Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001508-37 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated into an Expanded Program on Immunization (EPI) regimen to infants living in sub-Saharan Africa.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RTS,S Regimen A Lot 1 Group | Experimental | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen A, with the RTS,S vaccine administered in its Lot 1 formulation. This RTS,S Vaccination Regimen A included 3 doses of RTS,S vaccine, Lot 1, co-administered with Infanrixâ„¢-Hib, Polio Sabinâ„¢ and Synflorixâ„¢, at Weeks 0, 4 and 8, and 2 doses of Rotarixâ„¢ vaccine, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrixâ„¢-Hib and Synflorixâ„¢, at Month 16, and one booster dose of Engerix Bâ„¢ vaccine, at Month 50. The RTS,S vaccine and Engerix Bâ„¢ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrixâ„¢-Hib IM in the right deltoid, Synflorixâ„¢ IM in the right anterolateral thigh, and Rotarixâ„¢ and Polio Sabinâ„¢ orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
| RTS,S Regimen A Lot 2 Group | Experimental | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen A, with the RTS,S vaccine administered in its Lot 2 formulation. This RTS,S Vaccination Regimen A included 3 doses of RTS,S vaccine, Lot 2, co-administered with Infanrixâ„¢-Hib, Polio Sabinâ„¢ and Synflorixâ„¢, at Weeks 0, 4 and 8, and 2 doses of Rotarixâ„¢ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrixâ„¢-Hib and Synflorixâ„¢, at Month 16, and one booster dose of Engerix Bâ„¢ vaccine, at Month 50. The RTS,S vaccine and Engerix Bâ„¢ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrixâ„¢-Hib IM in the right deltoid, Synflorixâ„¢ IM in the right anterolateral thigh, and Rotarixâ„¢ and Polio Sabinâ„¢ orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 | Biological | Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Seroprotected Subjects Against Anti-Hepatitis B (HBs) Antigen | A seroprotected subject was defined as a subject with anti-HBs antibody titers greater than or equal to (>=) the cut-off of 10 mili-international units per mililiter (mIU/mL). A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix -B). | At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B |
| Anti-Hepatitis B (HBs) Antibody Concentrations for RTS,S Group and Engerix B Group | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix-B). | At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B |
| Anti-Hepatitis B (HBs) Antibody Concentrations for All Study Groups | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, for each RTS,S Regimen A, B, C and each Engerix B Regimen A and B study groups. | At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-Hepatitis B (HBs) Antibody Concentrations at Month 3 | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for the study groups receiving the RTS,S vaccine, pooled by vaccine lot, that is, for the RTS,S Lot 1, RTS,S Lot 2, and RTS,S Lot 3 groups, as defined below. |
Not provided
Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ouagadougou | Burkina Faso | ||||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29630438 | Background | Valea I, Adjei S, Usuf E, Traore O, Ansong D, Tinto H, Owusu Boateng H, Leach A, Mwinessobaonfou Some A, Buabeng P, Vekemans J, Nana LA, Kotey A, Vandoolaeghe P, Ouedraogo F, Sambian D, Lievens M, Tahita MC, Rettig T, Jongert E, Lompo P, Idriss A, Borys D, Ouedraogo S, Prempeh F, Habib MA, Schuerman L, Sorgho H, Agbenyega T. Immune response to the hepatitis B antigen in the RTS,S/AS01 malaria vaccine, and co-administration with pneumococcal conjugate and rotavirus vaccines in African children: A randomized controlled trial. Hum Vaccin Immunother. 2018 Jun 3;14(6):1489-1500. doi: 10.1080/21645515.2018.1442996. Epub 2018 Apr 13. |
| Label | URL |
|---|---|
| IPD for this study will be made available via the Clinical Study Data Request site. | View source |
Not provided
IPD is available via the Clinical Study Data Request site (click on the link provided below).
