
n=74 Participants • This baseline measure refers only to the primary phase groups.
|
35 Participants
n=64 Participants • This baseline measure refers only to the booster phase groups.
|
33 Participants
n=60 Participants • This baseline measure refers only to the booster phase groups.
|
34 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
40 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
30 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
36 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
31 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
30 Participants
n=65 Participants • This baseline measure refers only to the booster phase groups.
|
27 Participants
n=62 Participants • This baseline measure refers only to the booster phase groups.
|
30 Participants
n=67 Participants • This baseline measure refers only to the booster phase groups.
|
29 Participants
n=68 Participants • This baseline measure refers only to the booster phase groups.
|
34 Participants
n=67 Participants • This baseline measure refers only to the booster phase groups.
|
389 Participants
n=768 Participants • This baseline measure refers only to the booster phase groups.
|
|
Race/Ethnicity, Customized
White- Caucasian/European heritage
|
198 Participants
n=198 Participants • This baseline measure refers only to the primary phase groups.
|
197 Participants
n=198 Participants • This baseline measure refers only to the primary phase groups.
|
198 Participants
n=199 Participants • This baseline measure refers only to the primary phase groups.
|
70 Participants
n=71 Participants • This baseline measure refers only to the primary phase groups.
|
72 Participants
n=72 Participants • This baseline measure refers only to the primary phase groups.
|
72 Participants
n=74 Participants • This baseline measure refers only to the primary phase groups.
|
64 Participants
n=64 Participants • This baseline measure refers only to the booster phase groups.
|
60 Participants
n=60 Participants • This baseline measure refers only to the booster phase groups.
|
63 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
63 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
63 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
62 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
63 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
65 Participants
n=65 Participants • This baseline measure refers only to the booster phase groups.
|
62 Participants
n=62 Participants • This baseline measure refers only to the booster phase groups.
|
66 Participants
n=67 Participants • This baseline measure refers only to the booster phase groups.
|
68 Participants
n=68 Participants • This baseline measure refers only to the booster phase groups.
|
66 Participants
n=67 Participants • This baseline measure refers only to the booster phase groups.
|
765 Participants
n=768 Participants • This baseline measure refers only to the booster phase groups.
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
0 Participants
n=198 Participants • This baseline measure refers only to the primary phase groups.
|
0 Participants
n=198 Participants • This baseline measure refers only to the primary phase groups.
|
0 Participants
n=199 Participants • This baseline measure refers only to the primary phase groups.
|
1 Participants
n=71 Participants • This baseline measure refers only to the primary phase groups.
|
0 Participants
n=72 Participants • This baseline measure refers only to the primary phase groups.
|
1 Participants
n=74 Participants • This baseline measure refers only to the primary phase groups.
|
0 Participants
n=64 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=60 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=65 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=62 Participants • This baseline measure refers only to the booster phase groups.
|
1 Participants
n=67 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=68 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=67 Participants • This baseline measure refers only to the booster phase groups.
|
1 Participants
n=768 Participants • This baseline measure refers only to the booster phase groups.
|
|
Race/Ethnicity, Customized
Not specified
|
0 Participants
n=198 Participants • This baseline measure refers only to the primary phase groups.
|
1 Participants
n=198 Participants • This baseline measure refers only to the primary phase groups.
|
1 Participants
n=199 Participants • This baseline measure refers only to the primary phase groups.
|
0 Participants
n=71 Participants • This baseline measure refers only to the primary phase groups.
|
0 Participants
n=72 Participants • This baseline measure refers only to the primary phase groups.
|
1 Participants
n=74 Participants • This baseline measure refers only to the primary phase groups.
|
0 Participants
n=64 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=60 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
1 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=63 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=65 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=62 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=67 Participants • This baseline measure refers only to the booster phase groups.
|
0 Participants
n=68 Participants • This baseline measure refers only to the booster phase groups.
|
1 Participants
n=67 Participants • This baseline measure refers only to the booster phase groups.
|
2 Participants
n=768 Participants • This baseline measure refers only to the booster phase groups.
|
PRIMARY outcome
Timeframe: One month after primary immunization (At Month 3)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=154 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=158 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=164 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=55 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=55 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=56 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Anti-1
|
—
|
—
|
—
|
144 Participants
|
155 Participants
|
160 Participants
|
52 Participants
|
50 Participants
|
55 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Anti-4
|
—
|
—
|
—
|
145 Participants
|
155 Participants
|
158 Participants
|
53 Participants
|
51 Participants
|
56 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Anti-5
|
—
|
—
|
—
|
143 Participants
|
154 Participants
|
156 Participants
|
53 Participants
|
50 Participants
|
54 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Anti-6B
|
—
|
—
|
—
|
121 Participants
|
135 Participants
|
133 Participants
|
42 Participants
|
37 Participants
|
48 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Anti-7F
|
—
|
—
|
—
|
153 Participants
|
157 Participants
|
164 Participants
|
55 Participants
|
55 Participants
|
56 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Anti-9V
|
—
|
—
|
—
|
144 Participants
|
153 Participants
|
155 Participants
|
53 Participants
|
50 Participants
|
53 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Anti-14
|
—
|
—
|
—
|
144 Participants
|
153 Participants
|
154 Participants
|
53 Participants
|
50 Participants
|
53 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Anti-18C
|
—
|
—
|
—
|
143 Participants
|
153 Participants
|
155 Participants
|
52 Participants
|
50 Participants
|
54 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Anti-19F
|
—
|
—
|
—
|
145 Participants
|
152 Participants
|
157 Participants
|
53 Participants
|
50 Participants
|
54 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Anti-23F
|
—
|
—
|
—
|
136 Participants
|
141 Participants
|
149 Participants
|
47 Participants
|
43 Participants
|
50 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after primary immunization (At Month 3)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=154 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=158 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=164 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=55 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=55 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=56 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-1
|
—
|
—
|
—
|
1.82 µg/mL
Interval 1.59 to 2.09
|
1.71 µg/mL
Interval 1.49 to 1.95
|
1.9 µg/mL
Interval 1.67 to 2.17
|
1.32 µg/mL
Interval 1.04 to 1.67
|
1.38 µg/mL
Interval 1.09 to 1.74
|
1.95 µg/mL
Interval 1.64 to 2.32
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-4
|
—
|
—
|
—
|
2.25 µg/mL
Interval 1.97 to 2.57
|
2.21 µg/mL
Interval 1.95 to 2.51
|
2.21 µg/mL
Interval 1.96 to 2.5
|
1.57 µg/mL
Interval 1.21 to 2.04
|
1.95 µg/mL
Interval 1.63 to 2.32
|
2.59 µg/mL
Interval 2.07 to 3.24
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-5
|
—
|
—
|
—
|
2.93 µg/mL
Interval 2.58 to 3.33
|
2.39 µg/mL
Interval 2.13 to 2.69
|
2.77 µg/mL
Interval 2.44 to 3.15
|
1.95 µg/mL
Interval 1.53 to 2.48
|
2.36 µg/mL
Interval 1.89 to 2.94
|
3.05 µg/mL
Interval 2.53 to 3.68
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-6B
|
—
|
—
|
—
|
0.67 µg/mL
Interval 0.55 to 0.81
|
0.76 µg/mL
Interval 0.63 to 0.92
|
0.6 µg/mL
Interval 0.49 to 0.72
|
0.49 µg/mL
Interval 0.34 to 0.69
|
0.42 µg/mL
Interval 0.28 to 0.62
|
0.72 µg/mL
Interval 0.51 to 1.02
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-7F
|
—
|
—
|
—
|
2.87 µg/mL
Interval 2.52 to 3.27
|
2.83 µg/mL
Interval 2.52 to 3.17
|
2.77 µg/mL
Interval 2.49 to 3.09
|
2.18 µg/mL
Interval 1.75 to 2.7
|
2.45 µg/mL
Interval 2.01 to 2.99
|
2.95 µg/mL
Interval 2.37 to 3.69
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-9V
|
—
|
—
|
—
|
2.1 µg/mL
Interval 1.81 to 2.42
|
2.01 µg/mL
Interval 1.79 to 2.27
|
2.18 µg/mL
Interval 1.91 to 2.5
|
1.67 µg/mL
Interval 1.3 to 2.13
|
1.82 µg/mL
Interval 1.48 to 2.23
|
2.4 µg/mL
Interval 1.87 to 3.1
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-14
|
—
|
—
|
—
|
4.76 µg/mL
Interval 4.1 to 5.51
|
4.52 µg/mL
Interval 3.91 to 5.21
|
4.77 µg/mL
Interval 4.08 to 5.58
|
3.44 µg/mL
Interval 2.55 to 4.62
|
4.12 µg/mL
Interval 3.21 to 5.29
|
5.17 µg/mL
Interval 4.2 to 6.36
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-18C
|
—
|
—
|
—
|
3.85 µg/mL
Interval 3.23 to 4.6
|
3.8 µg/mL
Interval 3.24 to 4.46
|
4.34 µg/mL
Interval 3.65 to 5.15
|
3.08 µg/mL
Interval 2.29 to 4.15
|
4.08 µg/mL
Interval 3.15 to 5.29
|
4.96 µg/mL
Interval 3.75 to 6.55
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-19F
|
—
|
—
|
—
|
6.11 µg/mL
Interval 5.26 to 7.1
|
5.04 µg/mL
Interval 4.35 to 5.86
|
4.96 µg/mL
Interval 4.22 to 5.83
|
4.95 µg/mL
Interval 3.74 to 6.54
|
5.2 µg/mL
Interval 3.94 to 6.85
|
6.98 µg/mL
Interval 5.48 to 8.88
|
—
|
—
|
—
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-23F
|
—
|
—
|
—
|
1.04 µg/mL
Interval 0.86 to 1.26
|
0.92 µg/mL
Interval 0.76 to 1.11
|
1.07 µg/mL
Interval 0.91 to 1.26
|
0.77 µg/mL
Interval 0.54 to 1.09
|
0.74 µg/mL
Interval 0.51 to 1.08
|
1 µg/mL
Interval 0.73 to 1.36
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after primary immunization (At Month 3)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=150 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=158 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=164 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=54 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=53 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=54 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Protein D (Anti-PD)
|
—
|
—
|
—
|
1461.3 EL.U/mL
Interval 1267.4 to 1684.8
|
1353.1 EL.U/mL
Interval 1191.3 to 1537.0
|
1557.7 EL.U/mL
Interval 1355.4 to 1790.3
|
1109.6 EL.U/mL
Interval 876.9 to 1404.1
|
1348.6 EL.U/mL
Interval 1048.2 to 1734.9
|
1667.9 EL.U/mL
Interval 1401.9 to 1984.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after primary immunization (At Month 3)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=147 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=152 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=157 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=53 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=50 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=53 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Anti-6A
|
—
|
—
|
—
|
0.17 μg/mL
Interval 0.14 to 0.21
|
0.18 μg/mL
Interval 0.15 to 0.23
|
0.15 μg/mL
Interval 0.12 to 0.19
|
0.11 μg/mL
Interval 0.08 to 0.16
|
0.12 μg/mL
Interval 0.08 to 0.17
|
0.19 μg/mL
Interval 0.13 to 0.27
|
—
|
—
|
—
|
|
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Anti-19A
|
—
|
—
|
—
|
0.23 μg/mL
Interval 0.18 to 0.28
|
0.2 μg/mL
Interval 0.16 to 0.25
|
0.16 μg/mL
Interval 0.13 to 0.19
|
0.15 μg/mL
Interval 0.11 to 0.22
|
0.17 μg/mL
Interval 0.12 to 0.25
|
0.25 μg/mL
Interval 0.17 to 0.36
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.
Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=197 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=197 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=199 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=70 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=71 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=74 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
—
|
—
|
—
|
44 Participants
|
48 Participants
|
78 Participants
|
21 Participants
|
28 Participants
|
33 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
—
|
—
|
—
|
3 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
—
|
—
|
—
|
74 Participants
|
52 Participants
|
77 Participants
|
24 Participants
|
19 Participants
|
32 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
—
|
—
|
—
|
29 Participants
|
22 Participants
|
28 Participants
|
10 Participants
|
7 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
—
|
—
|
—
|
60 Participants
|
49 Participants
|
67 Participants
|
19 Participants
|
22 Participants
|
25 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
—
|
—
|
—
|
1 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
—
|
—
|
—
|
73 Participants
|
59 Participants
|
72 Participants
|
24 Participants
|
23 Participants
|
31 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
—
|
—
|
—
|
31 Participants
|
33 Participants
|
31 Participants
|
10 Participants
|
11 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3
|
—
|
—
|
—
|
50 Participants
|
48 Participants
|
52 Participants
|
18 Participants
|
21 Participants
|
22 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
—
|
—
|
—
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 3
|
—
|
—
|
—
|
70 Participants
|
63 Participants
|
56 Participants
|
28 Participants
|
25 Participants
|
27 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3
|
—
|
—
|
—
|
36 Participants
|
32 Participants
|
30 Participants
|
16 Participants
|
12 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses
|
—
|
—
|
—
|
92 Participants
|
76 Participants
|
107 Participants
|
30 Participants
|
37 Participants
|
44 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
|
—
|
—
|
—
|
5 Participants
|
7 Participants
|
15 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across doses
|
—
|
—
|
—
|
108 Participants
|
89 Participants
|
105 Participants
|
36 Participants
|
35 Participants
|
46 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across doses
|
—
|
—
|
—
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses
|
—
|
—
|
—
|
61 Participants
|
51 Participants
|
57 Participants
|
20 Participants
|
17 Participants
|
19 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
—
|
—
|
—
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 4-day (Days 0-3) period following booster vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.
Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).
Outcome measures
| Measure |
IPARA-NPARA Group
n=66 Participants
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=67 Participants
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=64 Participants
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=63 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=59 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=59 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=60 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=61 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=59 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
n=60 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=63 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=61 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain
|
23 Participants
|
24 Participants
|
24 Participants
|
25 Participants
|
22 Participants
|
15 Participants
|
22 Participants
|
16 Participants
|
25 Participants
|
28 Participants
|
32 Participants
|
28 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
4 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness
|
23 Participants
|
23 Participants
|
23 Participants
|
27 Participants
|
25 Participants
|
17 Participants
|
23 Participants
|
15 Participants
|
22 Participants
|
23 Participants
|
25 Participants
|
23 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
17 Participants
|
12 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
9 Participants
|
16 Participants
|
6 Participants
|
11 Participants
|
16 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.
Solicited general symptoms included drowsiness, irritability, loss of appetite and fever \[rectally, greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (\>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=197 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=197 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=199 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=70 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=71 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=74 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 1
|
—
|
—
|
—
|
71 Participants
|
78 Participants
|
101 Participants
|
33 Participants
|
28 Participants
|
36 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 1
|
—
|
—
|
—
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 1
|
—
|
—
|
—
|
42 Participants
|
47 Participants
|
65 Participants
|
20 Participants
|
17 Participants
|
24 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 1
|
—
|
—
|
—
|
91 Participants
|
83 Participants
|
109 Participants
|
27 Participants
|
34 Participants
|
43 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 1
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 1
|
—
|
—
|
—
|
61 Participants
|
49 Participants
|
76 Participants
|
18 Participants
|
16 Participants
|
27 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss appetite, Dose 1
|
—
|
—
|
—
|
51 Participants
|
54 Participants
|
71 Participants
|
11 Participants
|
19 Participants
|
32 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss appetite, Dose 1
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss appetite, Dose 1
|
—
|
—
|
—
|
32 Participants
|
35 Participants
|
43 Participants
|
8 Participants
|
11 Participants
|
20 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 1
|
—
|
—
|
—
|
81 Participants
|
73 Participants
|
85 Participants
|
8 Participants
|
11 Participants
|
30 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 1
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 1
|
—
|
—
|
—
|
58 Participants
|
56 Participants
|
68 Participants
|
6 Participants
|
8 Participants
|
23 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 2
|
—
|
—
|
—
|
64 Participants
|
66 Participants
|
63 Participants
|
28 Participants
|
15 Participants
|
25 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 2
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 2
|
—
|
—
|
—
|
40 Participants
|
41 Participants
|
43 Participants
|
16 Participants
|
12 Participants
|
15 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 2
|
—
|
—
|
—
|
79 Participants
|
88 Participants
|
89 Participants
|
30 Participants
|
31 Participants
|
37 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 2
|
—
|
—
|
—
|
3 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 2
|
—
|
—
|
—
|
56 Participants
|
58 Participants
|
64 Participants
|
20 Participants
|
22 Participants
|
25 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss appetite, Dose 2
|
—
|
—
|
—
|
52 Participants
|
55 Participants
|
47 Participants
|
12 Participants
|
11 Participants
|
22 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss appetite, Dose 2
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss appetite, Dose 2
|
—
|
—
|
—
|
37 Participants
|
41 Participants
|
28 Participants
|
7 Participants
|
8 Participants
|
14 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 2
|
—
|
—
|
—
|
76 Participants
|
55 Participants
|
69 Participants
|
14 Participants
|
15 Participants
|
24 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 2
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 2
|
—
|
—
|
—
|
61 Participants
|
49 Participants
|
55 Participants
|
11 Participants
|
10 Participants
|
19 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 3
|
—
|
—
|
—
|
62 Participants
|
50 Participants
|
45 Participants
|
18 Participants
|
8 Participants
|
16 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 3
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 3
|
—
|
—
|
—
|
40 Participants
|
35 Participants
|
30 Participants
|
12 Participants
|
5 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 3
|
—
|
—
|
—
|
74 Participants
|
68 Participants
|
77 Participants
|
17 Participants
|
21 Participants
|
29 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 3
|
—
|
—
|
—
|
3 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Across doses
|
—
|
—
|
—
|
86 Participants
|
82 Participants
|
104 Participants
|
28 Participants
|
28 Participants
|
40 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 3
|
—
|
—
|
—
|
48 Participants
|
48 Participants
|
57 Participants
|
10 Participants
|
12 Participants
|
17 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss appetite, Dose 3
|
—
|
—
|
—
|
42 Participants
|
41 Participants
|
42 Participants
|
9 Participants
|
9 Participants
|
16 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss appetite, Across doses
|
—
|
—
|
—
|
84 Participants
|
98 Participants
|
100 Participants
|
24 Participants
|
24 Participants
|
42 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss appetite, Dose 3
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss appetite, Dose 3
|
—
|
—
|
—
|
26 Participants
|
30 Participants
|
26 Participants
|
5 Participants
|
7 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 3
|
—
|
—
|
—
|
46 Participants
|
31 Participants
|
42 Participants
|
12 Participants
|
7 Participants
|
14 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 3
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 3
|
—
|
—
|
—
|
38 Participants
|
27 Participants
|
35 Participants
|
7 Participants
|
5 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Across doses
|
—
|
—
|
—
|
115 Participants
|
111 Participants
|
123 Participants
|
40 Participants
|
33 Participants
|
45 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Across doses
|
—
|
—
|
—
|
6 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Across doses
|
—
|
—
|
—
|
77 Participants
|
72 Participants
|
87 Participants
|
26 Participants
|
22 Participants
|
32 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Across doses
|
—
|
—
|
—
|
120 Participants
|
121 Participants
|
138 Participants
|
40 Participants
|
43 Participants
|
59 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Across doses
|
—
|
—
|
—
|
10 Participants
|
12 Participants
|
12 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss appetite, Across doses
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss appetite, Across doses
|
—
|
—
|
—
|
56 Participants
|
68 Participants
|
64 Participants
|
16 Participants
|
16 Participants
|
30 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Across doses
|
—
|
—
|
—
|
121 Participants
|
101 Participants
|
122 Participants
|
23 Participants
|
27 Participants
|
40 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Across doses
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Across doses
|
—
|
—
|
—
|
90 Participants
|
84 Participants
|
101 Participants
|
18 Participants
|
18 Participants
|
31 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 4-day (Days 0-3) period following booster vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.
Solicited general symptoms included drowsiness, irritability, loss of appetite and fever \[rectally, greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (\>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
IPARA-NPARA Group
n=66 Participants
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=67 Participants
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=64 Participants
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=63 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=59 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=59 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=60 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=61 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=59 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
n=60 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=63 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=61 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness
|
12 Participants
|
16 Participants
|
19 Participants
|
18 Participants
|
18 Participants
|
17 Participants
|
19 Participants
|
9 Participants
|
21 Participants
|
22 Participants
|
24 Participants
|
24 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness
|
10 Participants
|
13 Participants
|
16 Participants
|
15 Participants
|
13 Participants
|
13 Participants
|
13 Participants
|
9 Participants
|
17 Participants
|
17 Participants
|
18 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability
|
26 Participants
|
22 Participants
|
27 Participants
|
33 Participants
|
27 Participants
|
23 Participants
|
22 Participants
|
26 Participants
|
27 Participants
|
36 Participants
|
33 Participants
|
32 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability
|
18 Participants
|
20 Participants
|
16 Participants
|
22 Participants
|
18 Participants
|
13 Participants
|
13 Participants
|
20 Participants
|
23 Participants
|
27 Participants
|
26 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite
|
9 Participants
|
10 Participants
|
17 Participants
|
14 Participants
|
16 Participants
|
9 Participants
|
12 Participants
|
15 Participants
|
19 Participants
|
21 Participants
|
24 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite
|
8 Participants
|
6 Participants
|
13 Participants
|
11 Participants
|
11 Participants
|
4 Participants
|
9 Participants
|
15 Participants
|
17 Participants
|
19 Participants
|
19 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever
|
21 Participants
|
14 Participants
|
18 Participants
|
22 Participants
|
21 Participants
|
15 Participants
|
19 Participants
|
19 Participants
|
20 Participants
|
20 Participants
|
23 Participants
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
18 Participants
|
13 Participants
|
16 Participants
|
20 Participants
|
17 Participants
|
12 Participants
|
17 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
19 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (Month 0 to 10)Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects who received at least one vaccine dose.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity.
