Trial Outcomes & Findings for Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants (NCT NCT01231503)
NCT ID: NCT01231503
Last Updated: 2018-08-15
Results Overview
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
480 participants
Primary outcome timeframe
From study start at Month 0 up to Month 10.
Results posted on
2018-08-15
Participant Flow
480 subjects were enrolled into the study. Out of these 480 subjects, 479 were vaccinated and 1 was allocated a subject number but was not vaccinated.
480 subjects were enrolled into the study. Out of these 480 subjects, 479 were vaccinated and 1 was allocated a subject number but was not vaccinated.
Participant milestones
| Measure |
RTS,S Neo-10-14 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
59
|
60
|
60
|
60
|
60
|
60
|
60
|
|
Overall Study
COMPLETED
|
46
|
46
|
48
|
52
|
50
|
44
|
53
|
52
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
12
|
8
|
10
|
16
|
7
|
8
|
Reasons for withdrawal
| Measure |
RTS,S Neo-10-14 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse event, serious fatal
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
3
|
1
|
3
|
5
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
8
|
10
|
8
|
5
|
7
|
9
|
6
|
6
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants
Baseline characteristics by cohort
| Measure |
RTS,S Neo-10-14 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=59 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=60 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of TritanrixHepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=60 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Total
n=479 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
0.4 Days
STANDARD_DEVIATION 1.1 • n=5 Participants
|
0.4 Days
STANDARD_DEVIATION 1.2 • n=7 Participants
|
0.2 Days
STANDARD_DEVIATION 1.0 • n=5 Participants
|
0.2 Days
STANDARD_DEVIATION 0.8 • n=4 Participants
|
0.5 Days
STANDARD_DEVIATION 1.4 • n=21 Participants
|
0.2 Days
STANDARD_DEVIATION 0.8 • n=8 Participants
|
0.2 Days
STANDARD_DEVIATION 0.9 • n=8 Participants
|
0.4 Days
STANDARD_DEVIATION 1.2 • n=24 Participants
|
0.3 Days
STANDARD_DEVIATION 1.03 • n=42 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
237 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
32 Participants
n=24 Participants
|
242 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From study start at Month 0 up to Month 10.Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment.
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=59 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=60 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=60 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Serious Adverse Events (SAEs)
|
5 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
10 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M5 for RTS,S Neo-10-14, RTS,S 6-10-14 and Engerix-B Neo groupsPopulation: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=47 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=45 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=48 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
|
128.2 EL.U/mL
Interval 92.2 to 178.2
|
218.3 EL.U/mL
Interval 160.1 to 297.6
|
0 EL.U/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M7 for RTS,S Neo-10-26, RTS,S 6-10-26, Engerix-B Neo/RTS,S 6-10-26, and RTS,S 10-14-26 groupsPopulation: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=43 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=46 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=43 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=41 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
|
136.6 EL.U/mL
Interval 93.0 to 200.7
|
156.5 EL.U/mL
Interval 100.4 to 244.0
|
170.6 EL.U/mL
Interval 114.6 to 254.1
|
392.6 EL.U/mL
Interval 323.3 to 476.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M10 for RTS,S 14-26-9M GroupPopulation: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=47 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
|
269.9 EL.U/mL
Interval 183.3 to 397.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo GroupPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Please note that, for this outcome measure, analysis was performed only on subjects with at least one administered dose of RTS,S/AS01E and/or DTPwHepB/Hib for the Engerix-B Neo Group.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=59 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=57 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=52 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=52 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Unsolicited Adverse Events (AEs)
|
36 Participants
|
35 Participants
|
28 Participants
|
29 Participants
|
35 Participants
|
36 Participants
|
47 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: From study start at Month 0 up to Month 18 (corresponding data lock point =23 March 2015)Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment.
