Trial Outcomes & Findings for Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age. (NCT NCT00829010)
NCT ID: NCT00829010
Last Updated: 2018-08-17
Results Overview
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
489 participants
Primary outcome timeframe
1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (3+0) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group)
Results posted on
2018-08-17
Participant Flow
The oral poliovirus vaccine could be given at any time during the study (routinely given concurrently with Tritanrix™-HepB/Hib vaccine) but was not considered as study vaccine. Out of the 489 subjects enrolled in the study, 484 subjects were assigned to a study group and received vaccination.
The study included 3 populations defined based on the human immunodeficiency virus status of the mother and the infant. Infant born from: * a HIV positive mother and HIV infected at Month 0 = HIV+/+. * a HIV positive mother and HIV exposed uninfected at screening = HIV+/-. * a HIV negative mother and HIV unexposed uninfected at Month 0 = HIV-
Participant milestones
| Measure |
HIV+/+ Group
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
83
|
101
|
100
|
100
|
100
|
|
Overall Study
COMPLETED
|
73
|
92
|
97
|
92
|
98
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
3
|
8
|
2
|
Reasons for withdrawal
| Measure |
HIV+/+ Group
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
0
|
0
|
|
Overall Study
Fatality
|
5
|
4
|
0
|
3
|
0
|
|
Overall Study
Migrated/Moved from study area
|
3
|
4
|
0
|
5
|
0
|
Baseline Characteristics
Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.
Baseline characteristics by cohort
| Measure |
HIV+/+ Group
n=83 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=101 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=100 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=100 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=100 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
Total
n=484 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
6.6 Weeks
STANDARD_DEVIATION 0.92 • n=5 Participants
|
6.3 Weeks
STANDARD_DEVIATION 0.65 • n=7 Participants
|
6.1 Weeks
STANDARD_DEVIATION 0.41 • n=5 Participants
|
6.1 Weeks
STANDARD_DEVIATION 0.35 • n=4 Participants
|
6.1 Weeks
STANDARD_DEVIATION 0.29 • n=21 Participants
|
6.2 Weeks
STANDARD_DEVIATION 0.59 • n=10 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
251 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
233 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (3+0) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group)Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Outcome measures
| Measure |
HIV+/+ Group
n=70 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=91 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=93 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=94 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=97 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Anti-5
|
70 Participants
|
90 Participants
|
93 Participants
|
94 Participants
|
95 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Anti-6B
|
61 Participants
|
80 Participants
|
74 Participants
|
83 Participants
|
80 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Anti-7F
|
69 Participants
|
90 Participants
|
93 Participants
|
94 Participants
|
96 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Anti-1
|
69 Participants
|
90 Participants
|
93 Participants
|
94 Participants
|
96 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Anti-4
|
69 Participants
|
90 Participants
|
93 Participants
|
93 Participants
|
96 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Anti-9V
|
68 Participants
|
90 Participants
|
93 Participants
|
94 Participants
|
92 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Anti-14
|
69 Participants
|
90 Participants
|
93 Participants
|
93 Participants
|
95 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Anti-18C
|
69 Participants
|
90 Participants
|
93 Participants
|
94 Participants
|
95 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Anti-19F
|
68 Participants
|
90 Participants
|
93 Participants
|
93 Participants
|
94 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Anti-23F
|
63 Participants
|
84 Participants
|
83 Participants
|
84 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: At Month 3 and Month 9Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups, post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL.
Outcome measures
| Measure |
HIV+/+ Group
n=70 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=91 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=93 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=94 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=97 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-5 [Month 3]
|
4.99 µg/ml
Interval 4.0 to 6.23
|
4.79 µg/ml
Interval 3.96 to 5.79
|
4.41 µg/ml
Interval 3.79 to 5.13
|
5.71 µg/ml
Interval 4.84 to 6.75
|
3.45 µg/ml
Interval 2.85 to 4.16
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-1 [Month 3]
|
4.00 µg/ml
Interval 3.3 to 4.84
|
3.85 µg/ml
Interval 3.26 to 4.55
|
3.36 µg/ml
Interval 2.91 to 3.88
|
4.65 µg/ml
Interval 3.91 to 5.53
|
3.33 µg/ml
Interval 2.85 to 3.88
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-1 [Month 9]
|
6.64 µg/ml
Interval 5.22 to 8.46
|
8.64 µg/ml
Interval 7.09 to 10.53
|
5.38 µg/ml
Interval 4.47 to 6.48
|
0.72 µg/ml
Interval 0.58 to 0.88
|
5.14 µg/ml
Interval 4.42 to 5.97
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-4 [Month 3]
|
3.67 µg/ml
Interval 2.81 to 4.8
|
3.14 µg/ml
Interval 2.6 to 3.8
|
2.71 µg/ml
Interval 2.28 to 3.21
|
3.77 µg/ml
Interval 3.09 to 4.6
|
2.28 µg/ml
Interval 1.9 to 2.75
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-4 [Month 9]
|
6.97 µg/ml
Interval 5.72 to 8.5
|
8.04 µg/ml
Interval 6.69 to 9.68
|
6.07 µg/ml
Interval 5.09 to 7.24
|
1.07 µg/ml
Interval 0.86 to 1.34
|
4.92 µg/ml
Interval 4.16 to 5.81
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-5 [Month 9]
|
7.86 µg/ml
Interval 6.25 to 9.89
|
9.48 µg/ml
Interval 7.84 to 11.46
|
8.05 µg/ml
Interval 6.7 to 9.66
|
1.44 µg/ml
Interval 1.16 to 1.77
|
6.96 µg/ml
Interval 5.89 to 8.22
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-6B [Month 3]