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=198 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=198 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=199 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=71 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=72 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=74 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs)
|
—
|
—
|
—
|
4 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 31-days (Day 0-30) following each primary vaccination dosePopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=198 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=198 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=199 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=71 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=72 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=74 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
—
|
—
|
—
|
28 Participants
|
33 Participants
|
35 Participants
|
16 Participants
|
4 Participants
|
13 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 31-days (Day 0-30) following booster vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Outcome measures
| Measure |
IPARA-NPARA Group
n=67 Participants
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=68 Participants
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=67 Participants
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=64 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=60 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=63 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=63 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=63 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=63 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
n=63 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=65 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=62 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
4 Subjects
|
0 Subjects
|
2 Subjects
|
6 Subjects
|
6 Subjects
|
2 Subjects
|
3 Subjects
|
3 Subjects
|
4 Subjects
|
6 Subjects
|
6 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Anti- pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
n=50 Participants
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=47 Participants
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=48 Participants
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=50 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=46 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=42 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=48 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=48 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=47 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
n=46 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=47 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=46 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-23F M9
|
0.47 μg/mL
Interval 0.34 to 0.65
|
0.43 μg/mL
Interval 0.3 to 0.62
|
0.52 μg/mL
Interval 0.37 to 0.74
|
0.65 μg/mL
Interval 0.45 to 0.94
|
0.64 μg/mL
Interval 0.52 to 0.79
|
0.41 μg/mL
Interval 0.28 to 0.58
|
0.55 μg/mL
Interval 0.39 to 0.77
|
0.5 μg/mL
Interval 0.34 to 0.72
|
0.65 μg/mL
Interval 0.5 to 0.84
|
0.61 μg/mL
Interval 0.45 to 0.81
|
0.69 μg/mL
Interval 0.51 to 0.92
|
0.58 μg/mL
Interval 0.43 to 0.79
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-1, M9
|
0.31 μg/mL
Interval 0.24 to 0.4
|
0.3 μg/mL
Interval 0.23 to 0.4
|
0.45 μg/mL
Interval 0.32 to 0.64
|
0.41 μg/mL
Interval 0.31 to 0.54
|
0.36 μg/mL
Interval 0.28 to 0.46
|
0.27 μg/mL
Interval 0.22 to 0.34
|
0.38 μg/mL
Interval 0.28 to 0.53
|
0.42 μg/mL
Interval 0.31 to 0.57
|
0.34 μg/mL
Interval 0.27 to 0.42
|
0.44 μg/mL
Interval 0.34 to 0.58
|
0.38 μg/mL
Interval 0.3 to 0.48
|
0.43 μg/mL
Interval 0.32 to 0.58
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-1, M10
|
1.76 μg/mL
Interval 1.29 to 2.38
|
2.14 μg/mL
Interval 1.59 to 2.89
|
2.84 μg/mL
Interval 2.06 to 3.89
|
2.87 μg/mL
Interval 2.1 to 3.91
|
2.23 μg/mL
Interval 1.57 to 3.17
|
2.39 μg/mL
Interval 1.68 to 3.41
|
2.69 μg/mL
Interval 1.99 to 3.63
|
2.44 μg/mL
Interval 1.78 to 3.33
|
1.87 μg/mL
Interval 1.36 to 2.57
|
2.84 μg/mL
Interval 2.02 to 3.99
|
3.04 μg/mL
Interval 2.38 to 3.88
|
2.84 μg/mL
Interval 2.1 to 3.85
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-4, M9
|
0.52 μg/mL
Interval 0.39 to 0.68
|
0.6 μg/mL
Interval 0.48 to 0.76
|
0.84 μg/mL
Interval 0.64 to 1.11
|
0.71 μg/mL
Interval 0.55 to 0.92
|
0.63 μg/mL
Interval 0.5 to 0.8
|
0.55 μg/mL
Interval 0.44 to 0.69
|
0.63 μg/mL
Interval 0.47 to 0.85
|
0.72 μg/mL
Interval 0.55 to 0.95
|
0.64 μg/mL
Interval 0.49 to 0.83
|
0.72 μg/mL
Interval 0.55 to 0.93
|
0.73 μg/mL
Interval 0.55 to 0.98
|
0.62 μg/mL
Interval 0.47 to 0.82
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-4, M10
|
3.27 μg/mL
Interval 2.51 to 4.25
|
3.31 μg/mL
Interval 2.66 to 4.12
|
4.28 μg/mL
Interval 3.23 to 5.68
|
4.09 μg/mL
Interval 3.2 to 5.22
|
3.65 μg/mL
Interval 2.76 to 4.84
|
3.22 μg/mL
Interval 2.36 to 4.39
|
4.05 μg/mL
Interval 2.99 to 5.5
|
3.63 μg/mL
Interval 2.84 to 4.62
|
3.41 μg/mL
Interval 2.46 to 4.71
|
4.04 μg/mL
Interval 3.05 to 5.36
|
4.08 μg/mL
Interval 3.11 to 5.36
|
4.07 μg/mL
Interval 3.09 to 5.35
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-5, M9
|
0.59 μg/mL
Interval 0.45 to 0.77
|
0.72 μg/mL
Interval 0.57 to 0.91
|
0.85 μg/mL
Interval 0.62 to 1.17
|
0.98 μg/mL
Interval 0.74 to 1.29
|
0.83 μg/mL
Interval 0.66 to 1.05
|
0.76 μg/mL
Interval 0.59 to 0.98
|
0.78 μg/mL
Interval 0.61 to 1.0
|
0.76 μg/mL
Interval 0.58 to 0.99
|
0.7 μg/mL
Interval 0.57 to 0.86
|
0.83 μg/mL
Interval 0.66 to 1.05
|
0.84 μg/mL
Interval 0.67 to 1.04
|
0.96 μg/mL
Interval 0.76 to 1.23
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-5, M10
|
2.62 μg/mL
Interval 1.92 to 3.57
|
3.58 μg/mL
Interval 2.74 to 4.69
|
4.33 μg/mL
Interval 3.26 to 5.76
|
4.5 μg/mL
Interval 3.45 to 5.88
|
3.9 μg/mL
Interval 2.95 to 5.16
|
4.11 μg/mL
Interval 2.91 to 5.81
|
3.42 μg/mL
Interval 2.62 to 4.46
|
3.33 μg/mL
Interval 2.56 to 4.33
|
3.37 μg/mL
Interval 2.46 to 4.6
|
4.21 μg/mL
Interval 3.03 to 5.86
|
3.92 μg/mL
Interval 3.06 to 5.01
|
4.48 μg/mL
Interval 3.48 to 5.77
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-6B, M9
|
0.43 μg/mL
Interval 0.33 to 0.56
|
0.43 μg/mL
Interval 0.33 to 0.57
|
0.61 μg/mL
Interval 0.49 to 0.76
|
0.63 μg/mL
Interval 0.48 to 0.82
|
0.44 μg/mL
Interval 0.31 to 0.61
|
0.54 μg/mL
Interval 0.4 to 0.72
|
0.55 μg/mL
Interval 0.4 to 0.77
|
0.62 μg/mL
Interval 0.48 to 0.8
|
0.6 μg/mL
Interval 0.45 to 0.8
|
0.56 μg/mL
Interval 0.42 to 0.75
|
0.58 μg/mL
Interval 0.43 to 0.78
|
0.67 μg/mL
Interval 0.51 to 0.87
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-6B M10
|
1.74 μg/mL
Interval 1.23 to 2.45
|
1.84 μg/mL
Interval 1.36 to 2.49
|
2.29 μg/mL
Interval 1.79 to 2.91
|
2.75 μg/mL
Interval 2.16 to 3.48
|
1.97 μg/mL
Interval 1.41 to 2.74
|
2.43 μg/mL
Interval 1.85 to 3.19
|
2.13 μg/mL
Interval 1.64 to 2.76
|
2.18 μg/mL
Interval 1.69 to 2.81
|
1.52 μg/mL
Interval 0.98 to 2.34
|
2.16 μg/mL
Interval 1.47 to 3.18
|
2.32 μg/mL
Interval 1.6 to 3.36
|
2.51 μg/mL
Interval 1.96 to 3.22
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-7F, M9
|
0.84 μg/mL
Interval 0.67 to 1.06
|
0.98 μg/mL
Interval 0.79 to 1.22
|
0.97 μg/mL
Interval 0.76 to 1.24
|
1.33 μg/mL
Interval 1.07 to 1.64
|
0.96 μg/mL
Interval 0.75 to 1.23
|
0.89 μg/mL
Interval 0.74 to 1.07
|
1.08 μg/mL
Interval 0.8 to 1.46
|
1.1 μg/mL
Interval 0.9 to 1.35
|
1.09 μg/mL
Interval 0.89 to 1.34
|
1.07 μg/mL
Interval 0.89 to 1.29
|
1.31 μg/mL
Interval 1.02 to 1.67
|
1.11 μg/mL
Interval 0.83 to 1.49
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-7F M10
|
3.89 μg/mL
Interval 2.98 to 5.1
|
4.63 μg/mL
Interval 3.56 to 6.04
|
4.52 μg/mL
Interval 3.31 to 6.16
|
5.75 μg/mL
Interval 4.59 to 7.21
|
4.2 μg/mL
Interval 3.33 to 5.31
|
4.2 μg/mL
Interval 3.24 to 5.46
|
4.96 μg/mL
Interval 3.77 to 6.54
|
4.36 μg/mL
Interval 3.35 to 5.66
|
3.93 μg/mL
Interval 3.04 to 5.08
|
5.43 μg/mL
Interval 4.13 to 7.14
|
5.55 μg/mL
Interval 4.38 to 7.04
|
4.93 μg/mL
Interval 3.64 to 6.69
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-9V, M9
|
0.74 μg/mL
Interval 0.58 to 0.95
|
0.93 μg/mL
Interval 0.76 to 1.14
|
0.97 μg/mL
Interval 0.73 to 1.28
|
1.07 μg/mL
Interval 0.82 to 1.39
|
0.83 μg/mL
Interval 0.67 to 1.02
|
0.83 μg/mL
Interval 0.67 to 1.03
|
1.03 μg/mL
Interval 0.79 to 1.36
|
1.03 μg/mL
Interval 0.81 to 1.3
|
0.93 μg/mL
Interval 0.76 to 1.14
|
1.09 μg/mL
Interval 0.83 to 1.44
|
0.92 μg/mL
Interval 0.76 to 1.12
|
1.09 μg/mL
Interval 0.82 to 1.46
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-9V M10
|
3.11 μg/mL
Interval 2.36 to 4.09
|
3.49 μg/mL
Interval 2.68 to 4.56
|
3.9 μg/mL
Interval 2.86 to 5.3
|
4.46 μg/mL
Interval 3.35 to 5.93
|
3.3 μg/mL
Interval 2.47 to 4.41
|
3.94 μg/mL
Interval 2.8 to 5.54
|
3.47 μg/mL
Interval 2.76 to 4.36
|
3.16 μg/mL
Interval 2.39 to 4.17
|
3.07 μg/mL
Interval 2.32 to 4.07
|
4.07 μg/mL
Interval 3.0 to 5.52
|
3.88 μg/mL
Interval 3.09 to 4.87
|
4.05 μg/mL
Interval 3.18 to 5.15
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-14, M9
|
1.18 μg/mL
Interval 0.85 to 1.64
|
1.53 μg/mL
Interval 1.08 to 2.16
|
1.86 μg/mL
Interval 1.38 to 2.52
|
1.76 μg/mL
Interval 1.23 to 2.51
|
1.74 μg/mL
Interval 1.25 to 2.41
|
1.06 μg/mL
Interval 0.71 to 1.57
|
1.31 μg/mL
Interval 0.99 to 1.74
|
1.7 μg/mL
Interval 1.18 to 2.44
|
1.73 μg/mL
Interval 1.29 to 2.33
|
1.6 μg/mL
Interval 1.06 to 2.39
|
1.93 μg/mL
Interval 1.47 to 2.53
|
1.95 μg/mL
Interval 1.28 to 2.95
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-14 M10
|
4.72 μg/mL