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=59 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=60 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=60 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Serious Adverse Events (SAEs)
|
7 Participants
|
5 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
12 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
This outcome measure concerns biochemical abnormalities, for the alanine aminotransferase (ALT) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal ALT level was defined as ALT\< 60 International units per milliliter (IU/mL). Grade 1 ALT level was defined as 1.1 to 2.5 times the upper limit of normal (ULN). Grade 2 ALT level was defined as 2.6 to 5.0 times the ULN. Grade 3 ALT level was defined as 5.1 to 10.0 times the ULN. Grade 4 ALT level was defined as \> 10.0 times the ULN.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=58 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=53 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=57 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=58 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
30D+W14, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
30D+W14, Missing
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
7D+W6, Normal
|
56 Participants
|
55 Participants
|
51 Participants
|
55 Participants
|
55 Participants
|
52 Participants
|
56 Participants
|
57 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
7D+W6, Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
7D+W6, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
7D+W6, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
7D+W6, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
7D+W6, Missing
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
30D+W14, Normal
|
48 Participants
|
49 Participants
|
49 Participants
|
52 Participants
|
52 Participants
|
47 Participants
|
51 Participants
|
50 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
30D+W14, Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
30D+W14, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
30D+W14, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
This outcome measure concerns biochemical abnormalities, for the creatinine (CREA) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal CREA level was defined as CREA ≤ 106, 88 and 71 micromoles per liter (µmol/L) for subjects 1, 2 or ≥ 2 days of age, respectively. Grade 1 CREA level was defined as 1.1 to 1.3 times the upper limit of normal (ULN). Grade 2 CREA level was defined as 1.4 to 1.8 times the ULN. Grade 3 CREA level was defined as 1.9 to 3.4 times the ULN. Grade 4 CREA level was defined as ≥ 3.5 times the ULN.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=58 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=53 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=57 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=58 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
7D+W6, Normal
|
55 Participants
|
55 Participants
|
53 Participants
|
57 Participants
|
57 Participants
|
53 Participants
|
57 Participants
|
56 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
7D+W6, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
7D+W6, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
7D+W6, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
30D+W14, Normal
|
50 Participants
|
49 Participants
|
50 Participants
|
52 Participants
|
53 Participants
|
47 Participants
|
51 Participants
|
50 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
30D+W14, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
30D+W14, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
30D+W14, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
30D+W14, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
30D+W14, Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
7D+W6, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
7D+W6, Missing
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
This outcome measure concerns haematological abnormalities, for the haemoglobin (HAE) parameter. Subjects' levels were assessed as either normal, Grade (G) 1, G 2, G 3, G 4 or Missing. Normal HAE level was defined as HAE \> 13.0 and 10.5 grams per deciliter (g/dL) for subjects aged 1 to 21 and 22 to 35 days respectively. Grades were defined as follows: 1) In subjects aged 1 to 21 days: G1 = HAE as 12.0 to 13.0 g/dL, G2 = HAE as 10.0 to 11.9 g/dL, G3 = HAE as 9.0 to 9.9 g/dL, G4 = HAE \< 9.0 g/dL; 2) In subjects aged 22 to 35 days: G1 = HAE as 9.5 to 10.5 g/dL, G2 = HAE as 8.0 to 9.4 g/dL, G3 = HAE as 7.0 to 7.9 g/dL, G4 = HAE \< 7.0 g/dL; 3) In subjects aged 36 to 56 days: G1 = HAE as 8.5 to 9.4 g/dL, G2 = HAE as 7.0 to 8.4 g/dL, G3 = HAE as 6.0 to 6.9 g/dL, G4 = HAE \< 6.0 g/dL; 4) In subjects aged ≥ 57 days: G1 = HAE as 10.0 to 10.9 g/dL, G2 = HAE as 9.0 to 9.9 g/dL, G3 = HAE as 7.0 to 8.9 g/dL, G4 = HAE \< 7.0 g/dL.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=58 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=53 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=57 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=58 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