|
1.00 µg/ml
Interval 0.73 to 1.38
|
0.94 µg/ml
Interval 0.71 to 1.24
|
0.65 µg/ml
Interval 0.5 to 0.86
|
1.06 µg/ml
Interval 0.81 to 1.39
|
0.57 µg/ml
Interval 0.45 to 0.73
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-7F [Month 3]
|
4.95 µg/ml
Interval 3.82 to 6.41
|
3.69 µg/ml
Interval 3.08 to 4.41
|
3.62 µg/ml
Interval 3.12 to 4.19
|
4.77 µg/ml
Interval 4.06 to 5.6
|
2.72 µg/ml
Interval 2.3 to 3.22
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-7F [Month 9]
|
9.92 µg/ml
Interval 7.89 to 12.47
|
11.04 µg/ml
Interval 9.29 to 13.11
|
8.98 µg/ml
Interval 7.63 to 10.56
|
1.78 µg/ml
Interval 1.49 to 2.13
|
6.47 µg/ml
Interval 5.59 to 7.5
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-9V [Month 3]
|
4.53 µg/ml
Interval 3.39 to 6.05
|
4.25 µg/ml
Interval 3.49 to 5.16
|
3.04 µg/ml
Interval 2.51 to 3.69
|
5.13 µg/ml
Interval 4.35 to 6.04
|
2.05 µg/ml
Interval 1.61 to 2.61
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-9V [Month 9]
|
10.09 µg/ml
Interval 7.64 to 13.32
|
10.89 µg/ml
Interval 9.11 to 13.03
|
9.55 µg/ml
Interval 8.06 to 11.31
|
1.96 µg/ml
Interval 1.58 to 2.43
|
6.51 µg/ml
Interval 5.12 to 8.3
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-14 [Month 3]
|
7.25 µg/ml
Interval 5.37 to 9.81
|
6.77 µg/ml
Interval 5.43 to 8.44
|
3.85 µg/ml
Interval 3.18 to 4.68
|
5.27 µg/ml
Interval 4.31 to 6.45
|
2.51 µg/ml
Interval 1.98 to 3.19
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-14 [Month 9]
|
11.50 µg/ml
Interval 9.17 to 14.41
|
10.58 µg/ml
Interval 8.6 to 13.0
|
7.33 µg/ml
Interval 5.94 to 9.04
|
2.60 µg/ml
Interval 2.01 to 3.37
|
5.08 µg/ml
Interval 4.03 to 6.41
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-18C [Month 3]
|
9.55 µg/ml
Interval 7.19 to 12.67
|
9.48 µg/ml
Interval 7.41 to 12.13
|
10.08 µg/ml
Interval 8.25 to 12.31
|
13.20 µg/ml
Interval 10.31 to 16.9
|
8.65 µg/ml
Interval 6.44 to 11.6
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-18C [Month 9]
|
20.26 µg/ml
Interval 16.13 to 25.45
|
19.67 µg/ml
Interval 15.89 to 24.35
|
25.47 µg/ml
Interval 21.75 to 29.83
|
3.30 µg/ml
Interval 2.55 to 4.27
|
32.29 µg/ml
Interval 26.43 to 39.45
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-19F [Month 3]
|
5.70 µg/ml
Interval 4.06 to 8.02
|
11.15 µg/ml
Interval 8.88 to 13.99
|
8.75 µg/ml
Interval 7.37 to 10.38
|
10.93 µg/ml
Interval 9.2 to 12.99
|
6.90 µg/ml
Interval 5.62 to 8.48
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-19F [Month 9]
|
8.00 µg/ml
Interval 5.86 to 10.92
|
12.46 µg/ml
Interval 10.47 to 14.84
|
8.88 µg/ml
Interval 7.37 to 10.69
|
2.60 µg/ml
Interval 2.03 to 3.31
|
9.47 µg/ml
Interval 7.42 to 12.07
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-23F [Month 3]
|
1.71 µg/ml
Interval 1.23 to 2.37
|
1.52 µg/ml
Interval 1.14 to 2.01
|
0.92 µg/ml
Interval 0.72 to 1.19
|
1.59 µg/ml
Interval 1.21 to 2.09
|
0.97 µg/ml
Interval 0.74 to 1.27
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-6B [Month 9]
|
2.26 µg/ml
Interval 1.72 to 2.98
|
2.56 µg/ml
Interval 2.01 to 3.25
|
2.05 µg/ml
Interval 1.57 to 2.68
|
0.93 µg/ml
Interval 0.75 to 1.15
|
1.98 µg/ml
Interval 1.62 to 2.42
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-23F [Month 9]
|
4.00 µg/ml
Interval 2.69 to 5.93
|
5.90 µg/ml
Interval 4.37 to 7.96
|
3.83 µg/ml
Interval 2.84 to 5.15
|
0.92 µg/ml
Interval 0.68 to 1.23
|
3.40 µg/ml
Interval 2.67 to 4.33
|
SECONDARY outcome
Timeframe: up to study end at Month 23 (24-27 months of age)Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. The cut-off of the assay is 0.05 µg/mL.
Outcome measures
| Measure |
HIV+/+ Group
n=63 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=86 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=92 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=91 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=97 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-1
|
0.53 µg/mL
Interval 0.35 to 0.8
|
0.74 µg/mL
Interval 0.57 to 0.95
|
0.42 µg/mL
Interval 0.34 to 0.53
|
0.28 µg/mL
Interval 0.22 to 0.37
|
0.33 µg/mL
Interval 0.26 to 0.41
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-4
|
0.56 µg/mL
Interval 0.38 to 0.8
|
0.57 µg/mL
Interval 0.46 to 0.71
|
0.44 µg/mL
Interval 0.35 to 0.57
|
0.33 µg/mL
Interval 0.25 to 0.44
|
0.34 µg/mL
Interval 0.27 to 0.43
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-5
|
0.79 µg/mL
Interval 0.55 to 1.15
|
0.77 µg/mL
Interval 0.61 to 0.97
|
0.72 µg/mL
Interval 0.57 to 0.92
|
0.45 µg/mL
Interval 0.36 to 0.57
|
0.52 µg/mL
Interval 0.43 to 0.64
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-7F
|
1.25 µg/mL
Interval 0.9 to 1.75
|
1.16 µg/mL
Interval 0.96 to 1.39
|
1.08 µg/mL
Interval 0.92 to 1.27
|
0.67 µg/mL
Interval 0.54 to 0.83
|
0.84 µg/mL
Interval 0.7 to 1.0
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-14
|
2.62 µg/mL
Interval 2.02 to 3.4
|
2.09 µg/mL
Interval 1.69 to 2.58
|
1.32 µg/mL
Interval 1.07 to 1.64
|
1.24 µg/mL
Interval 0.96 to 1.61
|
1.06 µg/mL
Interval 0.83 to 1.36
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-18C
|
2.02 µg/mL
Interval 1.41 to 2.89
|
1.60 µg/mL
Interval 1.22 to 2.09
|
1.93 µg/mL
Interval 1.58 to 2.35
|
0.80 µg/mL
Interval 0.63 to 1.01
|
2.44 µg/mL
Interval 1.97 to 3.02
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-19F
|
2.01 µg/mL
Interval 1.32 to 3.08
|
2.28 µg/mL
Interval 1.72 to 3.02
|
2.53 µg/mL
Interval 1.91 to 3.34
|
1.59 µg/mL
Interval 1.15 to 2.2
|
2.22 µg/mL
Interval 1.74 to 2.84
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-23F
|
0.73 µg/mL
Interval 0.49 to 1.09
|
0.85 µg/mL
Interval 0.63 to 1.14
|
0.51 µg/mL
Interval 0.39 to 0.67
|
0.53 µg/mL
Interval 0.38 to 0.73
|
0.52 µg/mL
Interval 0.37 to 0.72
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-6B
|
0.67 µg/mL
Interval 0.42 to 1.06
|
0.73 µg/mL
Interval 0.56 to 0.97
|
0.60 µg/mL
Interval 0.47 to 0.77
|
0.76 µg/mL
Interval 0.56 to 1.03
|
0.57 µg/mL
Interval 0.44 to 0.74
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-9V
|
1.15 µg/mL
Interval 0.77 to 1.71
|
1.30 µg/mL
Interval 1.04 to 1.63
|
1.05 µg/mL
Interval 0.86 to 1.28
|
0.85 µg/mL
Interval 0.68 to 1.06
|
0.80 µg/mL
Interval 0.64 to 1.0
|
SECONDARY outcome
Timeframe: At Month 3 and at Month 9Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.