Interval 3.56 to 6.27
|
5.52 μg/mL
Interval 4.13 to 7.38
|
5.62 μg/mL
Interval 4.23 to 7.48
|
6.02 μg/mL
Interval 4.47 to 8.12
|
5.62 μg/mL
Interval 3.99 to 7.92
|
5.16 μg/mL
Interval 3.61 to 7.36
|
4.54 μg/mL
Interval 3.45 to 5.98
|
5.08 μg/mL
Interval 3.8 to 6.8
|
4.61 μg/mL
Interval 3.37 to 6.3
|
6.03 μg/mL
Interval 4.18 to 8.7
|
6.56 μg/mL
Interval 5.06 to 8.51
|
6.3 μg/mL
Interval 4.45 to 8.92
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-18C M9
|
0.91 μg/mL
Interval 0.67 to 1.23
|
1.14 μg/mL
Interval 0.92 to 1.41
|
1.31 μg/mL
Interval 1.01 to 1.69
|
1.13 μg/mL
Interval 0.88 to 1.47
|
1.03 μg/mL
Interval 0.81 to 1.32
|
0.96 μg/mL
Interval 0.73 to 1.26
|
1.08 μg/mL
Interval 0.82 to 1.41
|
1.1 μg/mL
Interval 0.86 to 1.39
|
1.03 μg/mL
Interval 0.8 to 1.31
|
1.12 μg/mL
Interval 0.87 to 1.43
|
1.39 μg/mL
Interval 1.08 to 1.79
|
1.23 μg/mL
Interval 0.93 to 1.63
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-18C M10
|
6.18 μg/mL
Interval 4.65 to 8.2
|
8.66 μg/mL
Interval 6.76 to 11.09
|
8.17 μg/mL
Interval 5.8 to 11.52
|
9.35 μg/mL
Interval 7.13 to 12.25
|
8.06 μg/mL
Interval 5.93 to 10.96
|
7.78 μg/mL
Interval 5.53 to 10.93
|
8.23 μg/mL
Interval 6.37 to 10.65
|
7.16 μg/mL
Interval 5.41 to 9.46
|
7.1 μg/mL
Interval 5.33 to 9.46
|
7.15 μg/mL
Interval 5.13 to 9.96
|
11.29 μg/mL
Interval 7.96 to 16.0
|
8.68 μg/mL
Interval 6.41 to 11.75
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-19F M9
|
1.56 μg/mL
Interval 1.14 to 2.13
|
1.51 μg/mL
Interval 1.15 to 2.0
|
1.72 μg/mL
Interval 1.31 to 2.27
|
1.94 μg/mL
Interval 1.46 to 2.57
|
1.66 μg/mL
Interval 1.28 to 2.17
|
1.72 μg/mL
Interval 1.23 to 2.39
|
1.58 μg/mL
Interval 1.14 to 2.19
|
1.54 μg/mL
Interval 1.09 to 2.19
|
1.38 μg/mL
Interval 1.09 to 1.75
|
1.25 μg/mL
Interval 0.96 to 1.63
|
1.7 μg/mL
Interval 1.27 to 2.26
|
1.9 μg/mL
Interval 1.38 to 2.62
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-19F M10
|
5.94 μg/mL
Interval 4.43 to 7.97
|
5.54 μg/mL
Interval 3.88 to 7.93
|
6.66 μg/mL
Interval 4.92 to 9.01
|
6.9 μg/mL
Interval 4.89 to 9.72
|
6.64 μg/mL
Interval 5.17 to 8.54
|
6.91 μg/mL
Interval 4.88 to 9.77
|
5.35 μg/mL
Interval 3.84 to 7.47
|
5.27 μg/mL
Interval 3.64 to 7.64
|
5.57 μg/mL
Interval 4.14 to 7.51
|
5.24 μg/mL
Interval 3.66 to 7.49
|
7.26 μg/mL
Interval 5.28 to 9.97
|
7.34 μg/mL
Interval 5.55 to 9.73
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-23F M10
|
2.5 μg/mL
Interval 1.76 to 3.56
|
2.53 μg/mL
Interval 1.74 to 3.68
|
3.15 μg/mL
Interval 2.31 to 4.3
|
3.72 μg/mL
Interval 2.6 to 5.33
|
3.08 μg/mL
Interval 2.25 to 4.21
|
2.59 μg/mL
Interval 1.63 to 4.11
|
2.93 μg/mL
Interval 2.05 to 4.19
|
2.16 μg/mL
Interval 1.4 to 3.33
|
2.74 μg/mL
Interval 2.06 to 3.65
|
3.12 μg/mL
Interval 2.17 to 4.48
|
3.17 μg/mL
Interval 2.34 to 4.31
|
3.33 μg/mL
Interval 2.36 to 4.7
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-6A, M9
|
0.19 μg/mL
Interval 0.13 to 0.27
|
0.22 μg/mL
Interval 0.16 to 0.31
|
0.24 μg/mL
Interval 0.17 to 0.35
|
0.31 μg/mL
Interval 0.21 to 0.46
|
0.18 μg/mL
Interval 0.12 to 0.27
|
0.25 μg/mL
Interval 0.17 to 0.37
|
0.26 μg/mL
Interval 0.18 to 0.39
|
0.32 μg/mL
Interval 0.23 to 0.43
|
0.32 μg/mL
Interval 0.21 to 0.49
|
0.26 μg/mL
Interval 0.17 to 0.4
|
0.28 μg/mL
Interval 0.19 to 0.43
|
0.34 μg/mL
Interval 0.24 to 0.49
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-6A M10
|
0.81 μg/mL
Interval 0.53 to 1.23
|
0.87 μg/mL
Interval 0.59 to 1.29
|
0.98 μg/mL
Interval 0.67 to 1.43
|
1.36 μg/mL
Interval 0.93 to 1.97
|
0.86 μg/mL
Interval 0.56 to 1.34
|
1.14 μg/mL
Interval 0.72 to 1.79
|
0.89 μg/mL
Interval 0.57 to 1.39
|
1.09 μg/mL
Interval 0.78 to 1.54
|
0.74 μg/mL
Interval 0.49 to 1.12
|
1.03 μg/mL
Interval 0.61 to 1.74
|
0.99 μg/mL
Interval 0.66 to 1.48
|
1.4 μg/mL
Interval 0.97 to 2.01
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-19A M9
|
0.21 μg/mL
Interval 0.15 to 0.3
|
0.19 μg/mL
Interval 0.13 to 0.28
|
0.24 μg/mL
Interval 0.16 to 0.36
|
0.28 μg/mL
Interval 0.19 to 0.42
|
0.23 μg/mL
Interval 0.16 to 0.32
|
0.22 μg/mL
Interval 0.15 to 0.32
|
0.24 μg/mL
Interval 0.16 to 0.36
|
0.2 μg/mL
Interval 0.14 to 0.3
|
0.24 μg/mL
Interval 0.17 to 0.33
|
0.15 μg/mL
Interval 0.11 to 0.2
|
0.2 μg/mL
Interval 0.14 to 0.3
|
0.28 μg/mL
Interval 0.19 to 0.4
|
|
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-19A M10
|
0.74 μg/mL
Interval 0.49 to 1.1
|
0.63 μg/mL
Interval 0.37 to 1.09
|
1.11 μg/mL
Interval 0.71 to 1.74
|
1.11 μg/mL
Interval 0.67 to 1.83
|
1.1 μg/mL
Interval 0.78 to 1.56
|
1.05 μg/mL
Interval 0.66 to 1.69
|
0.75 μg/mL
Interval 0.48 to 1.15
|
0.66 μg/mL
Interval 0.4 to 1.1
|
0.95 μg/mL
Interval 0.61 to 1.48
|
0.67 μg/mL
Interval 0.43 to 1.04
|
0.93 μg/mL
Interval 0.58 to 1.47
|
0.97 μg/mL
Interval 0.61 to 1.53
|
SECONDARY outcome
Timeframe: One month after primary immunization (Month 3)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results or antibodies against at least one study vaccine antigen component after vaccination were available.
OPA titers against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was an antibody titer ≥ 8.
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=20 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=16 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=21 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=9 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=13 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=8 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-6A
|
—
|
—
|
—
|
79 Titers
Interval 25.5 to 245.4
|
151.1 Titers
Interval 27.2 to 838.2
|
26.4 Titers
Interval 9.0 to 77.0
|
100.7 Titers
Interval 21.7 to 466.4
|
34.2 Titers
Interval 6.4 to 184.1
|
44.5 Titers
Interval 4.8 to 411.3
|
—
|
—
|
—
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-1
|
—
|
—
|
—
|
69.4 Titers
Interval 26.5 to 182.0
|
67.9 Titers
Interval 28.9 to 159.6
|
75.9 Titers
Interval 32.5 to 177.0
|
23 Titers
Interval 6.1 to 86.8
|
94 Titers
Interval 31.8 to 277.8
|
64.4 Titers
Interval 12.9 to 320.8
|
—
|
—
|
—
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-4
|
—
|
—
|
—
|
1311 Titers
Interval 848.8 to 2024.8
|
1172.3 Titers
Interval 639.7 to 2148.3
|
1027.7 Titers
Interval 573.0 to 1843.1
|
684.8 Titers
Interval 211.7 to 2215.5
|
1712.4 Titers
Interval 857.0 to 3421.6
|
777.2 Titers
Interval 119.2 to 5068.1
|
—
|
—
|
—
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-5
|
—
|
—
|
—
|
86.6 Titers
Interval 45.0 to 167.0
|
52.4 Titers
Interval 28.2 to 97.6
|
74.3 Titers
Interval 40.6 to 136.1
|
38.7 Titers
Interval 14.5 to 103.0
|
70.7 Titers
Interval 29.8 to 167.7
|
80.8 Titers
Interval 16.5 to 395.0
|
—
|
—
|
—
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-6B
|
—
|
—
|
—
|
723 Titers
Interval 434.8 to 1202.3
|
882.4 Titers
Interval 331.1 to 2351.7
|
361.3 Titers
Interval 125.7 to 1038.4
|
739.9 Titers
Interval 346.5 to 1580.0
|
140.3 Titers
Interval 27.6 to 712.2
|
237.1 Titers
Interval 30.5 to 1839.6
|
—
|
—
|
—
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-7F
|
—
|
—
|
—
|
8827.7 Titers
Interval 5905.7 to 13195.4
|
4977.9 Titers
Interval 3312.3 to 7481.1
|
6444.8 Titers
Interval 3781.0 to 10985.5
|
8362.7 Titers
Interval 4221.1 to 16567.7
|
7306.4 Titers
Interval 4248.7 to 12564.7
|
6286.1 Titers
Interval 3990.3 to 9902.8
|
—
|
—
|
—
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-9V
|
—
|
—
|
—
|
3429.2 Titers
Interval 2184.2 to 5384.0
|
4040.4 Titers
Interval 1816.6 to 8986.3
|
2744.2 Titers
Interval 1307.7 to 5758.7
|
5520.1 Titers
Interval 2214.2 to 13762.0
|
3777.1 Titers
Interval 1309.9 to 10891.1
|
2273.2 Titers
Interval 1339.4 to 3858.3
|
—
|
—
|
—
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-14
|
—
|
—
|
—
|
1346.3 Titers
Interval 522.8 to 3467.0
|
1219.7 Titers
Interval 551.1 to 2699.6
|
1417.9 Titers
Interval 940.6 to 2137.3
|
591.5 Titers
Interval 121.6 to 2877.4
|
1780.5 Titers
Interval 811.9 to 3905.0
|
1460.1 Titers
Interval 777.2 to 2742.9
|
—
|
—
|
—
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-18C
|
—
|
—
|
—
|
186.9 Titers
Interval 129.5 to 269.8
|
167.6 Titers
Interval 67.4 to 417.2
|
135.9 Titers
Interval 51.4 to 359.5
|
91.6 Titers
Interval 13.7 to 611.6
|
382.7 Titers
Interval 136.0 to 1076.8
|
106 Titers
Interval 22.2 to 507.2
|
—
|
—
|
—
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-19F
|
—
|
—
|
—
|
536.2 Titers
Interval 361.9 to 794.5
|
514.8 Titers
Interval 346.7 to 764.3
|
267.9 Titers
Interval 110.4 to 650.3
|
501.1 Titers
Interval 247.4 to 1015.3
|
254.2 Titers
Interval 59.1 to 1093.9
|
272.1 Titers
Interval 45.0 to 1646.0
|
—
|
—
|
—
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-23F
|
—
|
—
|
—
|
989.8 Titers
Interval 298.1 to 3286.3
|
1105.5 Titers
Interval 323.9 to 3772.4
|
1296 Titers
Interval 473.4 to 3548.1
|
1188.4 Titers
Interval 206.0 to 6855.2
|
723 Titers
Interval 137.3 to 3805.9
|
838.4 Titers
Interval 111.4 to 6313.2
|
—
|
—
|
—
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-19A
|
—
|
—
|
—
|
16.6 Titers
Interval 4.8 to 57.6
|
46.1 Titers
Interval 13.4 to 158.2
|
20.4 Titers
Interval 5.3 to 79.2
|
11.2 Titers
Interval 2.1 to 59.9
|
39.7 Titers
Interval 9.9 to 158.5
|
11.4 Titers
Interval 0.4 to 315.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
OPA titers against pneumococcal serotypes (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. When the number of subjects in a group for a specific category equals (=) 1, the lower limit and upper limit of the confidence interval that can't be calculated, are filled in with the GMT value (due to system constraint). Placeholder value "99999.9" has been entered when value to be entered in the system was greater than (\>) 1.0 E10.