7D+W6, Grade 1
|
1 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
21 Participants
|
3 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
7D+W6, Grade 2
|
5 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
7D+W6, Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
7D+W6, Missing
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
30D+W14, Grade 2
|
7 Participants
|
11 Participants
|
10 Participants
|
13 Participants
|
11 Participants
|
18 Participants
|
12 Participants
|
6 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
30D+W14, Grade 3
|
3 Participants
|
6 Participants
|
0 Participants
|
7 Participants
|
4 Participants
|
8 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
30D+W14, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
7D+W6, Normal
|
51 Participants
|
47 Participants
|
43 Participants
|
50 Participants
|
48 Participants
|
45 Participants
|
25 Participants
|
48 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
30D+W14, Normal
|
25 Participants
|
17 Participants
|
23 Participants
|
15 Participants
|
12 Participants
|
6 Participants
|
15 Participants
|
20 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
30D+W14, Grade 1
|
16 Participants
|
15 Participants
|
16 Participants
|
18 Participants
|
26 Participants
|
15 Participants
|
19 Participants
|
24 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
30D+W14, Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
7D+W6, Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
This outcome measure concerns haematological abnormalities, for the platelets (PLA) parameter. Subjects' levels were assessed as either normal, Grade (G) 1, G2, G3, G4 or Missing. Normal PLA level was defined as \> 125 x 10 exp 9 PLA per liter (Billions PLA/L). Grade 1 PLA level was defined as 100 to 125 Billions PLA/L. Grade 2 PLA level was defined as 50 to 99 Billions PLA/L. Grade 3 PLA level was defined as 25 to 49 Billions PLA/L. Grade 4 PLA level was defined as \< 25 Billions PLA/L.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=58 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=53 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=57 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=58 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
7D+W6, Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
7D+W6, Grade 2
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
7D+W6, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
7D+W6, Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
7D+W6, Missing
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
30D+W14, Normal
|
51 Participants
|
49 Participants
|
46 Participants
|
53 Participants
|
51 Participants
|
45 Participants
|
53 Participants
|
51 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
30D+W14, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
30D+W14, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
30D+W14, Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
7D+W6, Normal
|
54 Participants
|
55 Participants
|
47 Participants
|
55 Participants
|
57 Participants
|
53 Participants
|
57 Participants
|
51 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
30D+W14, Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
30D+W14, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
This outcome measure concerns haematological abnormalities, for the white blood cells (WBC) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal WBC level was defined as \> 2.5 x 10 exp 9 WBC per liter (Billions WBC/L). Grade 1 WBC level was defined as 2.0 to 2.5 Billions WBC/L. Grade 2 WBC level was defined as 1.5 to 1.999 Billions WBC/L. Grade 3 WBC level was defined as 1.0 to 1.499 Billions WBC/L. Grade 4 WBC level was defined as \< 1.0 Billions WBC/L.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=58 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=53 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=57 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=58 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
7D+W6, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
7D+W6, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
7D+W6, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
7D+W6, Missing