Outcome measures
| Measure |
HIV+/+ Group
n=68 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=91 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=93 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=92 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=96 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-1 [Month 3]
|
139.7 Titers
Interval 85.2 to 229.0
|
147.6 Titers
Interval 102.9 to 211.7
|
127.2 Titers
Interval 86.2 to 187.8
|
268.7 Titers
Interval 196.7 to 366.9
|
160.6 Titers
Interval 117.8 to 218.8
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-1 [Month 9]
|
1061.5 Titers
Interval 680.5 to 1655.8
|
1377.8 Titers
Interval 984.9 to 1927.4
|
1014.8 Titers
Interval 768.4 to 1340.3
|
23.5 Titers
Interval 16.1 to 34.4
|
1003.6 Titers
Interval 763.2 to 1319.8
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-4 [Month 3]
|
671.6 Titers
Interval 430.7 to 1047.5
|
1518.1 Titers
Interval 1149.7 to 2004.4
|
1711.9 Titers
Interval 1367.7 to 2142.9
|
1890.6 Titers
Interval 1547.2 to 2310.2
|
774.8 Titers
Interval 596.7 to 1006.0
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-4 [Month 9]
|
2034.2 Titers
Interval 1593.5 to 2596.9
|
3259.0 Titers
Interval 2579.2 to 4117.9
|
2484.7 Titers
Interval 1919.0 to 3217.1
|
112.3 Titers
Interval 70.8 to 178.1
|
1717.6 Titers
Interval 1406.0 to 2098.2
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-5 [Month 3]
|
105.7 Titers
Interval 73.8 to 151.4
|
128.6 Titers
Interval 97.5 to 169.5
|
107.4 Titers
Interval 81.8 to 141.0
|
189.2 Titers
Interval 147.0 to 243.5
|
105.7 Titers
Interval 81.6 to 136.8
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-5 [Month 9]
|
540.4 Titers
Interval 366.4 to 796.9
|
531.1 Titers
Interval 397.3 to 710.0
|
630.2 Titers
Interval 447.5 to 887.7
|
30.5 Titers
Interval 21.8 to 42.5
|
472.7 Titers
Interval 343.5 to 650.5
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-6B [Month 3]
|
239.7 Titers
Interval 123.0 to 467.4
|
480.5 Titers
Interval 282.1 to 818.5
|
499.5 Titers
Interval 286.1 to 872.2
|
1213.7 Titers
Interval 808.2 to 1822.6
|
361.2 Titers
Interval 221.8 to 588.2
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-6B [Month 9]
|
853.0 Titers
Interval 467.8 to 1555.3
|
986.6 Titers
Interval 667.6 to 1457.9
|
1047.2 Titers
Interval 679.3 to 1614.4
|
261.5 Titers
Interval 161.0 to 424.7
|
945.9 Titers
Interval 640.0 to 1398.2
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-7F [Month 3]
|
4025.2 Titers
Interval 2609.7 to 6208.4
|
10158.3 Titers
Interval 7772.0 to 13277.2
|
5910.5 Titers
Interval 4696.9 to 7437.6
|
6834.5 Titers
Interval 5280.8 to 8845.4
|
2650.0 Titers
Interval 2002.0 to 3507.9
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-7F [Month 9]
|
10656.1 Titers
Interval 7729.9 to 14690.0
|
18816.6 Titers
Interval 14352.2 to 24669.7
|
12108.8 Titers
Interval 9922.2 to 14777.4
|
2741.1 Titers
Interval 2173.7 to 3456.5
|
6029.3 Titers
Interval 4760.9 to 7635.6
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-9V [Month 3]
|
1197.2 Titers
Interval 796.2 to 1800.1
|
1736.5 Titers
Interval 1224.1 to 2463.5
|
1672.2 Titers
Interval 1243.6 to 2248.4
|
2216.0 Titers
Interval 1760.9 to 2788.8
|
1068.2 Titers
Interval 759.2 to 1503.0
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-9V [Month 9]
|
2436.8 Titers
Interval 1736.5 to 3419.7
|
3215.4 Titers
Interval 2515.8 to 4109.6
|
4250.1 Titers
Interval 3493.4 to 5170.8
|
492.3 Titers
Interval 351.2 to 690.1
|
2572.5 Titers
Interval 1890.3 to 3500.8
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-14 [Month 3]
|
2656.2 Titers
Interval 1686.7 to 4183.0
|
3175.1 Titers
Interval 2472.8 to 4077.0
|
1902.7 Titers
Interval 1300.9 to 2782.9
|
2205.0 Titers
Interval 1648.8 to 2948.7
|
380.9 Titers
Interval 228.1 to 636.0
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-14 [Month 9]
|
2205.9 Titers
Interval 1570.2 to 3099.0
|
2374.3 Titers
Interval 1923.2 to 2931.2
|
2180.0 Titers
Interval 1781.9 to 2667.0
|
280.0 Titers
Interval 183.0 to 428.6
|
1152.9 Titers
Interval 910.6 to 1459.6
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-18C [Month 3]
|
438.7 Titers
Interval 284.1 to 677.3
|
575.9 Titers
Interval 442.9 to 748.8
|
1046.9 Titers
Interval 802.6 to 1365.5
|
1203.2 Titers
Interval 981.2 to 1475.4
|
1052.3 Titers
Interval 777.7 to 1423.8
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-18C [Month 9]
|
1039.3 Titers
Interval 770.2 to 1402.3
|
1036.5 Titers
Interval 800.1 to 1342.7
|
1344.4 Titers
Interval 1074.6 to 1681.9
|
64.5 Titers
Interval 44.1 to 94.3
|
1441.3 Titers
Interval 1111.7 to 1868.5
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-19F [Month 3]
|
228.6 Titers
Interval 132.5 to 394.4
|
590.3 Titers
Interval 418.9 to 831.6
|
511.9 Titers
Interval 394.1 to 664.9
|
649.3 Titers
Interval 481.1 to 876.2
|
275.9 Titers
Interval 193.4 to 393.5
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-19F [Month 9]
|
488.2 Titers
Interval 275.3 to 865.9
|
1357.5 Titers
Interval 976.2 to 1887.8
|
730.8 Titers
Interval 516.5 to 1034.1
|
46.8 Titers
Interval 31.6 to 69.5
|
630.3 Titers
Interval 422.9 to 939.5
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-23F [Month 3]
|
338.0 Titers
Interval 174.1 to 656.2
|
769.6 Titers
Interval 451.1 to 1312.9
|
864.1 Titers
Interval 511.2 to 1460.6
|
1107.0 Titers
Interval 683.0 to 1794.0
|
509.6 Titers
Interval 306.8 to 846.6
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-23F [Month 9]
|
1327.4 Titers
Interval 736.2 to 2393.5
|
2120.7 Titers
Interval 1359.4 to 3308.1
|
2144.8 Titers
Interval 1312.5 to 3504.8
|
83.6 Titers
Interval 47.2 to 148.0
|
1557.2 Titers
Interval 1012.2 to 2395.7
|
SECONDARY outcome
Timeframe: up to study end at Month 23 (24-27 months of age)Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.
Outcome measures
| Measure |
HIV+/+ Group
n=59 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=84 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=89 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=86 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=91 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-5
|
22.5 Titers
Interval 13.7 to 37.0
|
19.1 Titers
Interval 13.9 to 26.2
|
19.5 Titers
Interval 14.2 to 26.7
|
8.6 Titers
Interval 6.5 to 11.3
|
13.3 Titers
Interval 10.2 to 17.3
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-1
|
36.7 Titers
Interval 19.6 to 68.9
|
28.1 Titers
Interval 17.4 to 45.4
|
22.8 Titers
Interval 14.9 to 34.9
|
12.3 Titers
Interval 8.2 to 18.6
|
13.9 Titers
Interval 9.8 to 19.7
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-4
|
76.6 Titers
Interval 36.8 to 159.5
|
141.7 Titers
Interval 79.2 to 253.5
|
125.5 Titers
Interval 69.1 to 228.2
|
21.6 Titers
Interval 12.4 to 37.5
|
58.8 Titers
Interval 33.0 to 105.0
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-6B
|
100.0 Titers
Interval 48.8 to 204.7
|
75.5 Titers
Interval 44.2 to 128.8
|
116.6 Titers
Interval 63.7 to 213.3
|
87.2 Titers
Interval 48.2 to 157.7
|
55.9 Titers
Interval 32.0 to 97.7
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-7F
|
6367.5 Titers
Interval 4511.3 to 8987.6
|
7396.6 Titers
Interval 5736.2 to 9537.6
|
6365.0 Titers
Interval 5177.2 to 7825.4
|
5601.1 Titers
Interval 4334.9 to 7237.3
|
5859.9 Titers
Interval 4371.4 to 7855.2
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-9V
|
507.6 Titers
Interval 315.2 to 817.5
|
598.6 Titers
Interval 396.9 to 902.7
|
1060.7 Titers
Interval 761.2 to 1478.1
|
412.3 Titers
Interval 267.4 to 635.9
|
465.7 Titers
Interval 318.2 to 681.6
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-14
|
452.0 Titers
Interval 270.6 to 755.0
|
472.8 Titers
Interval 305.1 to 732.6
|
362.3 Titers
Interval 229.7 to 571.6
|
361.5 Titers
Interval 213.2 to 613.2
|
185.2 Titers
Interval 105.8 to 324.1
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-18C
|
21.1 Titers
Interval 13.0 to 34.4
|
26.7 Titers
Interval 17.1 to 41.6
|
48.7 Titers
Interval 30.4 to 78.1
|
9.8 Titers
Interval 6.6 to 14.5
|
41.6 Titers
Interval 27.3 to 63.3
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-19F
|
41.8 Titers
Interval 23.5 to 74.4
|
73.2 Titers
Interval 47.0 to 114.0
|
52.5 Titers
Interval 33.2 to 83.1
|
28.2 Titers
Interval 17.8 to 44.6
|
47.6 Titers
Interval 30.1 to 75.1
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Opsono-23F
|
97.6 Titers
Interval 38.2 to 249.6
|
154.8 Titers
Interval 71.7 to 334.2
|
69.7 Titers
Interval 31.7 to 153.1
|
92.7 Titers
Interval 40.7 to 211.2
|
103.5 Titers
Interval 47.0 to 227.7
|
SECONDARY outcome
Timeframe: At Month 3 and Month 9Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL.