Outcome measures
| Measure |
IPARA-NPARA Group
n=9 Participants
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=11 Participants
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=8 Participants
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=6 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=6 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=4 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=5 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=8 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=8 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
n=9 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=5 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=4 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-19A, M10
|
44.3 Titers
Interval 0.2 to 11784.5
|
416.5 Titers
Interval 108.9 to 1593.0
|
541.6 Titers
Interval 22.0 to 13332.7
|
363.7 Titers
Interval 0.0 to 5716540.0
|
4 Titers
Interval 4.0 to 4.0
|
21.2 Titers
Interval 0.0 to 99999.9
|
28 Titers
Interval 0.4 to 1990.5
|
29.8 Titers
Interval 0.0 to 169123.8
|
325.4 Titers
Interval 1.9 to 56037.4
|
125.7 Titers
Interval 25.1 to 627.8
|
253 Titers
Interval 253.0 to 253.0
|
12.8 Titers
Interval 0.0 to 33779569.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-6B, M9
|
127.7 Titers
Interval 6.1 to 2672.4
|
105.6 Titers
Interval 22.7 to 492.5
|
239 Titers
Interval 239.0 to 239.0
|
96.1 Titers
Interval 0.1 to 90019.7
|
237.2 Titers
Interval 86.5 to 650.7
|
84.3 Titers
Interval 0.1 to 63745.1
|
13.3 Titers
Interval 0.0 to 54806323.0
|
289.4 Titers
Interval 9.8 to 8513.4
|
208.9 Titers
Interval 12.9 to 3385.1
|
16.4 Titers
Interval 1.2 to 229.5
|
13.7 Titers
Interval 0.0 to 86126942.0
|
182.5 Titers
Interval 18.9 to 1765.4
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-6B, M10
|
431.5 Titers
Interval 26.4 to 7055.2
|
904.3 Titers
Interval 416.8 to 1961.9
|
376.5 Titers
Interval 92.7 to 1529.8
|
745.6 Titers
Interval 129.8 to 4282.1
|
606.2 Titers
Interval 42.0 to 8748.2
|
769.1 Titers
Interval 98.3 to 6016.6
|
694.2 Titers
Interval 296.4 to 1626.1
|
553.1 Titers
Interval 61.9 to 4943.5
|
1021.6 Titers
Interval 405.4 to 2574.3
|
237.6 Titers
Interval 50.1 to 1127.3
|
173.1 Titers
Interval 2.0 to 14809.0
|
1047.8 Titers
Interval 203.5 to 5394.1
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-7F, M9
|
1290.9 Titers
Interval 705.0 to 2363.9
|
2256.2 Titers
Interval 1405.5 to 3622.0
|
1744.7 Titers
Interval 1196.4 to 2544.2
|
2076 Titers
Interval 972.0 to 4433.7
|
1777.3 Titers
Interval 826.6 to 3821.5
|
1762.5 Titers
Interval 499.8 to 6215.0
|
1729.9 Titers
Interval 44.7 to 66995.8
|
5343.2 Titers
Interval 1372.2 to 20805.0
|
3522.8 Titers
Interval 1918.3 to 6469.5
|
2563 Titers
Interval 1240.6 to 5295.2
|
1152 Titers
Interval 421.9 to 3145.6
|
1263.5 Titers
Interval 941.3 to 1696.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-7F, M10
|
11414.1 Titers
Interval 394.1 to 330587.3
|
21670 Titers
Interval 6757.9 to 69487.8
|
7567.3 Titers
Interval 2674.9 to 21408.2
|
16259.9 Titers
Interval 3902.8 to 67742.7
|
4591.4 Titers
Interval 1411.4 to 14936.5
|
12162.6 Titers
Interval 776.4 to 190521.8
|
11741 Titers
Interval 6560.1 to 21013.7
|
9941.8 Titers
Interval 8127.1 to 12161.8
|
5744.5 Titers
Interval 1641.0 to 20109.7
|
14362.4 Titers
Interval 7145.2 to 28869.5
|
3565.8 Titers
Interval 921.7 to 13795.9
|
5829.1 Titers
Interval 2843.0 to 11951.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-9V, M9
|
567.4 Titers
Interval 200.7 to 1604.5
|
480.9 Titers
Interval 277.4 to 833.4
|
738.7 Titers
Interval 380.4 to 1434.4
|
830 Titers
Interval 289.3 to 2381.0
|
1283.8 Titers
Interval 523.1 to 3150.9
|
649.4 Titers
Interval 55.7 to 7568.6
|
1302.7 Titers
Interval 463.1 to 3664.3
|
1423.6 Titers
Interval 322.4 to 6284.8
|
1081.9 Titers
Interval 332.8 to 3517.5
|
1075.2 Titers
Interval 296.2 to 3903.4
|
282.1 Titers
Interval 31.3 to 2546.4
|
1571.3 Titers
Interval 115.1 to 21457.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-9V, M10
|
856.6 Titers
Interval 128.2 to 5724.3
|
7262.2 Titers
Interval 2971.8 to 17746.7
|
1340.1 Titers
Interval 362.0 to 4961.2
|
4969 Titers
Interval 1397.5 to 17668.0
|
7041.7 Titers
Interval 275.3 to 180111.2
|
4756.1 Titers
Interval 1023.5 to 22100.8
|
4190.8 Titers
Interval 2825.5 to 6215.9
|
3772.9 Titers
Interval 80.6 to 176558.2
|
4970.9 Titers
Interval 936.8 to 26377.0
|
4218.9 Titers
Interval 1894.6 to 9394.3
|
2919.8 Titers
Interval 474.0 to 17985.0
|
8601.7 Titers
Interval 382.8 to 193287.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-14, M9
|
98.3 Titers
Interval 15.8 to 613.0
|
260.7 Titers
Interval 132.9 to 511.3
|
195.4 Titers
Interval 12.5 to 3045.4
|
149.2 Titers
Interval 9.9 to 2241.1
|
255.1 Titers
Interval 16.7 to 3888.7
|
47.2 Titers
Interval 0.0 to 99999.9
|
737.1 Titers
Interval 1.4 to 400658.5
|
791.7 Titers
Interval 200.6 to 3124.5
|
539.2 Titers
Interval 251.1 to 1157.8
|
295 Titers
Interval 23.9 to 3647.4
|
255.9 Titers
Interval 99.2 to 660.2
|
382.6 Titers
Interval 115.3 to 1269.1
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-14, M10
|
557.5 Titers
Interval 17.8 to 17418.8
|
2288 Titers
Interval 761.1 to 6878.7
|
587.5 Titers
Interval 42.6 to 8103.2
|
1592.9 Titers
Interval 687.7 to 3689.5
|
671.4 Titers
Interval 14.8 to 30474.3
|
4426.6 Titers
Interval 692.4 to 28298.7
|
1507.6 Titers
Interval 358.0 to 6348.6
|
2002 Titers
Interval 134.3 to 29839.5
|
1312.4 Titers
Interval 226.7 to 7597.8
|
1498.1 Titers
Interval 672.9 to 3335.6
|
935.3 Titers
Interval 301.9 to 2897.7
|
3817 Titers
Interval 1256.3 to 11596.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-18C, M9
|
6.5 Titers
Interval 3.1 to 13.6
|
19.1 Titers
Interval 6.5 to 56.3
|
14 Titers
Interval 2.7 to 71.5
|
7.2 Titers
Interval 1.1 to 45.6
|
7.2 Titers
Interval 1.4 to 35.9
|
4 Titers
Interval 4.0 to 4.0
|
11.5 Titers
Interval 0.0 to 7631549.0
|
21.9 Titers
Interval 2.3 to 205.5
|
10.9 Titers
Interval 3.2 to 37.4
|
31.9 Titers
Interval 5.9 to 174.0
|
9.4 Titers
Interval 3.4 to 25.9
|
5.5 Titers
Interval 2.0 to 14.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-18C, M10
|
149.9 Titers
Interval 2.8 to 8106.0
|
888.9 Titers
Interval 225.5 to 3502.9
|
242.7 Titers
Interval 24.7 to 2382.5
|
912.9 Titers
Interval 365.4 to 2280.6
|
207.3 Titers
Interval 2.1 to 20168.5
|
2394.7 Titers
Interval 2.7 to 2123879.0
|
397.3 Titers
Interval 71.5 to 2207.5
|
650.6 Titers
Interval 82.6 to 5122.3
|
298.1 Titers
Interval 14.4 to 6180.8
|
428.6 Titers
Interval 155.3 to 1183.2
|
707.9 Titers
Interval 6.7 to 74589.3
|
481.3 Titers
Interval 128.3 to 1804.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-19F, M9
|
11 Titers
Interval 5.0 to 24.3
|
42.3 Titers
Interval 16.4 to 109.6
|
48.4 Titers
Interval 12.9 to 181.2
|
63 Titers
Interval 10.7 to 370.1
|
32.1 Titers
Interval 4.2 to 247.3
|
88.5 Titers
Interval 0.7 to 11624.3
|
9.7 Titers
Interval 0.2 to 438.0
|
17.7 Titers
Interval 1.4 to 226.2
|
67.8 Titers
Interval 19.0 to 242.3
|
15 Titers
Interval 5.7 to 39.2
|
24.2 Titers
Interval 5.9 to 98.4
|
53.2 Titers
Interval 7.7 to 365.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-23F, M9
|
89.4 Titers
Interval 4.8 to 1668.6
|
274.5 Titers
Interval 30.2 to 2491.4
|
37.7 Titers
Interval 0.8 to 1716.9
|
27.9 Titers
Interval 1.0 to 771.2
|
132.4 Titers
Interval 2.3 to 7484.5
|
22.2 Titers
Interval 0.0 to 35490.8
|
29.7 Titers
Interval 0.0 to 99999.9
|
134 Titers
Interval 2.2 to 8194.2
|
396.6 Titers
Interval 19.4 to 8113.1
|
499.7 Titers
Interval 54.2 to 4605.6
|
30.5 Titers
Interval 0.0 to 190610.3
|
15.6 Titers
Interval 1.1 to 212.9
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-19F, M10
|
163.3 Titers
Interval 8.6 to 3091.2
|
1215.3 Titers
Interval 222.2 to 6647.8
|
511 Titers
Interval 59.2 to 4412.4
|
1112.9 Titers
Interval 289.7 to 4274.9
|
330.5 Titers
Interval 32.2 to 3390.7
|
2575.2 Titers
Interval 120.5 to 55029.6
|
637.1 Titers
Interval 262.3 to 1547.9
|
1040.7 Titers
Interval 12.0 to 90618.7
|
1575 Titers
Interval 246.7 to 10054.3
|
572.7 Titers
Interval 332.3 to 986.9
|
273.9 Titers
Interval 0.0 to 2588316.0
|
250.6 Titers
Interval 70.4 to 892.1
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-6A, M10
|
154 Titers
Interval 8.4 to 2814.5
|
159.1 Titers
Interval 9.9 to 2554.8
|
78.5 Titers
Interval 10.4 to 592.3
|
183.7 Titers
Interval 7.3 to 4625.8
|
125.4 Titers
Interval 14.0 to 1123.6
|
318.4 Titers
Interval 160.1 to 632.9
|
581.1 Titers
Interval 220.5 to 1531.4
|
74.5 Titers
Interval 0.1 to 40934.6
|
169.2 Titers
Interval 2.9 to 9717.7
|
98.1 Titers
Interval 21.0 to 458.5
|
106.9 Titers
Interval 6.5 to 1749.7
|
120 Titers
Interval 0.1 to 185061.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-23F, M10
|
297 Titers
Interval 2.0 to 44387.7
|
1436.2 Titers
Interval 114.1 to 18085.7
|
875.2 Titers
Interval 92.2 to 8311.0
|
581 Titers
Interval 14.5 to 23210.4
|
2381.5 Titers
Interval 861.8 to 6581.0
|
2792.9 Titers
Interval 391.0 to 19949.8
|
2977.7 Titers
Interval 687.2 to 12903.5
|
2096.1 Titers
Interval 823.2 to 5337.4
|
3530.1 Titers
Interval 1606.2 to 7758.5
|
4249.1 Titers
Interval 2398.0 to 7529.2
|
3682.7 Titers
Interval 1187.0 to 11426.0
|
1464.1 Titers
Interval 437.9 to 4895.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-6A, M9
|
46.7 Titers
Interval 5.1 to 428.4
|
84 Titers
Interval 11.2 to 631.4
|
24.5 Titers
Interval 4.1 to 148.1
|
39.8 Titers
Interval 0.6 to 2715.5
|
45.1 Titers
Interval 2.8 to 721.4
|
13.4 Titers
Interval 0.1 to 2451.0
|
239.5 Titers
Interval 21.3 to 2696.8
|
224.8 Titers
Interval 41.3 to 1222.9
|
99 Titers
Interval 12.8 to 765.5
|
23.3 Titers
Interval 3.0 to 180.7
|
34.1 Titers
Interval 1.5 to 760.2
|
58.3 Titers
Interval 1.3 to 2537.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-19A, M9
|
4 Titers
Interval 4.0 to 4.0
|
9.1 Titers
Interval 2.5 to 33.5
|
4 Titers
Interval 4.0 to 4.0
|
4 Titers
Interval 4.0 to 4.0
|
4 Titers
Interval 4.0 to 4.0
|
4 Titers
Interval 4.0 to 4.0
|
4 Titers
Interval 4.0 to 4.0
|
7.4 Titers
Interval 1.5 to 36.3
|
4 Titers
Interval 4.0 to 4.0
|
4 Titers
Interval 4.0 to 4.0
|
4 Titers
Interval 4.0 to 4.0
|
4 Titers
Interval 4.0 to 4.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-1, M9
|
6 Titers
Interval 2.4 to 15.0
|
12.2 Titers
Interval 4.3 to 34.1
|
15.7 Titers
Interval 4.4 to 56.3
|
5.8 Titers
Interval 2.2 to 15.3
|
4 Titers
Interval 4.0 to 4.0
|
4 Titers