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
30D+W14, Normal
|
51 Participants
|
49 Participants
|
50 Participants
|
53 Participants
|
53 Participants
|
47 Participants
|
54 Participants
|
52 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
7D+W6, Normal
|
57 Participants
|
57 Participants
|
50 Participants
|
56 Participants
|
57 Participants
|
54 Participants
|
57 Participants
|
58 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
7D+W6, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
30D+W14, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
30D+W14, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
30D+W14, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
30D+W14, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
30D+W14, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Screening (SCR), at Month (M) 4, at M5, at M7 and/or at M10, according to the vaccination scheduling for the specific group assessed concerned groupPopulation: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value for the assay was greater than or equal to (≥) 0.5 EL.U/mL.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=47 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=43 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=45 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=46 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=45 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=44 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=51 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=48 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS, at M4
|
33.6 EL.U/mL
Interval 18.5 to 61.3
|
72.8 EL.U/mL
Interval 44.6 to 118.7
|
112.2 EL.U/mL
Interval 76.0 to 165.8
|
99.7 EL.U/mL
Interval 61.3 to 162.0
|
88.0 EL.U/mL
Interval 55.4 to 139.8
|
—
|
—
|
0 EL.U/mL
Interval 0.0 to 0.0
|
|
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS, at SCR
|
0.5 EL.U/mL
Interval 0.4 to 0.7
|
0.4 EL.U/mL
Interval 0.3 to 0.5
|
0.4 EL.U/mL
Interval 0.3 to 0.5
|
0.4 EL.U/mL
Interval 0.3 to 0.5
|
0.4 EL.U/mL
Interval 0.3 to 0.6
|
0.4 EL.U/mL
Interval 0.3 to 0.5
|
0.4 EL.U/mL
Interval 0.3 to 0.5
|
0.5 EL.U/mL
Interval 0.4 to 0.7
|
|
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS, at M5
|
128.2 EL.U/mL
Interval 92.2 to 178.2
|
—
|
218.3 EL.U/mL
Interval 160.1 to 297.6
|
—
|
—
|
167.6 EL.U/mL
Interval 133.2 to 210.9
|
—
|
0 EL.U/mL
Interval 0.0 to 0.0
|
|
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS, at M7
|
—
|
136.6 EL.U/mL
Interval 93.0 to 200.7
|
—
|
156.5 EL.U/mL
Interval 100.4 to 244.0
|
170.6 EL.U/mL
Interval 114.6 to 254.1
|
392.6 EL.U/mL
Interval 323.3 to 476.7
|
141.7 EL.U/mL
Interval 97.0 to 207.1
|
0 EL.U/mL
Interval 0.0 to 0.0
|
|
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS, at M10
|
13.8 EL.U/mL
Interval 8.5 to 22.6
|
39.5 EL.U/mL
Interval 22.4 to 69.6
|
30.1 EL.U/mL
Interval 18.8 to 48.2
|
44.2 EL.U/mL
Interval 23.8 to 82.2
|
43.3 EL.U/mL
Interval 24.6 to 76.0
|
121.0 EL.U/mL
Interval 89.4 to 163.7
|
269.9 EL.U/mL
Interval 183.3 to 397.5
|
0.3 EL.U/mL
Interval 0.2 to 0.4
|
SECONDARY outcome
Timeframe: At Screening (SCR), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10), according to the vaccination schedulingPopulation: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-off values for the assay were greater than or equal to (≥) 6.2 and 10 mIU/mL, respectively.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=33 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=37 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=37 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=38 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=37 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=34 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=37 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=38 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations.
SCR
|
10.7 mIU/mL
Interval 4.2 to 27.3
|
22.2 mIU/mL
Interval 6.6 to 74.6
|
9.9 mIU/mL
Interval 4.4 to 22.0
|
9.5 mIU/mL
Interval 4.4 to 20.6
|
17.2 mIU/mL
Interval 7.1 to 41.8
|
12.6 mIU/mL
Interval 4.9 to 32.0
|
38.6 mIU/mL
Interval 13.6 to 109.5
|
22.6 mIU/mL
Interval 8.5 to 59.8
|
|
Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations.
M5
|
6479.0 mIU/mL
Interval 3858.9 to 10878.2
|
—
|
3831.6 mIU/mL
Interval 1783.4 to 8232.3
|
—
|
—
|
—
|
—
|
640.7 mIU/mL
Interval 381.3 to 1076.7
|
|
Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations.
M7
|
—
|
23218.5 mIU/mL
Interval 16670.1 to 32339.2
|
—
|
29839.9 mIU/mL
Interval 20731.1 to 42951.0
|
34589.1 mIU/mL
Interval 21299.2 to 56171.6
|
44472.4 mIU/mL
Interval 31305.5 to 63177.1
|
—
|
430.1 mIU/mL
Interval 277.8 to 666.0
|
|
Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations.