Outcome measures
| Measure |
HIV+/+ Group
n=70 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=91 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=93 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=93 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=97 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Anti-6A [Month 3]
|
0.15 µg/mL
Interval 0.12 to 0.19
|
0.12 µg/mL
Interval 0.1 to 0.15
|
0.12 µg/mL
Interval 0.1 to 0.15
|
0.13 µg/mL
Interval 0.11 to 0.16
|
0.11 µg/mL
Interval 0.09 to 0.13
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Anti-6A [Month 9]
|
0.48 µg/mL
Interval 0.34 to 0.67
|
0.58 µg/mL
Interval 0.43 to 0.77
|
0.36 µg/mL
Interval 0.27 to 0.49
|
0.21 µg/mL
Interval 0.15 to 0.28
|
0.36 µg/mL
Interval 0.28 to 0.47
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Anti-19A [Month 9]
|
0.99 µg/mL
Interval 0.61 to 1.61
|
1.48 µg/mL
Interval 1.06 to 2.08
|
0.78 µg/mL
Interval 0.57 to 1.07
|
0.26 µg/mL
Interval 0.19 to 0.37
|
1.04 µg/mL
Interval 0.72 to 1.49
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Anti-19A [Month 3]
|
0.16 µg/mL
Interval 0.12 to 0.23
|
0.28 µg/mL
Interval 0.21 to 0.36
|
0.20 µg/mL
Interval 0.16 to 0.25
|
0.29 µg/mL
Interval 0.23 to 0.38
|
0.25 µg/mL
Interval 0.2 to 0.32
|
SECONDARY outcome
Timeframe: up to study end at Month 23 (24-27 months of age)Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. The cut-off of the assay is 0.05 µg/mL.
Outcome measures
| Measure |
HIV+/+ Group
n=63 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=86 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=92 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=91 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=97 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Anti-6A
|
0.23 µg/mL
Interval 0.14 to 0.38
|
0.25 µg/mL
Interval 0.17 to 0.35
|
0.20 µg/mL
Interval 0.15 to 0.27
|
0.25 µg/mL
Interval 0.18 to 0.36
|
0.19 µg/mL
Interval 0.14 to 0.26
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Anti-19A
|
0.45 µg/mL
Interval 0.26 to 0.76
|
0.47 µg/mL
Interval 0.31 to 0.72
|
0.53 µg/mL
Interval 0.35 to 0.8
|
0.41 µg/mL
Interval 0.28 to 0.6
|
0.58 µg/mL
Interval 0.41 to 0.83
|
SECONDARY outcome
Timeframe: At Month 3 and at Month 9Population: ATP cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.
Outcome measures
| Measure |
HIV+/+ Group
n=67 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=91 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=93 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=91 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=95 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Opsono -6A [Month 3]
|
7.7 Titers
Interval 5.2 to 11.5
|
11.5 Titers
Interval 7.4 to 17.9
|
12.1 Titers
Interval 7.8 to 18.9
|
13.8 Titers
Interval 9.1 to 20.9
|
8.1 Titers
Interval 5.8 to 11.3
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Opsono -6A [Month 9]
|
26.4 Titers
Interval 14.7 to 47.3
|
38.6 Titers
Interval 22.2 to 67.0
|
40.4 Titers
Interval 22.9 to 71.4
|
9.5 Titers
Interval 6.5 to 14.0
|
42.2 Titers
Interval 25.5 to 69.9
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Opsono -19A [Month 3]
|
9.5 Titers
Interval 6.4 to 14.0
|
15.2 Titers
Interval 10.4 to 22.2
|
10.6 Titers
Interval 7.7 to 14.7
|
14.2 Titers
Interval 9.7 to 20.8
|
7.8 Titers
Interval 5.9 to 10.2
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Opsono -19A [Month 9]
|
42.0 Titers
Interval 24.8 to 71.2
|
101.8 Titers
Interval 63.9 to 162.3
|
38.3 Titers
Interval 24.1 to 60.9
|
7.9 Titers
Interval 5.7 to 10.9
|
36.1 Titers
Interval 22.3 to 58.3
|
SECONDARY outcome
Timeframe: up to study end at Month 23 (24-27 months of age)Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.
Outcome measures
| Measure |
HIV+/+ Group
n=56 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=79 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=80 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=82 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=81 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Opsono-6A
|
14.2 Titers
Interval 7.5 to 27.2
|
15.7 Titers
Interval 9.4 to 26.2
|
20.5 Titers
Interval 12.2 to 34.3
|
15.3 Titers
Interval 8.5 to 27.5
|
19.0 Titers
Interval 11.4 to 31.9
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Opsono-19A
|
19.9 Titers
Interval 11.4 to 34.8
|
15.8 Titers
Interval 10.0 to 24.8
|
25.1 Titers
Interval 15.1 to 41.9
|
14.5 Titers
Interval 9.4 to 22.6
|
16.8 Titers
Interval 10.9 to 26.0
|
SECONDARY outcome
Timeframe: At Month 3 and at Month 9Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.
Outcome measures
| Measure |
HIV+/+ Group
n=70 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=91 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=93 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=94 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=97 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Protein D (PD) by ELISA
Anti-PD [Month 3]
|
4215.1 EL.U/mL
Interval 3622.3 to 4905.0
|
3397.6 EL.U/mL
Interval 2917.2 to 3957.1
|
3431.8 EL.U/mL
Interval 2955.1 to 3985.4
|
4253.1 EL.U/mL
Interval 3721.0 to 4861.4
|
2240.0 EL.U/mL
Interval 1871.0 to 2681.9
|
|
Concentrations of Antibodies Against Protein D (PD) by ELISA
Anti-PD [Month 9]
|
5443.1 EL.U/mL
Interval 4705.0 to 6297.0
|
5018.3 EL.U/mL
Interval 4335.7 to 5808.5
|
4576.5 EL.U/mL
Interval 3938.2 to 5318.3
|
930.4 EL.U/mL
Interval 770.0 to 1124.2
|
3141.0 EL.U/mL
Interval 2619.0 to 3767.0
|
SECONDARY outcome
Timeframe: up to study end at Month 23 (24-27 months of age)Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.
Outcome measures
| Measure |
HIV+/+ Group
n=63 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=86 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=92 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=91 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=97 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Protein D (PD) by ELISA.
|
748.3 EL.U/mL
Interval 581.8 to 962.3
|
615.3 EL.U/mL
Interval 495.8 to 763.4
|
503.2 EL.U/mL
Interval 421.0 to 601.5
|
421.3 EL.U/mL
Interval 334.2 to 531.1
|
323.0 EL.U/mL
Interval 255.6 to 408.1
|
SECONDARY outcome
Timeframe: 1 month following primary immunization (at Month 3)Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL) The cut-off of the assay is 0.1IU/mL.