Interval 4.0 to 4.0
|
50.3 Titers
Interval 0.1 to 18959.2
|
50.6 Titers
Interval 10.3 to 248.5
|
9.9 Titers
Interval 2.2 to 44.5
|
7.3 Titers
Interval 1.7 to 31.9
|
40.2 Titers
Interval 2.5 to 638.5
|
10.7 Titers
Interval 0.5 to 242.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-1, M10
|
120.6 Titers
Interval 10.8 to 1346.5
|
736.3 Titers
Interval 184.7 to 2934.6
|
887.6 Titers
Interval 226.3 to 3481.1
|
346.2 Titers
Interval 96.8 to 1237.9
|
296.3 Titers
Interval 31.0 to 2828.6
|
316.4 Titers
Interval 96.8 to 1034.8
|
158 Titers
Interval 10.2 to 2438.7
|
248 Titers
Interval 67.5 to 911.1
|
344.4 Titers
Interval 105.7 to 1122.1
|
388.2 Titers
Interval 134.4 to 1121.8
|
546.2 Titers
Interval 75.4 to 3956.8
|
627 Titers
Interval 37.0 to 10621.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-4, M9
|
25.9 Titers
Interval 3.0 to 227.0
|
56.3 Titers
Interval 7.2 to 442.0
|
161.8 Titers
Interval 14.5 to 1807.7
|
34 Titers
Interval 0.7 to 1751.4
|
80.2 Titers
Interval 3.1 to 2046.3
|
4 Titers
Interval 4.0 to 4.0
|
9 Titers
Interval 9.0 to 9.0
|
407.6 Titers
Interval 178.5 to 930.7
|
74.2 Titers
Interval 10.1 to 546.3
|
98.1 Titers
Interval 13.7 to 703.0
|
52.4 Titers
Interval 4.0 to 681.7
|
15.2 Titers
Interval 2.9 to 80.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-4, M10
|
548.3 Titers
Interval 15.0 to 20011.5
|
1885.9 Titers
Interval 1047.9 to 3394.0
|
854.4 Titers
Interval 51.9 to 14066.3
|
928.1 Titers
Interval 309.6 to 2781.8
|
865.8 Titers
Interval 48.5 to 15451.2
|
2213.4 Titers
Interval 438.4 to 11174.3
|
2096.7 Titers
Interval 828.7 to 5304.9
|
1037.5 Titers
Interval 310.2 to 3469.2
|
1096.7 Titers
Interval 266.3 to 4516.1
|
1953.4 Titers
Interval 972.9 to 3922.2
|
1149.8 Titers
Interval 209.9 to 6297.3
|
1414.1 Titers
Interval 738.6 to 2707.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-5, M9
|
5.7 Titers
Interval 3.3 to 10.1
|
7.4 Titers
Interval 4.5 to 12.3
|
22.2 Titers
Interval 6.4 to 77.0
|
12.9 Titers
Interval 4.6 to 36.3
|
9.2 Titers
Interval 3.2 to 26.5
|
8.2 Titers
Interval 0.4 to 185.0
|
19 Titers
Interval 0.5 to 699.8
|
17.5 Titers
Interval 4.0 to 76.0
|
10.8 Titers
Interval 2.8 to 41.7
|
7.6 Titers
Interval 2.6 to 21.8
|
12.7 Titers
Interval 1.4 to 114.2
|
9.8 Titers
Interval 3.7 to 26.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPSONO-5, M10
|
42.2 Titers
Interval 6.3 to 283.0
|
125.3 Titers
Interval 43.6 to 360.3
|
149.7 Titers
Interval 27.8 to 806.0
|
131.8 Titers
Interval 77.7 to 223.6
|
93.3 Titers
Interval 15.5 to 562.2
|
241.7 Titers
Interval 19.1 to 3061.6
|
79 Titers
Interval 7.6 to 826.1
|
114.1 Titers
Interval 17.2 to 758.5
|
165.8 Titers
Interval 75.4 to 364.8
|
99.5 Titers
Interval 36.2 to 273.8
|
128.9 Titers
Interval 16.8 to 989.4
|
184.6 Titers
Interval 20.4 to 1671.3
|
SECONDARY outcome
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U//mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 100 EL.U/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
n=50 Participants
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=48 Participants
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=48 Participants
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=49 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=45 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=43 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=48 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=48 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=46 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
n=47 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=47 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=46 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Protein D (Anti-PD)
Anti-PD, M9
|
446.1 EL.U/mL
Interval 331.1 to 601.0
|
525.4 EL.U/mL
Interval 367.8 to 750.4
|
691.3 EL.U/mL
Interval 550.1 to 868.8
|
661.6 EL.U/mL
Interval 517.8 to 845.4
|
660.4 EL.U/mL
Interval 501.1 to 870.4
|
588.3 EL.U/mL
Interval 431.8 to 801.5
|
622.9 EL.U/mL
Interval 472.0 to 821.9
|
590 EL.U/mL
Interval 456.3 to 763.0
|
502 EL.U/mL
Interval 376.6 to 669.2
|
752.1 EL.U/mL
Interval 561.2 to 1008.0
|
555.1 EL.U/mL
Interval 423.1 to 728.2
|
777.2 EL.U/mL
Interval 561.4 to 1076.0
|
|
Antibody Concentrations Against Protein D (Anti-PD)
Anti-PD M10
|
1482.7 EL.U/mL
Interval 1077.1 to 2040.9
|
1517.3 EL.U/mL
Interval 1134.5 to 2029.2
|
2082.5 EL.U/mL
Interval 1634.9 to 2652.5
|
2069 EL.U/mL
Interval 1639.7 to 2610.8
|
1980.1 EL.U/mL
Interval 1484.1 to 2641.8
|
1907.5 EL.U/mL
Interval 1330.9 to 2733.9
|
1888.7 EL.U/mL
Interval 1349.3 to 2643.6
|
1664.8 EL.U/mL
Interval 1283.0 to 2160.2
|
1540.7 EL.U/mL
Interval 1108.6 to 2141.2
|
2319.7 EL.U/mL
Interval 1701.9 to 3161.8
|
1953.1 EL.U/mL
Interval 1541.5 to 2474.5
|
2285.5 EL.U/mL
Interval 1724.1 to 3029.7
|
SECONDARY outcome
Timeframe: One month after primary immunization (Month 3)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=137 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=150 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=153 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=50 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=49 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=53 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-D
|
—
|
—
|
—
|
3.326 IU/mL
Interval 2.97 to 3.725
|
2.938 IU/mL
Interval 2.651 to 3.257
|
3.132 IU/mL
Interval 2.801 to 3.503
|
3.062 IU/mL
Interval 2.565 to 3.655
|
2.891 IU/mL
Interval 2.324 to 3.597
|
3.457 IU/mL
Interval 2.907 to 4.109
|
—
|
—
|
—
|
|
Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-T
|
—
|
—
|
—
|
3.746 IU/mL
Interval 3.305 to 4.245
|
3.373 IU/mL
Interval 3.043 to 3.738
|
3.961 IU/mL
Interval 3.516 to 4.461
|
2.943 IU/mL
Interval 2.434 to 3.559
|
3.058 IU/mL
Interval 2.545 to 3.676
|
3.762 IU/mL
Interval 3.105 to 4.558
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in IU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
n=47 Participants
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=44 Participants
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=47 Participants
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=48 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=44 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=40 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=46 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=46 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=45 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
n=43 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=45 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=43 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids
Anti-D, M9
|
0.665 IU/mL
Interval 0.552 to 0.8
|
0.546 IU/mL
Interval 0.417 to 0.715
|
0.642 IU/mL
Interval 0.518 to 0.795
|
0.736 IU/mL
Interval 0.556 to 0.975
|
0.593 IU/mL
Interval 0.476 to 0.739
|
0.616 IU/mL
Interval 0.499 to 0.762
|
0.55 IU/mL
Interval 0.439 to 0.69
|
0.581 IU/mL
Interval 0.428 to 0.788
|
0.628 IU/mL
Interval 0.483 to 0.815
|
0.714 IU/mL
Interval 0.581 to 0.876
|
0.627 IU/mL
Interval 0.509 to 0.774
|
0.656 IU/mL
Interval 0.514 to 0.836
|
|
Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids
Anti-D, M10
|
7.238 IU/mL
Interval 5.322 to 9.845
|
6.477 IU/mL
Interval 5.069 to 8.277
|
6.749 IU/mL
Interval 4.931 to 9.237
|
7.492 IU/mL
Interval 5.932 to 9.463
|
5.257 IU/mL
Interval 4.033 to 6.853
|
7.57 IU/mL
Interval 5.512 to 10.396
|
5.926 IU/mL
Interval 4.752 to 7.39
|
5.831 IU/mL
Interval 4.642 to 7.324
|
6.486 IU/mL
Interval 4.778 to 8.805
|
7.059 IU/mL
Interval 5.455 to 9.136
|
7.226 IU/mL
Interval 5.872 to 8.892
|
8.206 IU/mL
Interval 6.869 to 9.802
|
|
Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids
Anti-T, M9
|
0.666 IU/mL
Interval 0.523 to 0.849
|
0.698 IU/mL
Interval 0.538 to 0.907
|
0.9 IU/mL
Interval 0.707 to 1.146
|
0.838 IU/mL
Interval 0.661 to 1.062
|
0.735 IU/mL
Interval 0.573 to 0.944
|
0.66 IU/mL
Interval 0.519 to 0.839
|
0.681 IU/mL
Interval 0.538 to 0.862
|
0.868 IU/mL
Interval 0.668 to 1.13
|
0.692 IU/mL
Interval 0.531 to 0.901
|
0.843 IU/mL
Interval 0.661 to 1.076
|
0.883 IU/mL
Interval 0.686 to 1.136
|
0.858 IU/mL
Interval 0.671 to 1.097
|
|
Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids
Anti-T, M10
|
6.491 IU/mL
Interval 4.93 to 8.546
|
7.431 IU/mL
Interval 5.672 to 9.736
|
7.423 IU/mL
Interval 5.625 to 9.796
|
8.03 IU/mL
Interval 6.347 to 10.159
|
6.887 IU/mL
Interval 5.372 to 8.829
|
7.283 IU/mL
Interval 5.179 to 10.243
|
7.092 IU/mL
Interval 5.734 to 8.772
|
7.269 IU/mL
Interval 5.916 to 8.932
|
6.522 IU/mL
Interval 4.886 to 8.707
|
7.095 IU/mL
Interval 5.32 to 9.461
|
10.8 IU/mL
Interval 8.799 to 13.254
|
9.045 IU/mL
Interval 7.659 to 10.681
|
SECONDARY outcome
Timeframe: One month after primary immunization (Month 3)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=138 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=149 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=155 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=47 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=48 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=53 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Anti-PT
|
—
|
—
|
—
|
59.1 EL.U/mL
Interval 53.7 to 65.1
|
64.2 EL.U/mL
Interval 58.7 to 70.2
|
65 EL.U/mL
Interval 59.6 to 71.0
|
60.4 EL.U/mL
Interval 51.4 to 71.0
|
63.1 EL.U/mL
Interval 52.0 to 76.6
|
61.5 EL.U/mL
Interval 53.1 to 71.2
|
—
|
—
|
—
|
|
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Anti-FHA
|
—
|
—
|
—
|
163.1 EL.U/mL
Interval 147.8 to 180.1
|
171.6 EL.U/mL
Interval 154.7 to 190.4
|
191.1 EL.U/mL
Interval 171.1 to 213.5
|
171 EL.U/mL
Interval 139.8 to 209.2
|
196.5 EL.U/mL
Interval 163.1 to 236.8
|
168.9 EL.U/mL
Interval 141.9 to 201.0
|
—
|
—
|
—
|
|
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Anti-PRN
|
—
|
—
|
—
|
103.9 EL.U/mL
Interval 91.5 to 118.0
|
114.3 EL.U/mL
Interval 101.0 to 129.3
|
118.1 EL.U/mL
Interval 103.9 to 134.3
|
97.1 EL.U/mL
Interval 76.7 to 123.1
|
106.2 EL.U/mL
Interval 83.1 to 135.7
|
114 EL.U/mL
Interval 95.6 to 136.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
n=49 Participants
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=44 Participants
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=47 Participants