M10
|
2949.5 mIU/mL
Interval 2040.5 to 4263.4
|
9630.8 mIU/mL
Interval 6472.2 to 14330.9
|
3135.0 mIU/mL
Interval 2287.6 to 4296.2
|
8581.8 mIU/mL
Interval 5974.8 to 12326.5
|
12084.3 mIU/mL
Interval 8211.6 to 17783.5
|
13360.1 mIU/mL
Interval 8195.5 to 21779.4
|
75018.0 mIU/mL
Interval 54992.1 to 102336.5
|
139.5 mIU/mL
Interval 77.2 to 252.1
|
SECONDARY outcome
Timeframe: At Month 5Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
Anti-D and anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off value for the assay was ≥ 0.1 IU/mL.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=48 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=46 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=45 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=48 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=47 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=44 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=47 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Anti-D
|
3.1 IU/mL
Interval 2.2 to 4.5
|
3.9 IU/mL
Interval 2.9 to 5.3
|
3.2 IU/mL
Interval 2.5 to 4.0
|
4.0 IU/mL
Interval 3.2 to 5.1
|
3.6 IU/mL
Interval 2.7 to 4.8
|
4.3 IU/mL
Interval 3.2 to 5.8
|
4.3 IU/mL
Interval 3.4 to 5.5
|
4.6 IU/mL
Interval 3.7 to 5.6
|
|
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Anti-TT
|
3.5 IU/mL
Interval 2.6 to 4.6
|
3.2 IU/mL
Interval 2.3 to 4.4
|
3.7 IU/mL
Interval 2.8 to 4.8
|
2.8 IU/mL
Interval 2.2 to 3.7
|
3.3 IU/mL
Interval 2.4 to 4.4
|
3.3 IU/mL
Interval 2.4 to 4.6
|
3.5 IU/mL
Interval 2.6 to 4.6
|
4.6 IU/mL
Interval 3.5 to 6.0
|
SECONDARY outcome
Timeframe: At Month 5Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off value for the assay was ≥ 0.15 µg/mL.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=47 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=44 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=44 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=48 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=47 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=43 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=52 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=47 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations
|
6.8 µg/mL
Interval 4.5 to 10.3
|
11.1 µg/mL
Interval 7.5 to 16.5
|
11.4 µg/mL
Interval 7.3 to 17.8
|
13.6 µg/mL
Interval 9.6 to 19.3
|
10.9 µg/mL
Interval 7.4 to 16.0
|
11.0 µg/mL
Interval 7.1 to 16.9
|
15.6 µg/mL
Interval 10.6 to 22.8
|
13.8 µg/mL
Interval 9.7 to 19.5
|
SECONDARY outcome
Timeframe: At Month 5Population: Analysis was done on the According-to-Protocol cohort for immunogenicity included all subjects included in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals and did not take any immune modifying medication or had blood transfusions.
Anti-Polio 1, 2 and 3 antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in international units per mililiter (IU/mL) and tabulated. The seroprotection cut-off value for the assay was ≥ 8 IU/mL.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=31 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=16 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=25 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=25 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=19 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=29 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=25 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=30 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations
Anti-Polio 1
|
27.6 IU/mL
Interval 16.5 to 46.0
|
21.6 IU/mL
Interval 10.3 to 45.2
|
31.7 IU/mL
Interval 17.2 to 58.7
|
47.1 IU/mL
Interval 21.5 to 102.8
|
19.9 IU/mL
Interval 4.0 to 98.3
|
23.6 IU/mL
Interval 8.4 to 66.5
|
16.7 IU/mL
Interval 7.9 to 35.4
|
45.4 IU/mL
Interval 18.9 to 109.4
|
|
Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations
Anti-Polio 2
|
27.5 IU/mL
Interval 16.8 to 45.1
|
35.1 IU/mL
Interval 14.9 to 82.4
|
56.6 IU/mL
Interval 32.8 to 97.7
|
37.9 IU/mL
Interval 17.0 to 84.6
|
42 IU/mL
Interval 21.6 to 81.6
|
27.6 IU/mL
Interval 12.6 to 60.4
|
40.1 IU/mL
Interval 24.1 to 66.6
|
25.9 IU/mL
Interval 16.4 to 40.7
|
|
Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations
Anti-Polio 3
|
3.6 IU/mL
Interval 1.6 to 7.9
|
2.3 IU/mL
Interval 0.6 to 8.7
|
5.1 IU/mL
Interval 2.6 to 10.2
|
3.3 IU/mL
Interval 1.3 to 8.4
|
5.6 IU/mL
Interval 2.6 to 12.2
|
2.6 IU/mL
Interval 1.2 to 5.7
|
3 IU/mL
Interval 1.6 to 5.5
|
6 IU/mL
Interval 3.3 to 10.8
|
SECONDARY outcome
Timeframe: At Month 5Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
Concentrations of anti-BPT antibodies were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value for the assay was ≥ 15 EL.U/mL.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=43 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=42 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=41 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=46 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=42 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=42 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=50 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=41 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Acellular B-pertussis (BPT)
|
82.9 EL.U/mL
Interval 69.9 to 98.4
|
102.3 EL.U/mL
Interval 84.9 to 123.4
|
86.7 EL.U/mL
Interval 72.5 to 103.7
|
81.2 EL.U/mL
Interval 66.7 to 98.8
|
99.2 EL.U/mL
Interval 82.6 to 119.1
|
86.1 EL.U/mL
Interval 71.7 to 103.4
|
91.0 EL.U/mL
Interval 75.9 to 109.0
|
109.8 EL.U/mL
Interval 89.7 to 134.4
|
SECONDARY outcome
Timeframe: At Month 10Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
Concentrations of anti measles antibodies were determined by ELISA and expressed as GMCs in milli-international units per millilitre (mIU/mL). The seropositivity cut-off value for the assay was ≥ 150 mIU/mL. Please note that this outcome measure was only assessed in subjects in the RTS,S 14-26-9M and Engerix-B Neo groups.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=52 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=46 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Measles Antigens
|
1017.7 mIU/mL
Interval 751.9 to 1377.4
|
1430.6 mIU/mL
Interval 996.9 to 2053.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after Week 0 vaccinationPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
Solicited local symptoms assessed include pain, redness and swelling. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=59 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=58 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=60 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=59 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=59 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Pain
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Redness
|
3 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
11 Participants
|
6 Participants
|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Swelling
|
2 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after Week 6 vaccinationPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