Outcome measures
| Measure |
HIV+/+ Group
n=70 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=91 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=93 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=94 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=97 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
Anti-TT
|
5.03 IU/mL
Interval 4.16 to 6.07
|
4.77 IU/mL
Interval 4.03 to 5.63
|
4.50 IU/mL
Interval 3.89 to 5.21
|
5.03 IU/mL
Interval 4.33 to 5.85
|
4.24 IU/mL
Interval 3.5 to 5.14
|
|
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
Anti-DT
|
2.42 IU/mL
Interval 1.92 to 3.06
|
3.69 IU/mL
Interval 3.19 to 4.26
|
3.42 IU/mL
Interval 2.96 to 3.96
|
4.20 IU/mL
Interval 3.76 to 4.68
|
3.00 IU/mL
Interval 2.58 to 3.49
|
SECONDARY outcome
Timeframe: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)Population: The According-To-Protocol cohort for immunogenicity at 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.
Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL). The cut-off of the assay is 0.1IU/mL.
Outcome measures
| Measure |
HIV+/+ Group
n=59 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=81 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=91 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=87 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=92 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
Anti-DT
|
9.57 IU/mL
Interval 7.91 to 11.59
|
11.70 IU/mL
Interval 10.28 to 13.32
|
10.45 IU/mL
Interval 9.18 to 11.89
|
12.67 IU/mL
Interval 10.82 to 14.83
|
11.96 IU/mL
Interval 10.48 to 13.64
|
|
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
Anti-TT
|
14.44 IU/mL
Interval 12.2 to 17.09
|
14.60 IU/mL
Interval 12.58 to 16.95
|
16.19 IU/mL
Interval 14.18 to 18.48
|
17.69 IU/mL
Interval 15.57 to 20.11
|
19.77 IU/mL
Interval 17.74 to 22.04
|
SECONDARY outcome
Timeframe: 1 month following primary immunization (at Month 3)Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL.
Outcome measures
| Measure |
HIV+/+ Group
n=70 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=91 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=93 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=92 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=97 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA.
|
90.86 EL.U/mL
Interval 74.89 to 110.23
|
132.27 EL.U/mL
Interval 118.6 to 147.51
|
143.08 EL.U/mL
Interval 129.44 to 158.17
|
152.23 EL.U/mL
Interval 137.86 to 168.1
|
146.60 EL.U/mL
Interval 129.19 to 166.34
|
SECONDARY outcome
Timeframe: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)Population: The ATP cohort for immunogenicityat 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.
Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL.
Outcome measures
| Measure |
HIV+/+ Group
n=59 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=81 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=90 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=87 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=92 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA .
|
161.01 EL.U/mL
Interval 131.88 to 196.58
|
227.01 EL.U/mL
Interval 202.86 to 254.03
|
241.77 EL.U/mL
Interval 218.18 to 267.9
|
259.45 EL.U/mL
Interval 234.7 to 286.81
|
267.80 EL.U/mL
Interval 243.49 to 294.54
|
SECONDARY outcome
Timeframe: 1 month following primary immunization (at Month 3)Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL.
Outcome measures
| Measure |
HIV+/+ Group
n=70 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=91 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=93 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=93 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=97 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
|
16.71 µg/mL
Interval 11.63 to 24.01
|
20.55 µg/mL
Interval 15.78 to 26.78
|
20.36 µg/mL
Interval 15.56 to 26.64
|
24.22 µg/mL
Interval 18.45 to 31.8
|
21.78 µg/mL
Interval 16.47 to 28.79
|
SECONDARY outcome
Timeframe: 1 month after the booster vaccination (at Month 15)Population: The ATP cohort for immunogenicity at 15 -18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.
Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL.
Outcome measures
| Measure |
HIV+/+ Group
n=59 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=80 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=91 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=87 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=92 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
|
50.11 µg/mL
Interval 33.29 to 75.43
|
71.23 µg/mL
Interval 55.03 to 92.19
|
83.46 µg/mL
Interval 64.51 to 107.98
|
93.18 µg/mL
Interval 69.67 to 124.64
|
129.99 µg/mL
Interval 103.73 to 162.89
|
SECONDARY outcome
Timeframe: 1 month following primary immunization (at Month 3)Population: According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay is 10 mIU/mL. As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis
Outcome measures
| Measure |
HIV+/+ Group
n=63 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=85 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=88 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=87 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=90 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA
|
288.45 mIU/mL
Interval 167.12 to 497.86
|
478.53 mIU/mL
Interval 333.22 to 687.22
|
865.5 mIU/mL
Interval 654.8 to 1144.1
|
904.7 mIU/mL
Interval 646.0 to 1267.0
|
563.5 mIU/mL
Interval 373.8 to 849.4
|
SECONDARY outcome
Timeframe: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)Population: The ATP cohort for immunogenicity at 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.
Concentrations of antibodies were presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay was 10 mIU/mL. As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis
Outcome measures
| Measure |
HIV+/+ Group
n=58 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=78 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=90 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=81 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=89 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA.
|
1871.0 mIU/mL
Interval 892.9 to 3920.7
|
2507.4 mIU/mL
Interval 1500.7 to 4189.4
|
3674.4 mIU/mL
Interval 2446.9 to 5517.9
|
4287.6 mIU/mL
Interval 2785.9 to 6598.8
|
3583.4 mIU/mL
Interval 2194.8 to 5850.6
|
SECONDARY outcome
Timeframe: 1 month after the administration of the second vaccine dose (at Month 3)Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Concentrations of antibodies are presented as GMCs expressed as units per millilitre (U/mL). The cut-off of the assay is 20 U/mL. Data were collected for subjects who received 1, 2 doses or no Rotarix dose during the study.
Outcome measures
| Measure |
HIV+/+ Group
n=58 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=59 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=66 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=66 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=67 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status.
Anti-rotavirus IgA [2 doses]
|
52.6 U/mL
Interval 33.8 to 81.8
|
104.1 U/mL
Interval 66.3 to 163.5
|
146.4 U/mL
Interval 94.2 to 227.4
|
92.0 U/mL
Interval 60.0 to 141.0
|
74.3 U/mL
Interval 47.5 to 116.3
|
|
Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status.
Anti-rotavirus IgA [0 dose]
|
54.8 U/mL
Interval 13.1 to 229.2
|
54.0 U/mL
Interval 21.3 to 136.8
|
63.1 U/mL
Interval 34.8 to 114.5
|
47.5 U/mL
Interval 26.5 to 85.3
|
41.7 U/mL
Interval 22.3 to 78.1
|
|
Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status.
Anti-rotavirus IgA [1 dose]
|
NA U/mL
No subject in this group received 1 dose of Rotarix.
|
NA U/mL
No subject in this group received 1 dose of Rotarix.
|
25.0 U/mL
Not calculable because of too few subjects
|
NA U/mL
Values were below the assay cut-off value of 20 U/mL
|
NA U/mL
No subject in this group received 1 dose of Rotarix.
|
SECONDARY outcome
Timeframe: 1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL).The cut-off of the assay is 150 mIU/mL.
Outcome measures
| Measure |
HIV+/+ Group
n=63 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=85 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=91 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=87 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=93 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Measles
Anti-Measles [Month 9]
|
2013.36 mIU/mL
Interval 1566.36 to 2587.94
|
1917.14 mIU/mL
Interval 1468.59 to 2502.68
|
1973.84 mIU/mL
Interval 1512.9 to 2575.22
|
1509.36 mIU/mL
Interval 1157.32 to 1968.5
|
1719.76 mIU/mL
Interval 1360.39 to 2174.08
|
|
Concentrations of Antibodies Against Measles
Anti-Measles [Month 15]
|
3358.15 mIU/mL
Interval 2578.34 to 4373.83
|
4189.83 mIU/mL
Interval 3451.63 to 5085.91
|
3713.51 mIU/mL
Interval 3050.3 to 4520.92
|
3311.30 mIU/mL
Interval 2698.56 to 4063.17
|
3204.79 mIU/mL
Interval 2659.0 to 3862.61
|
SECONDARY outcome
Timeframe: up to study end at Month 23 (24-27 months of age)Population: The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented
Salivary antibodies against selected common bacterial protein antigens. Salivary samples (1.0 mL) were collected by using an Oracol™ device consisting of a sponge (2 cm3) placed on a stick that was used to brush the teeth and gums to absorb the saliva. Salivary samples were sent to RMPRU (or GSK Biologicals' designated validated laboratory) where the sponge was centrifuged to extract the saliva and that was immediately stored at -70°C. The cut-off of the assay was 2.3 U/mL for anti-LytC IgA and 2.2 U/mL for anti PhtD IgA.