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=48 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=45 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=40 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=46 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=46 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=45 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
n=45 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=45 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=44 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Anti-PT, M9
|
13 EL.U/mL
Interval 10.6 to 16.1
|
10.8 EL.U/mL
Interval 8.6 to 13.7
|
14.2 EL.U/mL
Interval 10.5 to 19.1
|
13.3 EL.U/mL
Interval 10.8 to 16.3
|
12.8 EL.U/mL
Interval 11.0 to 14.9
|
10.5 EL.U/mL
Interval 8.2 to 13.3
|
14.7 EL.U/mL
Interval 11.1 to 19.6
|
14.2 EL.U/mL
Interval 11.4 to 17.8
|
13.6 EL.U/mL
Interval 11.1 to 16.7
|
12.8 EL.U/mL
Interval 9.9 to 16.7
|
12 EL.U/mL
Interval 9.1 to 15.9
|
15.2 EL.U/mL
Interval 12.4 to 18.5
|
|
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Anti-PT, M10
|
59.4 EL.U/mL
Interval 46.8 to 75.2
|
66.8 EL.U/mL
Interval 50.6 to 88.3
|
57 EL.U/mL
Interval 42.2 to 77.1
|
73.8 EL.U/mL
Interval 58.9 to 92.5
|
64.4 EL.U/mL
Interval 50.4 to 82.3
|
56.6 EL.U/mL
Interval 39.9 to 80.5
|
72.3 EL.U/mL
Interval 57.7 to 90.6
|
75.5 EL.U/mL
Interval 59.4 to 95.9
|
74.8 EL.U/mL
Interval 56.9 to 98.2
|
63.4 EL.U/mL
Interval 48.0 to 83.6
|
74.9 EL.U/mL
Interval 60.0 to 93.4
|
97.6 EL.U/mL
Interval 82.5 to 115.5
|
|
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Anti-FHA, M9
|
50.8 EL.U/mL
Interval 42.1 to 61.3
|
48.5 EL.U/mL
Interval 39.7 to 59.3
|
52.9 EL.U/mL
Interval 39.1 to 71.7
|
46.1 EL.U/mL
Interval 36.7 to 57.9
|
42.6 EL.U/mL
Interval 34.5 to 52.6
|
42.6 EL.U/mL
Interval 33.3 to 54.5
|
53.8 EL.U/mL
Interval 40.2 to 72.2
|
59.3 EL.U/mL
Interval 44.1 to 79.8
|
57.7 EL.U/mL
Interval 41.7 to 79.9
|
57.9 EL.U/mL
Interval 42.5 to 78.8
|
45.7 EL.U/mL
Interval 36.3 to 57.6
|
59.1 EL.U/mL
Interval 46.4 to 75.1
|
|
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Anti-FHA, M10
|
321 EL.U/mL
Interval 246.5 to 417.9
|
332.9 EL.U/mL
Interval 258.2 to 429.3
|
294.2 EL.U/mL
Interval 224.3 to 385.9
|
308.8 EL.U/mL
Interval 247.1 to 385.9
|
252.7 EL.U/mL
Interval 195.1 to 327.4
|
327.2 EL.U/mL
Interval 240.9 to 444.4
|
359.8 EL.U/mL
Interval 289.2 to 447.6
|
322.9 EL.U/mL
Interval 252.2 to 413.4
|
332.7 EL.U/mL
Interval 250.9 to 441.2
|
312.3 EL.U/mL
Interval 238.7 to 408.8
|
338.6 EL.U/mL
Interval 270.3 to 424.3
|
442.8 EL.U/mL
Interval 370.6 to 529.0
|
|
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Anti-PRN, M9
|
20.1 EL.U/mL
Interval 14.7 to 27.6
|
19.7 EL.U/mL
Interval 14.6 to 26.7
|
20.3 EL.U/mL
Interval 14.3 to 29.0
|
15.7 EL.U/mL
Interval 11.8 to 21.1
|
16 EL.U/mL
Interval 12.9 to 19.9
|
18.3 EL.U/mL
Interval 13.8 to 24.4
|
22.4 EL.U/mL
Interval 16.5 to 30.5
|
25.1 EL.U/mL
Interval 18.5 to 34.0
|
16 EL.U/mL
Interval 11.6 to 22.1
|
19.4 EL.U/mL
Interval 13.5 to 27.9
|
18.8 EL.U/mL
Interval 14.1 to 24.9
|
27.3 EL.U/mL
Interval 20.9 to 35.7
|
|
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Anti-PRN, M10
|
205.1 EL.U/mL
Interval 148.5 to 283.5
|
214.2 EL.U/mL
Interval 151.8 to 302.3
|
213.6 EL.U/mL
Interval 151.2 to 301.8
|
218.6 EL.U/mL
Interval 162.4 to 294.3
|
173.5 EL.U/mL
Interval 131.0 to 229.8
|
225.9 EL.U/mL
Interval 145.9 to 349.8
|
262.9 EL.U/mL
Interval 196.5 to 351.7
|
246.2 EL.U/mL
Interval 182.5 to 332.0
|
184.3 EL.U/mL
Interval 122.6 to 277.1
|
226.7 EL.U/mL
Interval 162.6 to 316.1
|
255.7 EL.U/mL
Interval 189.9 to 344.3
|
330.4 EL.U/mL
Interval 263.9 to 413.7
|
SECONDARY outcome
Timeframe: One month after primary immunization (Month 3)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=111 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=119 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=120 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=40 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=36 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=44 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)
|
—
|
—
|
—
|
911.85 mIU/mL
Interval 719.55 to 1155.56
|
1139.1 mIU/mL
Interval 902.93 to 1437.04
|
1245.07 mIU/mL
Interval 998.97 to 1551.8
|
934.65 mIU/mL
Interval 580.7 to 1504.32
|
674.25 mIU/mL
Interval 373.26 to 1217.95
|
1027.79 mIU/mL
Interval 719.24 to 1468.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
n=37 Participants
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=37 Participants
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=36 Participants
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=43 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=39 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=30 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=41 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=38 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=40 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
n=34 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=37 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=40 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Hepatitis B Surface Antigen
Anti-HBs, M9
|
128.12 mIU/mL
Interval 78.68 to 208.6
|
199.57 mIU/mL
Interval 115.04 to 346.22
|
209.27 mIU/mL
Interval 121.25 to 361.16
|
197.46 mIU/mL
Interval 125.7 to 310.18
|
210.32 mIU/mL
Interval 125.47 to 352.56
|
164.33 mIU/mL
Interval 98.38 to 274.49
|
136.53 mIU/mL
Interval 77.08 to 241.83
|
225.01 mIU/mL
Interval 135.08 to 374.83
|
194.51 mIU/mL
Interval 128.13 to 295.29
|
226.1 mIU/mL
Interval 134.4 to 380.39
|
244.52 mIU/mL
Interval 133.36 to 448.35
|
159.79 mIU/mL
Interval 96.78 to 263.8
|
|
Antibody Concentrations Against Hepatitis B Surface Antigen
Anti-HBs, M10
|
2078.63 mIU/mL
Interval 1261.91 to 3423.92
|
2003.09 mIU/mL
Interval 1040.72 to 3855.37
|
2218.23 mIU/mL
Interval 1219.17 to 4035.97
|
1949.42 mIU/mL
Interval 1220.13 to 3114.61
|
1898.54 mIU/mL
Interval 1147.47 to 3141.21
|
1970.6 mIU/mL
Interval 1017.24 to 3817.44
|
1685.87 mIU/mL
Interval 1012.93 to 2805.87
|
2492.42 mIU/mL
Interval 1638.97 to 3790.27
|
2107.75 mIU/mL
Interval 1257.97 to 3531.56
|
1851.22 mIU/mL
Interval 1033.84 to 3314.85
|
2579.59 mIU/mL
Interval 1575.91 to 4222.52
|
3244.33 mIU/mL
Interval 2235.34 to 4708.75
|
SECONDARY outcome
Timeframe: One month after primary immunization (Month 3)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=136 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=147 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=150 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=52 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=47 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=53 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)
|
—
|
—
|
—
|
3.994 µg/mL
Interval 3.268 to 4.882
|
3.66 µg/mL
Interval 3.073 to 4.359
|
4.51 µg/mL
Interval 3.753 to 5.419
|
3.29 µg/mL
Interval 2.362 to 4.583
|
4.23 µg/mL
Interval 3.025 to 5.914
|
5.007 µg/mL
Interval 3.69 to 6.793
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in µg/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.
Outcome measures
| Measure |
IPARA-NPARA Group
n=47 Participants
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=44 Participants
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=47 Participants
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=48 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=45 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=40 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=46 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=47 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=45 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
n=45 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=45 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=44 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)
Anti-PRP, M9
|
0.696 µg/mL
Interval 0.5 to 0.967
|
0.651 µg/mL
Interval 0.452 to 0.938
|
0.953 µg/mL
Interval 0.655 to 1.386
|
0.878 µg/mL
Interval 0.609 to 1.266
|
0.684 µg/mL
Interval 0.48 to 0.974
|
0.678 µg/mL
Interval 0.436 to 1.055
|
0.824 µg/mL
Interval 0.554 to 1.226
|
0.847 µg/mL
Interval 0.571 to 1.256
|
0.763 µg/mL
Interval 0.51 to 1.141
|
0.798 µg/mL
Interval 0.518 to 1.231
|
0.72 µg/mL
Interval 0.531 to 0.977
|
1.013 µg/mL
Interval 0.689 to 1.491
|
|
Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)
Anti-PRP, M10
|
16.682 µg/mL
Interval 11.367 to 24.481
|
21.602 µg/mL
Interval 14.406 to 32.392
|
23.277 µg/mL
Interval 16.047 to 33.765
|
21.964 µg/mL
Interval 15.76 to 30.61
|
17.484 µg/mL
Interval 11.592 to 26.37
|
21.277 µg/mL
Interval 12.268 to 36.901
|
20.28 µg/mL
Interval 13.96 to 29.462
|
18.987 µg/mL
Interval 13.365 to 26.973
|
17.544 µg/mL
Interval 11.966 to 25.722
|
20.659 µg/mL
Interval 14.948 to 28.55
|
33.45 µg/mL
Interval 23.717 to 47.176
|
22.083 µg/mL
Interval 14.795 to 32.961
|
SECONDARY outcome
Timeframe: One month after primary immunization (Month 3)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.
Outcome measures
| Measure |
IPARA-NPARA Group
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=24 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=24 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=24 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=11 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=4 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=9 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Anti-Polio 1
|
—
|
—
|
—
|
283.4 Titers
Interval 175.5 to 457.6
|
252.5 Titers
Interval 156.9 to 406.2
|
337 Titers
Interval 204.2 to 556.2
|
225.6 Titers
Interval 103.2 to 492.8
|
166 Titers
Interval 97.9 to 281.4
|
449.3 Titers
Interval 127.6 to 1581.7
|
—
|
—
|
—
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Anti-Polio 2
|
—
|
—
|
—
|
362 Titers
Interval 259.1 to 505.9
|
327.4 Titers
Interval 196.8 to 544.8
|
378 Titers
Interval 234.9 to 608.1
|
240.7 Titers
Interval 121.9 to 475.3
|
394.8 Titers
Interval 99.5 to 1567.1
|
335.2 Titers
Interval 152.8 to 735.2
|
—
|
—
|
—
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Anti-Polio 3
|
—
|
—
|
—
|
423.2 Titers
Interval 255.2 to 701.9
|
351.3 Titers
Interval 236.4 to 522.1
|
624.1 Titers
Interval 394.5 to 987.4
|
284 Titers
Interval 151.3 to 533.3
|
394.8 Titers
Interval 153.9 to 1012.5
|
438.6 Titers
Interval 142.5 to 1349.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.