Solicited local symptoms assessed include pain, redness and swelling. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=55 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=55 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=57 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=55 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=58 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=51 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Pain
|
2 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Redness
|
3 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Swelling
|
4 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after Week 10 vaccinationPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
Solicited local symptoms assessed include pain, redness and swelling. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=52 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=51 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=56 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=52 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=51 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Pain
|
4 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Redness
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Swelling
|
4 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after Week 14 vaccinationPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
Solicited local symptoms assessed include pain, redness and swelling. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=51 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=53 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=51 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=55 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=50 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=52 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Redness
|
4 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Pain
|
4 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Swelling
|
7 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after Week 26 vaccinationPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
Solicited local symptoms assessed include pain, redness and swelling. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn't receive vaccination at this time point.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=49 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=46 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=56 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after Month 9 vaccinationPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
Solicited local symptoms assessed include pain, redness and swelling. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=50 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=49 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=48 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=51 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=47 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=56 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=51 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Solicited Local Symptoms
Any Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after Week 0 vaccinationPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=59 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=58 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=60 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=59 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=60 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=59 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Solicited General Symptoms
Any Drowsiness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Irritability/Fussiness
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Loss of appetite
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Fever
|
8 Participants
|
9 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after Week 6 vaccinationPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=55 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=55 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=57 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=55 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=58 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=51 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Solicited General Symptoms
Any Drowsiness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Irritability/Fussiness
|
1 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Loss of appetite
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Fever
|
6 Participants
|
9 Participants
|
10 Participants
|
4 Participants
|
10 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after Week 10 vaccinationPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=52 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=51 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=56 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=51 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=51 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Solicited General Symptoms
Any Irritability/Fussiness
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Loss of appetite
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Fever
|
11 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Drowsiness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after Week 14 vaccinationPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=51 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=53 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=51 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=55 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=50 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=57 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=52 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Solicited General Symptoms
Any Drowsiness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Irritability/Fussiness
|
4 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Loss of appetite
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Fever
|
9 Participants
|
5 Participants
|
10 Participants
|
2 Participants
|
2 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after Week 26 vaccinationPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn't receive any vaccination at this time point
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=49 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=46 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=56 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Solicited General Symptoms
Any Drowsiness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Irritability/Fussiness
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Loss of appetite
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Fever
|
8 Participants
|
7 Participants
|
2 Participants
|
7 Participants
|
10 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after Month 9 vaccinationPopulation: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=50 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=49 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=48 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=54 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=51 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=47 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=56 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=51 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported With Solicited General Symptoms