Outcome measures
| Measure |
HIV+/+ Group
n=77 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=95 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=98 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=94 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=98 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-LytC [Month0]
|
7.71 U/mL
Interval 5.44 to 10.95
|
5.49 U/mL
Interval 3.81 to 7.91
|
6.22 U/mL
Interval 4.35 to 8.9
|
5.98 U/mL
Interval 4.24 to 8.43
|
6.67 U/mL
Interval 4.89 to 9.08
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-LytC [Month3]
|
18.30 U/mL
Interval 13.29 to 25.22
|
13.48 U/mL
Interval 10.46 to 17.37
|
13.29 U/mL
Interval 10.5 to 16.82
|
13.81 U/mL
Interval 10.56 to 18.06
|
14.43 U/mL
Interval 11.32 to 18.39
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-LytC [Month8]
|
27.23 U/mL
Interval 18.88 to 39.29
|
15.99 U/mL
Interval 12.29 to 20.79
|
24.51 U/mL
Interval 18.63 to 32.24
|
22.64 U/mL
Interval 16.56 to 30.96
|
21.85 U/mL
Interval 16.32 to 29.25
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-LytC [Month9]
|
30.96 U/mL
Interval 20.88 to 45.88
|
15.54 U/mL
Interval 11.72 to 20.61
|
24.60 U/mL
Interval 17.89 to 33.83
|
21.06 U/mL
Interval 15.15 to 29.27
|
25.00 U/mL
Interval 18.66 to 33.5
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-LytC [Month11]
|
37.01 U/mL
Interval 24.64 to 55.59
|
18.79 U/mL
Interval 13.94 to 25.32
|
43.03 U/mL
Interval 30.64 to 60.44
|
35.65 U/mL
Interval 26.47 to 48.02
|
38.07 U/mL
Interval 28.23 to 51.34
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-LytC [Month14]
|
39.45 U/mL
Interval 28.22 to 55.15
|
24.69 U/mL
Interval 18.48 to 32.97
|
39.59 U/mL
Interval 28.87 to 54.29
|
38.87 U/mL
Interval 29.26 to 51.63
|
34.75 U/mL
Interval 26.4 to 45.74
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-LytC [Month15]
|
58.11 U/mL
Interval 38.95 to 86.69
|
28.09 U/mL
Interval 21.12 to 37.36
|
42.43 U/mL
Interval 31.21 to 57.68
|
50.45 U/mL
Interval 38.7 to 65.77
|
42.98 U/mL
Interval 32.28 to 57.22
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-LytC [Month23]
|
89.32 U/mL
Interval 63.92 to 124.81
|
43.61 U/mL
Interval 32.16 to 59.14
|
68.34 U/mL
Interval 51.15 to 91.32
|
61.40 U/mL
Interval 48.68 to 77.45
|
59.75 U/mL
Interval 45.69 to 78.12
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-PhtD [Month0]
|
4.58 U/mL
Interval 3.36 to 6.25
|
3.83 U/mL
Interval 2.83 to 5.18
|
7.85 U/mL
Interval 5.18 to 11.9
|
6.30 U/mL
Interval 4.39 to 9.04
|
5.49 U/mL
Interval 3.73 to 8.08
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-PhtD [Month3]
|
5.49 U/mL
Interval 3.97 to 7.59
|
4.92 U/mL
Interval 3.75 to 6.45
|
5.14 U/mL
Interval 4.07 to 6.49
|
5.06 U/mL
Interval 3.96 to 6.47
|
5.10 U/mL
Interval 4.02 to 6.47
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-PhtD [Month8]
|
7.77 U/mL
Interval 5.46 to 11.06
|
5.86 U/mL
Interval 4.51 to 7.62
|
9.49 U/mL
Interval 7.1 to 12.69
|
10.01 U/mL
Interval 7.1 to 14.12
|
8.35 U/mL
Interval 6.22 to 11.21
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-PhtD [Month9]
|
9.16 U/mL
Interval 6.37 to 13.17
|
7.32 U/mL
Interval 5.5 to 9.73
|
16.47 U/mL
Interval 11.34 to 23.94
|
14.01 U/mL
Interval 9.77 to 20.11
|
11.71 U/mL
Interval 8.45 to 16.23
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-PhtD [Month11]
|
9.49 U/mL
Interval 6.86 to 13.14
|
7.92 U/mL
Interval 5.76 to 10.9
|
16.93 U/mL
Interval 11.58 to 24.75
|
15.41 U/mL
Interval 10.83 to 21.94
|
15.70 U/mL
Interval 11.36 to 21.7
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-PhtD [Month14]
|
14.06 U/mL
Interval 9.92 to 19.92
|
10.74 U/mL
Interval 8.01 to 14.4
|
19.39 U/mL
Interval 13.98 to 26.87
|
22.04 U/mL
Interval 16.09 to 30.2
|
14.54 U/mL
Interval 10.62 to 19.92
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-PhtD [Month15]
|
15.04 U/mL
Interval 10.08 to 22.46
|
11.35 U/mL
Interval 8.27 to 15.59
|
18.06 U/mL
Interval 13.04 to 25.02
|
24.03 U/mL
Interval 17.55 to 32.92
|
17.07 U/mL
Interval 12.08 to 24.12
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Anti-PhtD [Month23]
|
41.41 U/mL
Interval 27.82 to 61.62
|
29.17 U/mL
Interval 20.84 to 40.83
|
39.84 U/mL
Interval 28.47 to 55.75
|
35.69 U/mL
Interval 26.26 to 48.5
|
35.92 U/mL
Interval 26.6 to 48.52
|
SECONDARY outcome
Timeframe: up to study end at Month 23 (24-27 months of age)Population: The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented
Positive cultures of H. influenza\* (HI) and S. pneumonia(SP) and other bacterial pathogens such as Moraxella catarrhalis(MC), Group A streptococci and Staphylococcus aureus (SA), identified in the nasopharynx at each swab time point: Month (Mth) 0 (Pre-vaccination time point at 6-12 weeks of age), Mth 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). \*Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay
Outcome measures
| Measure |
HIV+/+ Group
n=83 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=101 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=100 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=100 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=100 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SP - Mth 0
|
23 Swabs
|
24 Swabs
|
25 Swabs
|
30 Swabs
|
17 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SP - Mth 9
|
50 Swabs
|
64 Swabs
|
62 Swabs
|
66 Swabs
|
70 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SA - Mth 0
|
37 Swabs
|
48 Swabs
|
56 Swabs
|
57 Swabs
|
55 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any MC - Mth 23
|
59 Swabs
|
73 Swabs
|
78 Swabs
|
71 Swabs
|
79 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SA - Mth 3
|
41 Swabs
|
37 Swabs
|
37 Swabs
|
40 Swabs
|
32 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SA - Mth 11
|
9 Swabs
|
18 Swabs
|
13 Swabs
|
13 Swabs
|
19 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SP - Mth 3
|
47 Swabs
|
62 Swabs
|
58 Swabs
|
55 Swabs
|
64 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SP - Mth 8
|
55 Swabs
|
61 Swabs
|
65 Swabs
|
67 Swabs
|
67 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SP - Mth 11
|
52 Swabs
|
61 Swabs
|
67 Swabs
|
62 Swabs
|
70 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SP - Mth 14
|
52 Swabs
|
64 Swabs
|
69 Swabs
|
70 Swabs
|
70 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SP - Mth 15
|
59 Swabs
|
68 Swabs
|
62 Swabs
|
70 Swabs
|
68 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SP - Mth 23
|
58 Swabs
|
59 Swabs
|
63 Swabs
|
60 Swabs
|
66 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any HI - Mth 0
|
14 Swabs
|
12 Swabs
|
17 Swabs
|
12 Swabs
|
12 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SA - Mth 8
|
16 Swabs
|
18 Swabs
|
13 Swabs
|
19 Swabs
|
24 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any HI - Mth 3
|
30 Swabs
|
34 Swabs
|
36 Swabs
|
33 Swabs
|
37 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any HI - Mth 8
|
21 Swabs
|
41 Swabs
|
34 Swabs
|
30 Swabs
|
38 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any HI - Mth 9
|
28 Swabs
|
47 Swabs
|
34 Swabs
|
29 Swabs
|
32 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any HI - Mth 11
|
33 Swabs
|
44 Swabs
|
36 Swabs
|
34 Swabs
|
40 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any HI - Mth 14
|
29 Swabs
|
39 Swabs
|
38 Swabs
|
31 Swabs
|
27 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any HI - Mth 15
|
35 Swabs
|
54 Swabs
|
54 Swabs
|
51 Swabs
|
55 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any HI - Mth 23
|
39 Swabs
|
45 Swabs
|
58 Swabs
|
53 Swabs
|
62 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any MC - Mth 0
|
35 Swabs
|
39 Swabs
|
42 Swabs
|
42 Swabs
|
44 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any MC - Mth 3
|
63 Swabs
|
88 Swabs
|
88 Swabs
|
87 Swabs
|
90 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any MC - Mth 8
|
56 Swabs
|
83 Swabs
|
84 Swabs
|
79 Swabs
|
82 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any MC - Mth 9
