Trial Outcomes & Findings for Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children (NCT NCT00228917)
NCT ID: NCT00228917
Last Updated: 2020-02-20
Results Overview
Among solicited general symptoms fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )\] was assessed, post vaccination. Grade 3 fever = fever \> 39.0 °C.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
798 participants
Primary outcome timeframe
During the 4-day (Day 0-3) follow-up period after booster vaccination
Results posted on
2020-02-20
Participant Flow
Participant milestones
| Measure |
ACAC_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Thailand Group
Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibACPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibHibPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
ACAC_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Philippines Group
Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibACPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibHibPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
193
|
96
|
65
|
33
|
205
|
104
|
69
|
33
|
|
Overall Study
COMPLETED
|
193
|
96
|
65
|
33
|
205
|
102
|
69
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
ACAC_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Thailand Group
Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibACPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibHibPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
ACAC_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Philippines Group
Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibACPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibHibPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Migrated/moved from study area
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
Baseline characteristics by cohort
| Measure |
ACAC_Thailand Group
n=193 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Thailand Group
n=96 Participants
Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibACPS_Thailand Group
n=65 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibHibPS_Thailand Group
n=33 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
ACAC_Philippines Group
n=205 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Philippines Group
n=104 Participants
Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibACPS_Philippines Group
n=69 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibHibPS_Philippines Group
n=33 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Total
n=798 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
17.7 Months
STANDARD_DEVIATION 0.7 • n=99 Participants
|
17.8 Months
STANDARD_DEVIATION 0.71 • n=107 Participants
|
17.7 Months
STANDARD_DEVIATION 0.78 • n=206 Participants
|
17.6 Months
STANDARD_DEVIATION 0.7 • n=7 Participants
|
17.1 Months
STANDARD_DEVIATION 0.78 • n=31 Participants
|
17.2 Months
STANDARD_DEVIATION 0.79 • n=30 Participants
|
17.2 Months
STANDARD_DEVIATION 0.93 • n=3 Participants
|
17 Months
STANDARD_DEVIATION 0.77 • n=6 Participants
|
17.59 Months
STANDARD_DEVIATION 0.76 • n=114 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
107 Participants
n=31 Participants
|
56 Participants
n=30 Participants
|
29 Participants
n=3 Participants
|
16 Participants
n=6 Participants
|
399 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
98 Participants
n=31 Participants
|
48 Participants
n=30 Participants
|
40 Participants
n=3 Participants
|
17 Participants
n=6 Participants
|
399 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: During the 4-day (Day 0-3) follow-up period after booster vaccinationPopulation: This analysis was performed on Booster Total Vaccinated cohort which included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.
Among solicited general symptoms fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )\] was assessed, post vaccination. Grade 3 fever = fever \> 39.0 °C.
Outcome measures
| Measure |
ACAC_Thailand Group
n=193 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Thailand Group
n=96 Participants
Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibACPS_Thailand Group
n=65 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibHibPS_Thailand Group
n=33 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
ACAC_Philippines Group
n=205 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Philippines Group
n=102 Participants
Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibACPS_Philippines Group
n=69 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibHibPS_Philippines Group
n=33 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Fever >39°C (Rectal Route).
|
22 Participants
|
8 Participants
|
5 Participants
|
3 Participants
|
40 Participants
|
24 Participants
|
17 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) follow-up period after vaccinationPopulation: This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
ACAC_Thailand Group
n=193 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Thailand Group
n=96 Participants
Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibACPS_Thailand Group
n=65 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibHibPS_Thailand Group
n=33 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
ACAC_Philippines Group
n=205 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Philippines Group
n=102 Participants
Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibACPS_Philippines Group
n=69 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibHibPS_Philippines Group
n=33 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Fever ≥ 38.5°C
|
55 Participants
|
24 Participants
|
19 Participants
|
7 Participants
|
80 Participants
|
41 Participants
|
35 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Related Drowsiness
|
110 Participants
|
63 Participants
|
41 Participants
|
17 Participants
|
16 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Related Irritability
|
146 Participants
|
74 Participants
|
53 Participants
|
26 Participants
|
29 Participants
|
15 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Any Loss of appetite
|
98 Participants
|
46 Participants
|
33 Participants
|
15 Participants
|
72 Participants
|
40 Participants
|
24 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Related Loss of appetite
|
96 Participants
|
46 Participants
|
33 Participants
|
15 Participants
|
18 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Fever ≥ 40.0°C
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Related Fever
|
112 Participants
|
57 Participants
|
47 Participants
|
18 Participants
|
34 Participants
|
21 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Any Drowsiness
|
113 Participants
|
63 Participants
|
41 Participants
|
17 Participants
|
53 Participants
|
33 Participants
|
23 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Grade 3 Drowsiness
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Any Irritability
|
149 Participants
|
75 Participants
|
53 Participants
|
26 Participants
|
116 Participants
|
59 Participants
|
39 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Grade 3 Irritability
|
21 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Grade 3 Loss of appetite
|
7 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) follow-up period after booster vaccinationPopulation: This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Outcome measures
| Measure |
ACAC_Thailand Group
n=193 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Thailand Group
n=96 Participants
Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibACPS_Thailand Group
n=65 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibHibPS_Thailand Group
n=33 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
ACAC_Philippines Group
n=205 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Philippines Group
n=102 Participants
Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibACPS_Philippines Group
n=69 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibHibPS_Philippines Group
n=33 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Pain
|
168 Subjects
|
78 Subjects
|
55 Subjects
|
26 Subjects
|
151 Subjects
|
69 Subjects
|
49 Subjects
|
22 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Pain
|
57 Subjects
|
14 Subjects
|
12 Subjects
|
4 Subjects
|
42 Subjects
|
13 Subjects
|
22 Subjects
|
8 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Redness
|
12 Subjects
|
0 Subjects
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Swelling
|
95 Subjects
|
33 Subjects
|
33 Subjects
|
14 Subjects
|
51 Subjects
|
32 Subjects
|
21 Subjects
|
10 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Redness
|
99 Subjects
|
33 Subjects
|
33 Subjects
|
16 Subjects
|
40 Subjects
|
33 Subjects
|
21 Subjects
|
9 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Swelling
|
18 Subjects
|
5 Subjects
|
8 Subjects
|
1 Subjects
|
10 Subjects
|
6 Subjects
|
3 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the 31-day (Day 0-30) following booster vaccinationPopulation: This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
ACAC_Thailand Group
n=193 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Thailand Group
n=96 Participants
Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibACPS_Thailand Group
n=65 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibHibPS_Thailand Group
n=33 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
ACAC_Philippines Group
n=205 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Philippines Group
n=102 Participants
Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibACPS_Philippines Group
n=69 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibHibPS_Philippines Group
n=33 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs).
|
64 Subjects
|
23 Subjects
|
24 Subjects
|
9 Subjects
|
53 Subjects
|
33 Subjects
|
16 Subjects
|
6 Subjects
|
SECONDARY outcome
Timeframe: From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccinationPopulation: This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
ACAC_Thailand Group
n=193 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Thailand Group
n=96 Participants
Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibACPS_Thailand Group
n=65 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
HibHibPS_Thailand Group
n=33 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
ACAC_Philippines Group
n=205 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
|
ACHibPS_Philippines Group
n=102 Participants
Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibACPS_Philippines Group
n=69 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
HibHibPS_Philippines Group
n=33 Participants
Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs).
|
3 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
Adverse Events
ACAC Group
Serious events: 5 serious events
Other events: 376 other events
Deaths: 0 deaths
ACHibPS Group
Serious events: 1 serious events
Other events: 181 other events
Deaths: 0 deaths
HibACPS Group
Serious events: 0 serious events
Other events: 129 other events
Deaths: 0 deaths
HibHibPS Group
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACAC Group
n=398 participants at risk
Subjects from both ACAC\_Thailand and ACAC\_Philippines groups
|
ACHibPS Group
n=200 participants at risk
Subjects from both ACHibPS\_Thailand and ACHibPS\_Philippines groups
|
HibACPS Group
n=134 participants at risk
Subjects from both HibACPS\_Thailand and HibACPS\_Philippines groups
|
HibHibPS Group
n=66 participants at risk
Subjects from both HibHibPS \_Thailand and HibHibPS \_Philippines groups
|
|---|---|---|---|---|
|
Nervous system disorders
Febrile convulsion
|
0.50%
2/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.50%
1/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
Gastrointestinal disorders
Diarrhoea
|
0.25%
1/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
Infections and infestations
Pharyngitis
|
0.25%
1/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
Infections and infestations
Measles
|
0.00%
0/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.50%
1/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
Infections and infestations
Upper respiratory tract infection
|
0.25%
1/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
Infections and infestations
Pneumonia
|
0.25%
1/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
0.00%
0/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
Other adverse events
| Measure |
ACAC Group
n=398 participants at risk
Subjects from both ACAC\_Thailand and ACAC\_Philippines groups
|
ACHibPS Group
n=200 participants at risk
Subjects from both ACHibPS\_Thailand and ACHibPS\_Philippines groups
|
HibACPS Group
n=134 participants at risk
Subjects from both HibACPS\_Thailand and HibACPS\_Philippines groups
|
HibHibPS Group
n=66 participants at risk
Subjects from both HibHibPS \_Thailand and HibHibPS \_Philippines groups
|
|---|---|---|---|---|
|
General disorders
Pain
|
80.2%
319/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
73.5%
147/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
77.6%
104/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
72.7%
48/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
General disorders
Swelling
|
36.7%
146/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
32.5%
65/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
40.3%
54/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
36.4%
24/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
General disorders
Pyrexia
|
68.3%
272/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
63.0%
126/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
73.9%
99/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
62.1%
41/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
Infections and infestations
Upper respiratory tract infection
|
9.0%
36/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
8.0%
16/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
6.7%
9/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
6.1%
4/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
Psychiatric disorders
Irritability
|
66.6%
265/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
67.0%
134/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
68.7%
92/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
65.2%
43/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.7%
170/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
43.0%
86/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
42.5%
57/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
31.8%
21/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
Skin and subcutaneous tissue disorders
Erythema
|
34.9%
139/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
33.0%
66/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
40.3%
54/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
37.9%
25/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
10/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
2.0%
4/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
6.0%
8/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
3.0%
2/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
|
Nervous system disorders
Somnolence
|
41.7%
166/398 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
48.0%
96/200 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
47.8%
64/134 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
37.9%
25/66 • Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
|
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