Any Drowsiness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Irritability/Fussiness
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Loss of appetite
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reported With Solicited General Symptoms
Any Fever
|
1 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
10 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Month 18 post vaccinationPopulation: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
Month 18 immunogenicity data were tertiary objectives, and although not required to be disclosed were included in this result summary at the request of the study team to show the full study immunogenicity results.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=45 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=43 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=47 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=47 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=45 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=40 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=52 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=48 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
|
5.1 EL.U/mL
Interval 3.1 to 8.3
|
12.7 EL.U/mL
Interval 7.2 to 22.3
|
12 EL.U/mL
Interval 8.3 to 17.4
|
16.2 EL.U/mL
Interval 9.4 to 28.1
|
14.3 EL.U/mL
Interval 8.7 to 23.6
|
33.8 EL.U/mL
Interval 24.7 to 46.4
|
49.3 EL.U/mL
Interval 36.2 to 67.0
|
0.3 EL.U/mL
Interval 0.2 to 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Month 18 post vaccinationPopulation: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
Month 18 immunogenicity data were tertiary objectives, and although not required to be disclosed were included in this result summary at the request of the study team to show the full study immunogenicity results.
Outcome measures
| Measure |
RTS,S Neo-10-14 Group
n=40 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=41 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=45 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=45 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=43 Participants
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=39 Participants
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=47 Participants
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=42 Participants
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations
|
1656.6 mIU/mL
Interval 1180.1 to 2325.4
|
3509.9 mIU/mL
Interval 2464.8 to 4998.0
|
1823.1 mIU/mL
Interval 1260.6 to 2636.5
|
4208.4 mIU/mL
Interval 3045.5 to 5815.5
|
4725.7 mIU/mL
Interval 3508.7 to 6364.7
|
7341.5 mIU/mL
Interval 5023.1 to 10729.9
|
12045.3 mIU/mL
Interval 8881.5 to 16336.2
|
78 mIU/mL
Interval 44.1 to 137.9
|
Adverse Events
RTS,S Neo-10-14 Group
Serious events: 7 serious events
Other events: 36 other events
Deaths: 0 deaths
RTS,S Neo-10-26 Group
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
RTS,S 6-10-14 Group
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
RTS,S 6-10-26 Group
Serious events: 9 serious events
Other events: 29 other events
Deaths: 0 deaths
Engerix-B Neo/RTS,S 6-10-26 Group
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
RTS,S 10-14-26 Group
Serious events: 12 serious events
Other events: 36 other events
Deaths: 1 deaths
RTS,S 14-26-9M Group
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
Engerix-B Neo Group
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RTS,S Neo-10-14 Group
n=60 participants at risk
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=59 participants at risk
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=58 participants at risk；n=60 participants at risk
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=60 participants at risk
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=60 participants at risk
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=59 participants at risk；n=60 participants at risk
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=60 participants at risk
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=59 participants at risk；n=60 participants at risk
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
6.7%
4/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.3%
2/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.3%
2/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
6.7%
4/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
8.3%
5/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.3%
2/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Bronchiolitis
|
3.3%
2/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.1%
3/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.3%
2/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.3%
2/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Pneumonia
|
3.3%
2/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.3%
2/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.0%
3/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.3%
2/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
General disorders
Pyrexia
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Malaria
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Abscess
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Cerebral malaria
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
General disorders
Drowning
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Ear infection
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Escherichia sepsis
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Meningitis neonatal
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Meningitis pneumococcal
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Oral candidiasis
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Viral infection
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
Other adverse events
| Measure |
RTS,S Neo-10-14 Group
n=60 participants at risk
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S Neo-10-26 Group
n=59 participants at risk
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-14 Group
n=58 participants at risk；n=60 participants at risk
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 6-10-26 Group
n=60 participants at risk
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo/RTS,S 6-10-26 Group
n=60 participants at risk
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 10-14-26 Group
n=59 participants at risk；n=60 participants at risk
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
RTS,S 14-26-9M Group
n=60 participants at risk
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
Engerix-B Neo Group
n=59 participants at risk；n=60 participants at risk
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
5.0%
3/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.4%
2/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
9.3%
5/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.8%
1/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
8.8%
5/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.8%
2/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.3%
3/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.9%
1/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.4%
2/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.6%
3/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.5%
2/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.3%
3/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.9%
1/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.5%
2/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.8%
2/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.9%
1/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.3%
3/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.5%
2/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Conjunctivitis
|
6.7%
4/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
8.5%
5/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.9%
1/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.5%
2/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.5%
2/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
11.5%
6/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
8.8%
5/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.8%
2/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
3/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
8.5%
5/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.3%
3/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.5%
2/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
17.3%
9/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
14.0%
8/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.8%
2/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Malaria
|
8.3%
5/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.1%
3/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.7%
2/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
7.0%
4/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
9.6%
5/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
15.8%
9/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
6/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.1%
3/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
11.1%
6/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.5%
6/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.3%
3/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.8%
3/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
12.3%
7/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
13.5%
7/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Oral candidiasis
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.1%
3/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.8%
1/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.9%
1/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.8%
1/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Pneumonia
|
13.3%
8/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.2%
6/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.6%
3/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
12.3%
7/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.5%
6/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
9.6%
5/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
15.8%
9/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
11.5%
6/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Respiratory tract infection
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.4%
2/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.3%
3/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.8%
1/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.8%
1/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Infections and infestations
Upper respiratory tract infection
|
18.3%
11/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
25.4%
15/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
18.5%
10/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.5%
6/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
19.3%
11/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
25.0%
13/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
26.3%
15/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
25.0%
13/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
2/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.4%
2/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.6%
3/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
8.8%
5/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.8%
2/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
7.0%
4/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.8%
3/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
4/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.4%
2/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
0.00%
0/54 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.5%
2/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.3%
3/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
9.6%
5/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.5%
2/57 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.8%
2/52 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
General disorders
Pain
|
6.7%
4/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
8.5%
5/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
12.1%
7/58 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
11.7%
7/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
6.7%
4/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.2%
6/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
8.3%
5/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.2%
6/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
General disorders
Redness
|
6.7%
4/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
8.5%
5/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.3%
6/58 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.0%
6/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
11.7%
7/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
8.5%
5/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
18.3%
11/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.2%
6/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
General disorders
Swelling
|
11.7%
7/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
8.5%
5/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.3%
6/58 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
13.3%
8/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.0%
6/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.2%
6/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
13.3%
8/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.2%
6/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
General disorders
Irritability
|
6.7%
4/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.4%
2/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.3%
6/58 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.0%
3/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
5.1%
3/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
1.7%
1/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
3.4%
2/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
|
General disorders
Fever (axillary temperature >= 37.5°C)
|
18.3%
11/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
15.3%
9/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
17.2%
10/58 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
10.0%
6/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
16.7%
10/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
16.9%
10/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
16.7%
10/60 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
15.3%
9/59 • Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
|
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