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Not provided
The study was conducted in 4 phases, a Primary Vaccination Phase (up to Month (M) 3), a Safety Follow-Up Phase (M3-8), a First Immunogenicity Follow-Up (FU) Phase (M8-26), and a Second Immunogenicity FU Phase (M26 to study end at M51).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RTS,S Regimen A Group | This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2014 | May 29, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| RTS,S Regimen A Lot 3 Group | Experimental | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen A, with the RTS,S vaccine administered in its Lot 3 formulation. This RTS,S Vaccination Regimen A included 3 doses of RTS,S vaccine, Lot 3, co-administered with Infanrixâ„¢-Hib, Polio Sabinâ„¢ and Synflorixâ„¢, at Weeks 0, 4 and 8, and 2 doses of Rotarixâ„¢ vaccine, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrixâ„¢-Hib and Synflorixâ„¢, at Month 16, and one booster dose of Engerix Bâ„¢ vaccine, at Month 50. The RTS,S vaccine and Engerix Bâ„¢ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrixâ„¢-Hib IM in the right deltoid, Synflorixâ„¢ IM in the right anterolateral thigh, and Rotarixâ„¢ and Polio Sabinâ„¢ orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
| RTS,S Regimen B Lot 1 Group | Experimental | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen B, with the RTS,S vaccine administered in its Lot 1 formulation. This RTS,S Vaccination Regimen B included 3 doses of RTS,S vaccine, Lot 1, co-administered with Infanrixâ„¢-Hib and Polio Sabinâ„¢, at Weeks 0, 4 and 8, 2 doses of Rotarixâ„¢, at Weeks 4 and 8, and 3 doses of Synflorixâ„¢ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrixâ„¢-Hib and Synflorixâ„¢, at Month 16, and one booster dose of Engerix Bâ„¢ vaccine, at Month 50. The RTS,S vaccine and Engerix Bâ„¢ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrixâ„¢-Hib IM in the right deltoid, Synflorixâ„¢ IM in the right anterolateral thigh, and Rotarixâ„¢ and Polio Sabinâ„¢ orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
| RTS,S Regimen B Lot 2 Group | Experimental | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen B, with the RTS,S vaccine administered in its Lot 2 formulation. This RTS,S Vaccination Regimen B included 3 doses of RTS,S vaccine, Lot 2, co-administered with Infanrixâ„¢-Hib and Polio Sabinâ„¢, at Weeks 0, 4 and 8, 2 doses of Rotarixâ„¢, at Weeks 4 and 8, and 3 doses of Synflorixâ„¢ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrixâ„¢-Hib and Synflorixâ„¢, at Month 16, and one booster dose of Engerix Bâ„¢ vaccine, at Month 50. The RTS,S vaccine and Engerix Bâ„¢ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrixâ„¢-Hib IM in the right deltoid, Synflorixâ„¢ IM in the right anterolateral thigh, and Rotarixâ„¢ and Polio Sabinâ„¢ orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
| RTS,S Regimen B Lot 3 Group | Experimental | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen B, with the RTS,S vaccine administered in its Lot 3 formulation. This RTS,S Vaccination Regimen B included 3 doses of RTS,S vaccine, Lot 3, co-administered with Infanrixâ„¢-Hib and Polio Sabinâ„¢, at Weeks 0, 4 and 8, 2 doses of Rotarixâ„¢, at Weeks 4 and 8, and 3 doses of Synflorixâ„¢ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrixâ„¢-Hib and Synflorixâ„¢, at Month 16, and one booster dose of Engerix Bâ„¢ vaccine, at Month 50. The RTS,S vaccine and Engerix Bâ„¢ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrixâ„¢-Hib IM in the right deltoid, Synflorixâ„¢ IM in the right anterolateral thigh, and Rotarixâ„¢ and Polio Sabinâ„¢ orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
| RTS,S Regimen C Lot 1 Group | Experimental | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen C, with the RTS,S vaccine administered in its Lot 1 formulation. This RTS,S Vaccination Regimen C included 3 doses of RTS,S vaccine, Lot 1, co-administered with Infanrixâ„¢-Hib and Polio Sabinâ„¢, at Weeks 0, 4 and 8, 2 doses of Rotarixâ„¢, at Weeks 6 and 10, and 3 doses of Synflorixâ„¢ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrixâ„¢-Hib and Synflorixâ„¢, at Month 16, and one booster dose of Engerix Bâ„¢ vaccine, at Month 50. The RTS,S vaccine and Engerix Bâ„¢ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrixâ„¢-Hib IM in the right deltoid, Synflorixâ„¢ IM in the right anterolateral thigh, and Rotarixâ„¢ and Polio Sabinâ„¢ orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