|
62 Swabs
|
79 Swabs
|
75 Swabs
|
81 Swabs
|
72 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any MC - Mth 11
|
69 Swabs
|
80 Swabs
|
73 Swabs
|
73 Swabs
|
83 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any MC - Mth 14
|
65 Swabs
|
81 Swabs
|
84 Swabs
|
90 Swabs
|
84 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any MC - Mth 15
|
60 Swabs
|
82 Swabs
|
83 Swabs
|
87 Swabs
|
86 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SA - Mth 9
|
19 Swabs
|
26 Swabs
|
18 Swabs
|
16 Swabs
|
17 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SA - Mth 14
|
11 Swabs
|
15 Swabs
|
9 Swabs
|
13 Swabs
|
13 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SA - Mth 15
|
12 Swabs
|
11 Swabs
|
20 Swabs
|
13 Swabs
|
18 Swabs
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Any SA - Mth 23
|
8 Swabs
|
16 Swabs
|
10 Swabs
|
13 Swabs
|
18 Swabs
|
SECONDARY outcome
Timeframe: up to study end at Month 23 (24-27 months of age)Population: The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented
Acquisition of new H. influenza\* (HI) and S. pneumonia(SP) strains, identified in the nasopharynx at each swab time point: Month (Mth) 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). \*Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by PCR assay
Outcome measures
| Measure |
HIV+/+ Group
n=81 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=98 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=98 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=95 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=98 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any SP - Mth 3
|
35 Participants
|
47 Participants
|
46 Participants
|
41 Participants
|
56 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any SP - Mth 8
|
59 Participants
|
68 Participants
|
70 Participants
|
67 Participants
|
76 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any SP - Mth 9
|
64 Participants
|
76 Participants
|
77 Participants
|
78 Participants
|
82 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any SP - Mth 11
|
69 Participants
|
79 Participants
|
84 Participants
|
84 Participants
|
90 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any SP - Mth 14
|
68 Participants
|
82 Participants
|
90 Participants
|
90 Participants
|
93 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any SP - Mth 15
|
72 Participants
|
86 Participants
|
90 Participants
|
92 Participants
|
94 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any SP - Mth 23
|
72 Participants
|
87 Participants
|
95 Participants
|
90 Participants
|
96 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any HI - Mth 3
|
26 Participants
|
25 Participants
|
27 Participants
|
29 Participants
|
30 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any HI - Mth 8
|
34 Participants
|
49 Participants
|
48 Participants
|
42 Participants
|
45 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any HI - Mth 9
|
45 Participants
|
63 Participants
|
52 Participants
|
52 Participants
|
57 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any HI - Mth 11
|
55 Participants
|
67 Participants
|
60 Participants
|
57 Participants
|
65 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any HI - Mth 14
|
56 Participants
|
60 Participants
|
58 Participants
|
54 Participants
|
59 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any HI - Mth 15
|
59 Participants
|
67 Participants
|
64 Participants
|
58 Participants
|
65 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Any HI - Mth 23
|
60 Participants
|
70 Participants
|
71 Participants
|
59 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-primary vaccination period across dosesPopulation: The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.
Outcome measures
| Measure |
HIV+/+ Group
n=83 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=101 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=98 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=98 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=98 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Any pain
|
73 Participants
|
93 Participants
|
92 Participants
|
95 Participants
|
97 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Grade 3 pain
|
18 Participants
|
18 Participants
|
28 Participants
|
42 Participants
|
34 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Any redness
|
62 Participants
|
80 Participants
|
83 Participants
|
83 Participants
|
84 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Redness > 30 mm
|
14 Participants
|
10 Participants
|
17 Participants
|
20 Participants
|
14 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Any swelling
|
67 Participants
|
83 Participants
|
84 Participants
|
91 Participants
|
84 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Swelling > 30 mm
|
23 Participants
|
32 Participants
|
41 Participants
|
44 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-primary vaccination period across dosesPopulation: The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
General AEs = diarrhoea, drowsiness, irritability, loss of appetite, vomiting and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. diarrhoea: ≥ 6 looser than normal stools/day. vomiting: ≥ 3 episodes of vomiting/day. Fever = \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
HIV+/+ Group
n=83 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=101 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=98 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=98 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=98 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Any diarrhoea
|
8 Participants
|
5 Participants
|
12 Participants
|
10 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Grade 3 drowsiness
|
1 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Any loss of appetite
|
36 Participants
|
53 Participants
|
56 Participants
|
57 Participants
|
62 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Grade 3 vomiting
|
3 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Related vomiting
|
16 Participants
|
16 Participants
|
14 Participants
|
13 Participants
|
17 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Grade 3 diarrhoea
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Related diarrhoea
|
8 Participants
|
5 Participants
|
11 Participants
|
9 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Any drowsiness
|
49 Participants
|
62 Participants
|
70 Participants
|
70 Participants
|
68 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Related drowsiness
|
47 Participants
|
58 Participants
|
67 Participants
|
66 Participants
|
63 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Fever (axillary) >= 37.5°C
|
38 Participants
|
36 Participants
|
41 Participants
|
28 Participants
|
28 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Fever (axillary) > 39.5°C
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Related fever
|
33 Participants
|
30 Participants
|
38 Participants
|
27 Participants
|
25 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Any irritability
|
63 Participants
|
84 Participants
|
89 Participants
|
89 Participants
|
91 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Grade 3 irritability
|
6 Participants
|
10 Participants
|
19 Participants
|
13 Participants
|
15 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Related irritability
|
62 Participants
|
80 Participants
|
86 Participants
|
83 Participants
|
85 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Grade 3 loss of appetite
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Related loss of appetite
|
35 Participants
|
47 Participants
|
53 Participants
|
53 Participants
|
58 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Any vomiting
|
17 Participants
|
19 Participants
|
15 Participants
|
18 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccinePopulation: The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.
Outcome measures
| Measure |
HIV+/+ Group
n=74 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=95 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=96 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=96 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Swelling > 30 mm
|
5 Participants
|
4 Participants
|
8 Participants
|
—
|
10 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Any pain
|
40 Participants
|
58 Participants
|
62 Participants
|
—
|
60 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Grade 3 pain
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
6 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Any redness
|
25 Participants
|
31 Participants
|
39 Participants
|
—
|
45 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Redness > 30 mm
|
5 Participants
|
1 Participants
|
3 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Any swelling
|
28 Participants
|
39 Participants
|
38 Participants
|
—
|
53 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccinePopulation: The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
HIV+/+ Group
n=74 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=95 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=96 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=96 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Any drowsiness
|
17 Participants
|
28 Participants
|
34 Participants
|
—
|
33 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Grade 3 drowsiness
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Related drowsiness
|
16 Participants
|
27 Participants
|
31 Participants
|
—
|
32 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Fever >= 37.5°C
|
9 Participants
|
11 Participants
|
7 Participants
|
—
|
11 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Fever > 39.5°C
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Related fever
|
8 Participants
|
10 Participants
|
7 Participants
|
—
|
10 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Any irritability
|
25 Participants
|
35 Participants
|
31 Participants
|
—
|
43 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Grade 3 irritability
|
4 Participants
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Related irritability
|
24 Participants
|
35 Participants
|
31 Participants
|
—
|
42 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Any loss of appetite
|
17 Participants
|
23 Participants
|
29 Participants
|
—
|
37 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Grade 3 loss of appetite
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Related loss of appetite
|
16 Participants
|
23 Participants
|
29 Participants
|
—
|
33 Participants
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) post-primary vaccination periodPopulation: The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Outcome measures
| Measure |
HIV+/+ Group
n=83 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=101 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=100 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=100 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=100 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited AEs.
|
73 Participants
|
92 Participants
|
93 Participants
|
90 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) post Synflorix booster vaccination periodPopulation: The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Outcome measures
| Measure |
HIV+/+ Group
n=76 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=96 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=98 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=98 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited AEs.
|
35 Participants
|
47 Participants
|
50 Participants
|
—
|
44 Participants
|
SECONDARY outcome
Timeframe: From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)Population: The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Outcome measures
| Measure |
HIV+/+ Group
n=83 Participants
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=101 Participants
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=100 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=100 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=100 Participants
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs).
|
31 Participants
|
25 Participants
|
20 Participants
|
15 Participants
|
20 Participants
|
Adverse Events
HIV+/+ Group
Serious events: 31 serious events
Other events: 83 other events
Deaths: 0 deaths
HIV+/- Group
Serious events: 25 serious events
Other events: 100 other events
Deaths: 0 deaths
HIV- (3+1) Group
Serious events: 20 serious events
Other events: 98 other events
Deaths: 0 deaths
HIV- (3+0) Group
Serious events: 15 serious events
Other events: 98 other events
Deaths: 0 deaths
HIV- (2+1) Group
Serious events: 20 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV+/+ Group
n=83 participants at risk
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=101 participants at risk
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=100 participants at risk
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=100 participants at risk
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=100 participants at risk
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Congenital, familial and genetic disorders
Cerebral palsy
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
General disorders
Death
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
General disorders
Sudden death
|
2.4%
2/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
General disorders
Sudden infant death syndrome
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Hepatobiliary disorders
Hepatitis neonatal
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Abscess limb
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
AIDS dementia complex
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Arthritis bacterial
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Bronchiolitis
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
4.0%
4/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Bronchitis
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Bronchopneumonia
|
15.7%
13/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
5.0%
5/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
6.0%
6/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
8.0%
8/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Cytomegalovirus infection
|
2.4%
2/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Gastroenteritis
|
9.6%
8/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
7.9%
8/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
5.0%
5/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
4.0%
4/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
4.0%
4/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
HIV infection
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Measles
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
2.0%
2/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Meningitis meningococcal
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Meningitis tuberculous
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Oral candidiasis
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Otitis media
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Pneumococcal sepsis
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
4.8%
4/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Pneumonia
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Pneumonia staphylococcal
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Pulmonary tuberculosis
|
13.3%
11/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Pyelonephritis
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Subacute endocarditis
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Tonsillitis
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
2.0%
2/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Tuberculosis
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Injury, poisoning and procedural complications
Herbal toxicity
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Injury, poisoning and procedural complications
Near drowning
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
2.0%
2/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Metabolism and nutrition disorders
Kwashiorkor
|
2.4%
2/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Metabolism and nutrition disorders
Marasmus
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Nervous system disorders
Convulsion
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
2.0%
2/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Nervous system disorders
Febrile convulsion
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
2.0%
2/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Renal and urinary disorders
Renal impairment
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
2.0%
2/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
Other adverse events
| Measure |
HIV+/+ Group
n=83 participants at risk
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV+/- Group
n=101 participants at risk
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+1) Group
n=100 participants at risk
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (3+0) Group
n=100 participants at risk
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
HIV- (2+1) Group
n=100 participants at risk
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 \& 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 \& 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 \& 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age \& 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
|
|---|---|---|---|---|---|
|
General disorders
Irritability
|
33.8%
25/74 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
36.8%
35/95 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
90.8%
89/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
90.8%
89/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
92.9%
91/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
General disorders
Loss of appetite
|
23.0%
17/74 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
24.2%
23/95 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
30.2%
29/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
—
0/0 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
38.5%
37/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
General disorders
Pain
|
54.1%
40/74 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
61.1%
58/95 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
64.6%
62/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
—
0/0 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
62.5%
60/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
General disorders
Redness
|
33.8%
25/74 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
32.6%
31/95 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
40.6%
39/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
—
0/0 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
46.9%
45/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
5/76 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
10.4%
10/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
10.2%
10/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
—
0/0 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
8.2%
8/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/76 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
8.3%
8/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
7.1%
7/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
—
0/0 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
5.1%
5/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
General disorders
Diarrhoea
|
9.6%
8/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
5.0%
5/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
12.2%
12/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
10.2%
10/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
5.1%
5/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
General disorders
Drowsiness
|
23.0%
17/74 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
29.5%
28/95 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
35.4%
34/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
—
0/0 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
34.4%
33/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
General disorders
Fever
|
12.2%
9/74 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
11.6%
11/95 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
7.3%
7/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
—
0/0 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
11.5%
11/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
General disorders
Swelling
|
37.8%
28/74 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
41.1%
39/95 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
39.6%
38/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
—
0/0 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
55.2%
53/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
General disorders
Vomiting
|
20.5%
17/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
18.8%
19/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
15.3%
15/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
18.4%
18/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
23.5%
23/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
2/76 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
5.2%
5/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
6.1%
6/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
—
0/0 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
5.1%
5/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.2%
6/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
8.9%
9/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
1.0%
1/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.4%
17/76 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
24.0%
23/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
24.5%
24/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
—
0/0 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
13.3%
13/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Obstruction
|
9.2%
7/76 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
4.2%
4/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
6.1%
6/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
—
0/0 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
6.1%
6/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.6%
3/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
8.9%
9/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
10.0%
10/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
9.0%
9/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
10.0%
10/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.8%
9/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
11.9%
12/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
11.0%
11/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
12.0%
12/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
14.0%
14/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
4/76 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
4.2%
4/96 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.1%
3/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
—
0/0 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
5.1%
5/98 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
General disorders
Pyrexia
|
6.0%
5/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
7.9%
8/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
5.0%
5/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
9.0%
9/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
9.0%
9/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Bronchiolitis
|
1.2%
1/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
5.9%
6/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
8.0%
8/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
2.0%
2/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Bronchopneumonia
|
6.0%
5/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.00%
0/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
2.0%
2/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Infections and infestations
Oral candidiasis
|
10.8%
9/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
4.0%
4/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
6.0%
6/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
8.9%
9/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
11.0%
11/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
6.0%
6/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
9.0%
9/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
14.5%
12/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
7.9%
8/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
11.0%
11/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
8.0%
8/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
4.0%
4/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Eye disorders
Eye discharge
|
4.8%
4/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
5.9%
6/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
6.0%
6/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
4.0%
4/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
4/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
0.99%
1/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
4.0%
4/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
9.0%
9/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/83 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/101 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
3.0%
3/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
5.0%
5/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
6.0%
6/100 • SAEs: from Month 0 up to Month 23. Unsolicited AEs: within the 31-day post-primary and post Synflorix booster vaccination period. Solicited AEs: During the 4-day period following the primary and the Synflorix booster vaccination.
|
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