Outcome measures
| Measure |
IPARA-NPARA Group
n=10 Participants
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=4 Participants
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=5 Participants
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU Group
n=8 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=7 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=6 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=8 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=8 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=6 Participants
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU-IIBU Group
n=8 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=5 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=9 Participants
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Anti-Polio 1, M9
|
53.8 Titers
Interval 12.5 to 232.0
|
128.3 Titers
Interval 8.4 to 1971.9
|
117.4 Titers
Interval 12.7 to 1084.0
|
56 Titers
Interval 15.7 to 200.2
|
85.9 Titers
Interval 26.7 to 276.4
|
80.9 Titers
Interval 18.7 to 349.8
|
145.7 Titers
Interval 59.8 to 354.5
|
45.4 Titers
Interval 15.9 to 129.6
|
32.1 Titers
Interval 11.8 to 87.3
|
67.1 Titers
Interval 12.9 to 348.4
|
53.7 Titers
Interval 2.7 to 1083.7
|
141.2 Titers
Interval 54.2 to 368.0
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Anti-Polio 1, M10
|
1290.1 Titers
Interval 455.8 to 3651.2
|
1448.1 Titers
Interval 148.5 to 14125.5
|
861.1 Titers
Interval 74.6 to 9935.0
|
1378.2 Titers
Interval 682.4 to 2783.4
|
790.7 Titers
Interval 75.3 to 8304.9
|
429.9 Titers
Interval 35.6 to 5190.7
|
1824.5 Titers
Interval 831.6 to 4003.0
|
388 Titers
Interval 60.4 to 2494.6
|
543.9 Titers
Interval 79.4 to 3726.3
|
1217.7 Titers
Interval 327.7 to 4525.4
|
4 Titers
Interval 4.0 to 4.0
|
1075.9 Titers
Interval 546.1 to 2119.8
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Anti-Polio 2, M9
|
29.7 Titers
Interval 10.5 to 83.9
|
139.6 Titers
Interval 106.0 to 183.9
|
168.9 Titers
Interval 73.8 to 386.4
|
120.8 Titers
Interval 27.0 to 540.4
|
60.8 Titers
Interval 17.8 to 207.0
|
48.3 Titers
Interval 16.3 to 143.4
|
292.1 Titers
Interval 61.3 to 1391.9
|
41.7 Titers
Interval 19.6 to 88.5
|
8 Titers
Interval 0.0 to 53461.2
|
134.8 Titers
Interval 54.1 to 336.1
|
119.6 Titers
Interval 25.8 to 553.9
|
156.1 Titers
Interval 65.7 to 371.0
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Anti-Polio 2, M10
|
2047.9 Titers
Interval 1068.3 to 3925.7
|
1625.4 Titers
Interval 270.8 to 9756.8
|
1116.6 Titers
Interval 126.6 to 9848.8
|
1949 Titers
Interval 844.4 to 4498.6
|
1217.7 Titers
Interval 101.3 to 14638.5
|
548.7 Titers
Interval 41.2 to 7308.0
|
2151.9 Titers
Interval 715.2 to 6474.4
|
512.5 Titers
Interval 131.8 to 1993.2
|
542.4 Titers
Interval 41.7 to 7057.5
|
1217.7 Titers
Interval 195.5 to 7583.0
|
434.1 Titers
Interval 0.0 to 999999.0
|
1393.4 Titers
Interval 731.1 to 2655.7
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Anti-Polio 3, M9
|
96.5 Titers
Interval 12.3 to 758.1
|
108.1 Titers
Interval 62.5 to 186.8
|
69.7 Titers
Interval 2.2 to 2175.5
|
72 Titers
Interval 18.9 to 273.5
|
86 Titers
Interval 33.8 to 218.9
|
127.8 Titers
Interval 30.6 to 534.2
|
205.4 Titers
Interval 52.5 to 804.1
|
45.3 Titers
Interval 14.2 to 144.4
|
45.2 Titers
Interval 19.1 to 106.8
|
70 Titers
Interval 31.6 to 155.4
|
139.6 Titers
Interval 30.5 to 638.7
|
128 Titers
Interval 75.8 to 216.3
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Anti-Polio 3, M10
|
2195 Titers
Interval 889.0 to 5419.4
|
1625.4 Titers
Interval 436.4 to 6054.1
|
2048 Titers
Interval 2048.0 to 2048.0
|
861 Titers
Interval 363.5 to 2039.4
|
1724.5 Titers
Interval 66.3 to 44854.5
|
359.5 Titers
Interval 8.4 to 15474.7
|
3649.1 Titers
Interval 1721.5 to 7735.1
|
588.1 Titers
Interval 44.0 to 7860.3
|
1152.5 Titers
Interval 123.7 to 10737.5
|
558.3 Titers
Interval 140.6 to 2216.3
|
724.1 Titers
Interval 0.0 to 999999.0
|
2233.3 Titers
Interval 1122.1 to 4445.0
|
Adverse Events
IIBU Group
Serious events: 4 serious events
Other events: 181 other events
Deaths: 0 deaths
DIBU Group
Serious events: 4 serious events
Other events: 171 other events
Deaths: 0 deaths
NIBU Group
Serious events: 2 serious events
Other events: 186 other events
Deaths: 0 deaths
IPARA Group
Serious events: 4 serious events
Other events: 60 other events
Deaths: 0 deaths
DPARA Group
Serious events: 1 serious events
Other events: 61 other events
Deaths: 0 deaths
NPARA Group
Serious events: 0 serious events
Other events: 73 other events
Deaths: 0 deaths
IIBU-IIBU Group
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
IIBU-DIBU Group
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
IIBU-NIBU Group
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
DIBU-IIBU Group
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
DIBU-DIBU Group
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
DIBU-NIBU Group
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
NIBU-IIBU Group
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
NIBU-DIBU Group
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
NIBU-NIBU Group
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
IPARA-NPARA Group
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
DPARA-IPARA Group
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
NPARA-IPARA Group
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IIBU Group
n=198 participants at risk
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=198 participants at risk
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=199 participants at risk
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=71 participants at risk
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=72 participants at risk
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=74 participants at risk
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IIBU-IIBU Group
n=64 participants at risk
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU-DIBU Group
n=60 participants at risk
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU-NIBU Group
n=63 participants at risk
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-IIBU Group
n=63 participants at risk
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-DIBU Group
n=63 participants at risk
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-NIBU Group
n=63 participants at risk
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-IIBU Group
n=63 participants at risk
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=65 participants at risk
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=62 participants at risk
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IPARA-NPARA Group
n=67 participants at risk
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=68 participants at risk
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=67 participants at risk
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Otitis media
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.50%
1/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Injury, poisoning and procedural complications
Accidental poisoning
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.50%
1/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.5%
1/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.7%
1/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.50%
1/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
2.8%
2/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
2.8%
2/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.4%
1/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.5%
1/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.4%
1/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.4%
1/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Musculoskeletal and connective tissue disorders
Rickets
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Infections and infestations
Pneumonia
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.4%
1/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.4%
1/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Infections and infestations
Laryngitis
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Infections and infestations
Urinary tract infection
|
0.51%
1/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/198 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/199 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/74 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
Other adverse events
| Measure |
IIBU Group
n=198 participants at risk
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
|
DIBU Group
n=198 participants at risk
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NIBU Group
n=199 participants at risk
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IPARA Group
n=71 participants at risk
Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
DPARA Group
n=72 participants at risk
Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
NPARA Group
n=74 participants at risk
Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
|
IIBU-IIBU Group
n=64 participants at risk
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU-DIBU Group
n=60 participants at risk
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IIBU-NIBU Group
n=63 participants at risk
1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-IIBU Group
n=63 participants at risk
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-DIBU Group
n=63 participants at risk
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DIBU-NIBU Group
n=63 participants at risk
1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-IIBU Group
n=63 participants at risk
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-DIBU Group
n=65 participants at risk
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NIBU-NIBU Group
n=62 participants at risk
1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
IPARA-NPARA Group
n=67 participants at risk
Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
DPARA-IPARA Group
n=68 participants at risk
Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
NPARA-IPARA Group
n=67 participants at risk
Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pain
|
46.5%
92/198 • Number of events 154 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
38.4%
76/198 • Number of events 145 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
53.8%
107/199 • Number of events 197 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
42.3%
30/71 • Number of events 58 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
51.4%
37/72 • Number of events 71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
59.5%
44/74 • Number of events 80 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
39.1%
25/64 • Number of events 25 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
36.7%
22/60 • Number of events 22 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
23.8%
15/63 • Number of events 15 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
34.9%
22/63 • Number of events 22 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
25.4%
16/63 • Number of events 16 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
39.7%
25/63 • Number of events 25 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
44.4%
28/63 • Number of events 28 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
49.2%
32/65 • Number of events 32 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
45.2%
28/62 • Number of events 28 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
34.3%
23/67 • Number of events 23 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
35.3%
24/68 • Number of events 24 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
35.8%
24/67 • Number of events 24 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
General disorders
Pyrexia
|
61.1%
121/198 • Number of events 205 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
51.5%
102/198 • Number of events 165 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
61.8%
123/199 • Number of events 200 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
32.4%
23/71 • Number of events 35 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
38.9%
28/72 • Number of events 35 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
54.1%
40/74 • Number of events 68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
34.4%
22/64 • Number of events 22 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
35.0%
21/60 • Number of events 21 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
23.8%
15/63 • Number of events 15 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
30.2%
19/63 • Number of events 19 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
30.2%
19/63 • Number of events 19 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
31.7%
20/63 • Number of events 20 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
31.7%
20/63 • Number of events 20 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
35.4%
23/65 • Number of events 23 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
45.2%
28/62 • Number of events 28 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
31.3%
21/67 • Number of events 21 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
20.6%
14/68 • Number of events 14 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
26.9%
18/67 • Number of events 18 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
General disorders
Swelling
|
30.8%
61/198 • Number of events 96 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
25.8%
51/198 • Number of events 87 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
28.6%
57/199 • Number of events 89 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
28.2%
20/71 • Number of events 36 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
23.6%
17/72 • Number of events 30 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
25.7%
19/74 • Number of events 36 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
25.0%
16/64 • Number of events 16 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
26.7%
16/60 • Number of events 16 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
14.3%
9/63 • Number of events 9 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
25.4%
16/63 • Number of events 16 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
9.5%
6/63 • Number of events 6 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
17.5%
11/63 • Number of events 11 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
25.4%
16/63 • Number of events 16 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
27.7%
18/65 • Number of events 18 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
24.2%
15/62 • Number of events 15 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
25.4%
17/67 • Number of events 17 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
17.6%
12/68 • Number of events 12 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
23.9%
16/67 • Number of events 16 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
5/198 • Number of events 5 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.5%
3/198 • Number of events 3 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.5%
3/199 • Number of events 4 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/71 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
5.4%
4/74 • Number of events 4 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/64 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/60 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/63 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/65 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Infections and infestations
Pharyngitis
|
2.5%
5/198 • Number of events 6 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
2.5%
5/198 • Number of events 6 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
5.0%
10/199 • Number of events 14 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
4.2%
3/71 • Number of events 3 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/72 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
4.1%
3/74 • Number of events 4 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
3.3%
2/60 • Number of events 2 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.6%
1/63 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.6%
1/63 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
1.6%
1/63 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
3.2%
2/63 • Number of events 2 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
6.3%
4/63 • Number of events 5 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
3.1%
2/65 • Number of events 3 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/62 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/68 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
0.00%
0/67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.4%
84/198 • Number of events 145 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
49.5%
98/198 • Number of events 150 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
50.3%
100/199 • Number of events 160 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
35.2%
25/71 • Number of events 33 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
33.3%
24/72 • Number of events 39 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
56.8%
42/74 • Number of events 70 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
21.9%
14/64 • Number of events 14 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
26.7%
16/60 • Number of events 16 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
14.3%
9/63 • Number of events 9 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
19.0%
12/63 • Number of events 12 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
23.8%
15/63 • Number of events 15 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
30.2%
19/63 • Number of events 19 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
33.3%
21/63 • Number of events 21 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
36.9%
24/65 • Number of events 24 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
22.6%
14/62 • Number of events 14 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
13.4%
9/67 • Number of events 9 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
14.7%
10/68 • Number of events 10 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
25.4%
17/67 • Number of events 17 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Nervous system disorders
Somnolence
|
58.1%
115/198 • Number of events 197 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
56.1%
111/198 • Number of events 194 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
61.8%
123/199 • Number of events 209 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
56.3%
40/71 • Number of events 79 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
45.8%
33/72 • Number of events 51 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
60.8%
45/74 • Number of events 77 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
28.1%
18/64 • Number of events 18 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
30.0%
18/60 • Number of events 18 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
27.0%
17/63 • Number of events 17 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
30.2%
19/63 • Number of events 19 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
14.3%
9/63 • Number of events 9 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
33.3%
21/63 • Number of events 21 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
34.9%
22/63 • Number of events 22 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
36.9%
24/65 • Number of events 24 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
38.7%
24/62 • Number of events 24 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
17.9%
12/67 • Number of events 12 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
23.5%
16/68 • Number of events 16 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
28.4%
19/67 • Number of events 19 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Psychiatric disorders
Irritability
|
60.6%
120/198 • Number of events 244 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
61.1%
121/198 • Number of events 239 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
69.3%
138/199 • Number of events 275 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
57.7%
41/71 • Number of events 75 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
59.7%
43/72 • Number of events 86 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
79.7%
59/74 • Number of events 109 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
51.6%
33/64 • Number of events 33 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
45.0%
27/60 • Number of events 27 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
36.5%
23/63 • Number of events 23 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
34.9%
22/63 • Number of events 22 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
41.3%
26/63 • Number of events 26 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
42.9%
27/63 • Number of events 27 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
57.1%
36/63 • Number of events 36 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
50.8%
33/65 • Number of events 33 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
51.6%
32/62 • Number of events 32 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
38.8%
26/67 • Number of events 26 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
32.4%
22/68 • Number of events 22 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
40.3%
27/67 • Number of events 27 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
54.5%
108/198 • Number of events 217 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
44.9%
89/198 • Number of events 174 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
52.8%
105/199 • Number of events 205 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
50.7%
36/71 • Number of events 76 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
48.6%
35/72 • Number of events 67 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
62.2%
46/74 • Number of events 90 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
42.2%
27/64 • Number of events 27 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
41.7%
25/60 • Number of events 25 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
27.0%
17/63 • Number of events 17 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
36.5%
23/63 • Number of events 23 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
23.8%
15/63 • Number of events 15 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
34.9%
22/63 • Number of events 22 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
36.5%
23/63 • Number of events 23 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
38.5%
25/65 • Number of events 25 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
37.1%
23/62 • Number of events 23 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
34.3%
23/67 • Number of events 23 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
33.8%
23/68 • Number of events 23 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
34.3%
23/67 • Number of events 23 • Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER