Trial Outcomes & Findings for Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen (NCT NCT00436007)
NCT ID: NCT00436007
Last Updated: 2018-08-16
Results Overview
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
511 participants
Primary outcome timeframe
From Month 0 to Month 8
Results posted on
2018-08-16
Participant Flow
The study comprised a vaccination phase (Months 0-8) and a follow-up phase (Months 8-19). The Stamaril™ vaccine was not part of the EPI Tanzanian vaccination schedule at study planning. Hence this vaccine was not administered to subjects from Tanzania.
Participant milestones
| Measure |
GSK 257049 1 Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Overall Study
STARTED
|
170
|
170
|
171
|
|
Overall Study
COMPLETED
|
151
|
156
|
148
|
|
Overall Study
NOT COMPLETED
|
19
|
14
|
23
|
Reasons for withdrawal
| Measure |
GSK 257049 1 Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
14
|
10
|
13
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
3
|
|
Overall Study
Other
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen
Baseline characteristics by cohort
| Measure |
GSK 257049 1 Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=171 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Total
n=511 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
7.0 Weeks
STANDARD_DEVIATION 0.97 • n=99 Participants
|
7.1 Weeks
STANDARD_DEVIATION 1.05 • n=107 Participants
|
7.0 Weeks
STANDARD_DEVIATION 0.97 • n=206 Participants
|
7.0 Weeks
STANDARD_DEVIATION 1.00 • n=157 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
252 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
259 Participants
n=157 Participants
|
|
Region of Enrollment
Gabon
|
73 Subjects
n=99 Participants
|
73 Subjects
n=107 Participants
|
74 Subjects
n=206 Participants
|
220 Subjects
n=157 Participants
|
|
Region of Enrollment
Ghana
|
27 Subjects
n=99 Participants
|
27 Subjects
n=107 Participants
|
27 Subjects
n=206 Participants
|
81 Subjects
n=157 Participants
|
|
Region of Enrollment
Tanzania
|
70 Subjects
n=99 Participants
|
70 Subjects
n=107 Participants
|
70 Subjects
n=206 Participants
|
210 Subjects
n=157 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 8Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
n=171 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs).
|
33 subjects
|
38 subjects
|
28 subjects
|
SECONDARY outcome
Timeframe: At Months 0, 1, 3 and 7.Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 1 Group.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=145 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Anti-HB, Month 0 [N=145]
|
—
|
12.5 mIU/mL
Interval 9.9 to 15.7
|
—
|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Anti-HB, Month 1 [N=133]
|
—
|
173.4 mIU/mL
Interval 131.9 to 228.0
|
—
|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Anti-HB, Month 3 [N=130]
|
—
|
1355.7 mIU/mL
Interval 1100.6 to 1669.9
|
—
|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Anti-HB, Month 7 [N=137]
|
—
|
1555.5 mIU/mL
Interval 1315.8 to 1839.0
|
—
|
SECONDARY outcome
Timeframe: At Months 0, 3, 7 and 8.Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 2 Group.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=131 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Anti-HB, Month 0 [N=131]
|
—
|
9.6 mIU/mL
Interval 7.8 to 11.8
|
—
|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Anti-HB, Month 3 [N=119]
|
—
|
651.2 mIU/mL
Interval 541.1 to 783.8
|
—
|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Anti-HB, Month 7 [N=126]
|
—
|
1133.1 mIU/mL
Interval 972.3 to 1320.6
|
—
|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Anti-HB, Month 8 [N=125]
|
—
|
59813.5 mIU/mL
Interval 47050.5 to 76038.6
|
—
|
SECONDARY outcome
Timeframe: At Months 0, 3, 7 and 8.Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=143 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Anti-HB, Month 0 [N=143]
|
—
|
8.7 mIU/mL
Interval 7.3 to 10.5
|
—
|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Anti-HB, Month 3 [N=126]
|
—
|
338.0 mIU/mL
Interval 266.3 to 429.0
|
—
|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Anti-HB, Month 7 [N=131]
|
—
|
159.9 mIU/mL
Interval 127.0 to 201.3
|
—
|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Anti-HB, Month 8 [N=133]
|
—
|
162.4 mIU/mL
Interval 127.9 to 206.3
|
—
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Anti-D and Anti-T antibody concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection assay cut-off was 0.1 IU/mL.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
n=142 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=142 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=133 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Concentrations of Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-D
|
1.4 IU/mL
Interval 1.2 to 1.7
|
1.0 IU/mL
Interval 0.9 to 1.2
|
1.1 IU/mL
Interval 0.9 to 1.3
|
|
Concentrations of Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-T
|
3.7 IU/mL
Interval 3.2 to 4.3
|
2.8 IU/mL
Interval 2.3 to 3.3
|
2.6 IU/mL
Interval 2.2 to 3.1
|
SECONDARY outcome
Timeframe: From Month 8 to Month 19Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
n=171 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs).
|
27 subjects
|
28 subjects
|
24 subjects
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Anti-PRP antibody concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection assay cut-off was 0.15 µg/mL.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
n=142 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=141 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=132 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Concentrations of Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibodies.
|
18.6 µg/mL
Interval 14.8 to 23.5
|
13.3 µg/mL
Interval 10.5 to 16.7
|
15.7 µg/mL
Interval 12.6 to 19.4
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Anti-Polio 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 8.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
n=133 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=136 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=125 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Titers for Antibodies Against Poliomyelitis Types 1, 2 and 3 (Anti-Polio 1, 2 and 3 Antibodies).
Anti-Polio 1 [N=136;125;131]
|
500.0 titers
Interval 365.0 to 684.9
|
463.6 titers
Interval 342.8 to 627.0
|
485.5 titers
Interval 342.5 to 688.3
|
|
Titers for Antibodies Against Poliomyelitis Types 1, 2 and 3 (Anti-Polio 1, 2 and 3 Antibodies).
Anti-Polio 2 [N=135;124;131]
|
406.8 titers
Interval 329.1 to 502.9
|
494.0 titers
Interval 389.7 to 626.2
|
563.2 titers
Interval 457.3 to 693.6
|
|
Titers for Antibodies Against Poliomyelitis Types 1, 2 and 3 (Anti-Polio 1, 2 and 3 Antibodies).
Anti-Polio 3 [N=135;125;133]
|
205.1 titers
Interval 156.5 to 268.7
|
123.5 titers
Interval 92.1 to 165.6
|
148.7 titers
Interval 112.2 to 197.0
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Anti-BPT antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 15 EL.U/mL.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
n=139 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=139 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=131 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Concentrations of Anti-Bordetella Pertussis Toxin (Anti-BPT) Antibodies.
|
106.5 EL.U/mL
Interval 96.1 to 118.1
|
85.3 EL.U/mL
Interval 76.8 to 94.6
|
104.4 EL.U/mL
Interval 94.8 to 115.0
|
SECONDARY outcome
Timeframe: At Months 7 and 8.Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Anti-measles antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seropositivity assay cut-off was 150 mIU/mL. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=119 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=122 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Concentrations of Anti-measles Antibodies.
Anti-measles, Month 7 [N=112;120]
|
—
|
75.0 mIU/mL
Interval 75.0 to 75.0
|
1295.2 mIU/mL
Interval 1052.1 to 1594.5
|
|
Concentrations of Anti-measles Antibodies.
Anti-measles, Month 8 [N=119;122]
|
—
|
76.2 mIU/mL
Interval 73.8 to 78.6
|
1299.0 mIU/mL
Interval 1038.8 to 1624.4
|
SECONDARY outcome
Timeframe: At Months 7 and 8.Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Anti-yellow fever antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 10. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=62 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=64 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Titers for Anti-yellow Fever Antibodies.
Anti-yellow fever, Month 7 [N=41;62]
|
—
|
5.3 titers
Interval 4.8 to 5.8
|
5.9 titers
Interval 5.1 to 6.9
|
|
Titers for Anti-yellow Fever Antibodies.
Anti-yellow fever, Month 8 [N=46;64]
|
—
|
172.2 titers
Interval 135.9 to 236.3
|
183.4 titers
Interval 134.0 to 250.9
|
SECONDARY outcome
Timeframe: At Months 0, 1, 3 and 7.Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Anti-CS antibody antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 1 Group.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=153 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Anti-CS, Month 0 [N=153]
|
—
|
0.4 EL.U/mL
Interval 0.3 to 0.4
|
—
|
|
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Anti-CS, Month 2 [N=137]
|
—
|
86.6 EL.U/mL
Interval 66.5 to 112.7
|
—
|
|
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Anti-CS, Month 3 [N=131]
|
—
|
190.3 EL.U/mL
Interval 154.3 to 234.7
|
—
|
|
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Anti-CS, Month 7 [N=137]
|
—
|
35.3 EL.U/mL
Interval 28.5 to 43.8
|
—
|
SECONDARY outcome
Timeframe: At Months 0, 3, 7 and 8.Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Anti-CS antiibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 2 Group.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=141 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Anti-CS, Month 0 [N=141]
|
—
|
0.4 EL.U/mL
Interval 0.3 to 0.4
|
—
|
|
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Anti-CS, Month 3 [N=121]
|
—
|
57.7 EL.U/mL
Interval 43.7 to 76.2
|
—
|
|
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Anti-CS, Month 7 [N=127]
|
—
|
6.1 EL.U/mL
Interval 4.6 to 7.9
|
—
|
|
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Anti-CS, Month 8 [N=127]
|
—
|
107.8 EL.U/mL
Interval 81.1 to 143.4
|
—
|
SECONDARY outcome
Timeframe: At Months 0, 3, 7 and 8.Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Anti-CS antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=156 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Anti-CS, Month 0 [N=156]
|
—
|
0.4 EL.U/mL
Interval 0.3 to 0.4
|
—
|
|
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Anti-CS, Month 3 [N=129]
|
—
|
0.3 EL.U/mL
Interval 0.3 to 0.3
|
—
|
|
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Anti-CS, Month 7 [N=132]
|
—
|
0.3 EL.U/mL
Interval 0.3 to 0.3
|
—
|
|
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Anti-CS, Month 8 [N=135]
|
—
|
0.3 EL.U/mL
Interval 0.3 to 0.3
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination with the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines.Population: The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed.
Assessed solicited local symptoms were pain and swelling at injection site following vaccination with each of the following study vaccines administered intramuscularly, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines. The numbers of subjects with each of the assessed solicited local symptoms reported were tabulated for each vaccine administered, separately.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
n=171 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms.
Pain - Stamaril™ [N=95;94;94]
|
2 subjects
|
2 subjects
|
7 subjects
|
|
Number of Subjects With Solicited Local Symptoms.
Swelling - Stamaril™ [N=95;94;94]
|
0 subjects
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Solicited Local Symptoms.
Pain - Tritanrix™ HepB/Hib [N=170;170;171]
|
140 subjects
|
127 subjects
|
133 subjects
|
|
Number of Subjects With Solicited Local Symptoms.
Pain - GSK 257049 [N=170;170;0]
|
NA subjects
The GSK 257049 vaccine was not administered to subjects from the Tritanrix™ HepB/Hiberix™ Group group.
|
126 subjects
|
116 subjects
|
|
Number of Subjects With Solicited Local Symptoms.
Swelling - GSK 257049 [N=170;170;0]
|
NA subjects
The GSK 257049 vaccine was not administered to subjects from the Tritanrix™ HepB/Hiberix™ Group group.
|
28 subjects
|
44 subjects
|
|
Number of Subjects With Solicited Local Symptoms.
Pain - Rouvax™ [N=163;161;159]
|
47 subjects
|
52 subjects
|
54 subjects
|
|
Number of Subjects With Solicited Local Symptoms.
Swelling - Rouvax™ [N=163;161;159]
|
16 subjects
|
20 subjects
|
21 subjects
|
|
Number of Subjects With Solicited Local Symptoms.
Swelling - Tritanrix™ HepB/Hib [N=170;170;171]
|
68 subjects
|
47 subjects
|
68 subjects
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccinationPopulation: The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed.
Assessed solicited general symptoms were drowsiness, fever \[axillary temperature equal or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite following any vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
n=171 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms.
Drowsiness
|
72 subjects
|
82 subjects
|
97 subjects
|
|
Number of Subjects With Solicited General Symptoms.
Fever (axillary temperature ≥ 37.5°C)
|
75 subjects
|
102 subjects
|
95 subjects
|
|
Number of Subjects With Solicited General Symptoms.
Irritability
|
118 subjects
|
124 subjects
|
131 subjects
|
|
Number of Subjects With Solicited General Symptoms.
Loss of appetite
|
70 subjects
|
68 subjects
|
83 subjects
|
SECONDARY outcome
Timeframe: During the 30-day (Days 0-29) follow-up period after any vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
An unsolicited AE is any AE (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. Unsolicited AEs were assessed following vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
n=171 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
164 subjects
|
160 subjects
|
161 subjects
|
SECONDARY outcome
Timeframe: From Month 0 to Month 19Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Outcome measures
| Measure |
Tritanrix™ HepB/Hiberix™ Group
n=171 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=170 Participants
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs).
|
49 subjects
|
57 subjects
|
47 subjects
|
Adverse Events
GSK 257049 1 Group
Serious events: 57 serious events
Other events: 169 other events
Deaths: 0 deaths
GSK 257049 2 Group
Serious events: 47 serious events
Other events: 169 other events
Deaths: 0 deaths
Tritanrix™ HepB/Hiberix™ Group
Serious events: 49 serious events
Other events: 171 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK 257049 1 Group
n=170 participants at risk
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=170 participants at risk
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=171 participants at risk
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
4.1%
7/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
3.5%
6/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
1.2%
2/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Plasmodium falciparum infection
|
3.5%
6/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
3.5%
6/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
8.2%
14/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Pneumonia
|
2.9%
5/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
4.1%
7/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
4.1%
7/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
6/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
3.5%
6/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
5.8%
10/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
7/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
2.4%
4/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
2.9%
5/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Impetigo
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
1.8%
3/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
1.8%
3/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Sepsis
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
1.2%
2/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
1.2%
2/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
3/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Otitis media
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Gastrointestinal disorders
Enteritis
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
1.2%
2/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
1.2%
2/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Bronchitis
|
1.8%
3/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
1.2%
2/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Bronchopneumonia
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Salmonella sepsis
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Acquired immunodeficiency syndrome
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Eye disorders
Blepharitis
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Congenital, familial and genetic disorders
Cataract congenital
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Nervous system disorders
Convulsion
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Extrapulmonary tuberculosis
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Hydrocele male infected
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.2%
2/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Periorbital abscess
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
General disorders
Pyrexia
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Skin infection
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
1.2%
2/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.2%
2/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Dysentery
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Injury, poisoning and procedural complications
Petroleum distillate poisoning
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Injury, poisoning and procedural complications
Pneumonitis chemical
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Pyelonephritis
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.59%
1/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.00%
0/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
0.58%
1/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
Other adverse events
| Measure |
GSK 257049 1 Group
n=170 participants at risk
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
GSK 257049 2 Group
n=170 participants at risk
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
Tritanrix™ HepB/Hiberix™ Group
n=171 participants at risk
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
|
|---|---|---|---|
|
General disorders
Drowsiness
|
48.2%
82/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
57.1%
97/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
42.1%
72/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
General disorders
Fever
|
60.0%
102/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
55.9%
95/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
43.9%
75/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
General disorders
Irritability
|
72.9%
124/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
77.1%
131/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
69.0%
118/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
General disorders
Loss of appetite
|
40.0%
68/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
48.8%
83/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
40.9%
70/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
General disorders
Pain
|
2.1%
2/95 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
7.4%
7/94 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
2.1%
2/94 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
General disorders
Swelling
|
16.5%
28/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
25.9%
44/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
—
0/0 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Upper respiratory tract infection
|
38.8%
66/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
38.8%
66/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
38.0%
65/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Nasopharyngitis
|
31.2%
53/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
36.5%
62/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
41.5%
71/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Gastroenteritis
|
17.1%
29/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
14.7%
25/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
18.7%
32/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Rhinitis
|
9.4%
16/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
12.4%
21/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
12.3%
21/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.4%
21/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
17.6%
30/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
14.0%
24/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
General disorders
Induration
|
15.3%
26/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
16.5%
28/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
17.0%
29/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.4%
21/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
14.1%
24/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
14.0%
24/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.2%
19/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
11.2%
19/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
13.5%
23/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Pneumonia
|
11.2%
19/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
6.5%
11/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
5.3%
9/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Eye disorders
Conjunctivitis
|
9.4%
16/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
12.4%
21/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
11.1%
19/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Infections and infestations
Bronchitis
|
10.0%
17/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
10.0%
17/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
12.3%
21/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
11/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
11.2%
19/170 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
6.4%
11/171 • SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
|
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