| RTS,S Regimen C Lot 2 Group | Experimental | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen C, with the RTS,S vaccine administered in its Lot 2 formulation. This RTS,S Vaccination Regimen C included 3 doses of RTS,S vaccine, Lot 2, co-administered with Infanrixâ„¢-Hib and Polio Sabinâ„¢, at Weeks 0, 4 and 8, 2 doses of Rotarixâ„¢, at Weeks 6 and 10, and 3 doses of Synflorixâ„¢ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrixâ„¢-Hib and Synflorixâ„¢, at Month 16, and one booster dose of Engerix Bâ„¢ vaccine, at Month 50. The RTS,S vaccine and Engerix Bâ„¢ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrixâ„¢-Hib IM in the right deltoid, Synflorixâ„¢ IM in the right anterolateral thigh, and Rotarixâ„¢ and Polio Sabinâ„¢ orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
| RTS,S Regimen C Lot 3 Group | Experimental | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen C, with the RTS,S vaccine administered in its Lot 3 formulation. This RTS,S Vaccination Regimen C included 3 doses of RTS,S vaccine, Lot 3, co-administered with Infanrixâ„¢-Hib and Polio Sabinâ„¢, at Weeks 0, 4 and 8, 2 doses of Rotarixâ„¢, at Weeks 6 and 10, and 3 doses of Synflorixâ„¢ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrixâ„¢-Hib and Synflorixâ„¢, at Month 16, and one booster dose of Engerix Bâ„¢ vaccine, at Month 50. The RTS,S vaccine and Engerix Bâ„¢ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrixâ„¢-Hib IM in the right deltoid, Synflorixâ„¢ IM in the right anterolateral thigh, and Rotarixâ„¢ and Polio Sabinâ„¢ orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
| Engerix B Regimen A Group | Active Comparator | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix Bâ„¢ co-administered with Infanrixâ„¢-Hib, Polio Sabinâ„¢ and Synflorixâ„¢ at Weeks 0, 4 and 8, and 2 doses of Rotarixâ„¢, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrixâ„¢-Hib and Synflorixâ„¢, at Month 16, and one booster dose of Engerix Bâ„¢ vaccine, at Month 50. Engerix Bâ„¢ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrixâ„¢-Hib IM in the right deltoid, Synflorixâ„¢ IM in the right anterolateral thigh, and Rotarixâ„¢ and Polio Sabinâ„¢ orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
| Engerix B Regimen B Group | Active Comparator | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix Bâ„¢ co-administered with Infanrixâ„¢-Hib and Polio Sabinâ„¢, at Weeks 0, 4 and 8, 2 doses of Rotarixâ„¢ vaccine, at Weeks 4 and 8, and 3 doses of Synflorixâ„¢ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrixâ„¢-Hib and Synflorixâ„¢, at Month 16, and one booster dose of Engerix Bâ„¢ vaccine, at Month 50. Engerix Bâ„¢ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrixâ„¢-Hib IM in the right deltoid, Synflorixâ„¢ IM in the right anterolateral thigh, and Rotarixâ„¢ and Polio Sabinâ„¢ orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
| Engerix-Bâ„¢ vaccine | Biological | Children enrolled in 2 groups will receive 4 doses of Engerix-Bâ„¢ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection. |
|
| Infanrix/Hibâ„¢ vaccine | Biological | Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hibâ„¢ vaccine by intramuscular injection |
|
| Polio Sabinâ„¢ vaccine | Biological | Children enrolled in all 11 groups will receive 3 doses of Polio Sabinâ„¢ by intramuscular injection. |
|
| Rotarixâ„¢ vaccine | Biological | Children enrolled in all 11 groups will receive 2 doses of oral Rotarixâ„¢ vaccine. |
|
| Synflorixâ„¢ vaccine | Biological | Children enrolled in all 11 groups will receive 4 doses of Synflorixâ„¢ vaccine by intramuscular injection. |
|
| Measles vaccine | Biological | Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection. |
|
| Yellow fever vaccine | Biological | Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection. |
|
| At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B |
| Anti-Hepatitis B (HBs) Antibody Concentrations at Month 14 and 26 | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. | At Months 14 and 26, aka at 12 and 24 months post Dose 3 of RTS,S vaccine or Engerix-B |
| Anti-Hepatitis B (HBs) Antibody Concentrations at Month 38, 50 and 51 | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. | At Months 38, 50 and 51, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B and one month post the Month 50 booster dose of Engerix-B |
| Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1) at Month 3 | Anti-HBs RF1 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. | At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B |
| Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1) at Month 51 | Anti-HBs RF1 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. | At Month 51, aka one month post the Month 50 booster dose of Engerix-B |
| Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 3 | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. | At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B |
| Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 14 | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. No anti-CS results are available for the time point 24 months post Dose 3 (Month 26) because the quantity of serum available for the anti-CS assay was insufficient for many samples. | At Month 14, aka at 12 months post Dose 3 of RTS,S vaccine or Engerix-B |
| Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 38 and 50 | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 1.9 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. | At Months 38 and 50, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B |
| Pneumococcal Antibody Concentrations Against Synflorix Pneumococcal Vaccine Serotypes at Month 3 | Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 µg/mL. This corresponds to the standard ELISA value of 0.35 μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups. | At Month 3, aka at one month post Dose 3 of Synflorix |
| Pneumococcal Antibody Concentrations Against Synflorix Pneumococcal Vaccine Serotypes at Month 17 | Antibody concentrations were measured by GSK assay, and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 μg/mL. This corresponds to the standard ELISA value of 0.35 μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups. | At Month 17, aka one month post the Month 16 booster dose of Synflorix |
| Titers for Opsonophagocytic Activity Against Synflorix Pneumococcal Vaccine Serotypes at Month 3 | The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups. | At Month 3, aka at one month (1M) post Dose 3 of Synflorix |
| Titers for Opsonophagocytic Activity Against Synflorix Pneumococcal Vaccine Serotypes at Month 17 | The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix . Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups. | At Month 17, aka one month post the Month 16 booster dose of Synflorix |
| Anti-protein D (PD) Antibody Concentrations at Month 3 | Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups. | At Month 3, aka at one month post Dose 3 of Synflorix |
| Anti-protein D (PD) Antibody Concentrations at Month 17 | Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups. | At Month 17, aka one month post the Month 16 booster dose of Synflorix |
| Concentrations of Antibodies Against Acellular B-pertussis (BPT) at Day 0 and at Month 3 | The antibodies against BPT assessed were against pertussis toxoid (anti-PT), against filamentous haemagglutinin (anti-FHA), and against pertactin (anti-PRN). Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to (>=) 5 EL.U/mL. The table shows results for study groups pooled by primary vaccine administered (RTS,S vs Engerix -B) | At Day 0 and at Month 3 (one month post Dose 3 of Infanrix-Hib) |
| Anti-Rotavirus (Anti-RV) Antibody Concentrations | Anti-Rotavirus (anti-RV) antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs). The cut-off of the assay was the seropositive cut-off value of greater than or equal to (>=) 20 units per milliliter (U/mL). This outcome measure was assessed in subjects who were administered Rotarix as part of an EPI regimen, with and without RTS,S vaccine co-administration. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Rotarix. Results presented are for the study groups pooled by RTS,S or Engerix-B vaccine co-administration, that is, for the RTS,S Regimen B and Engerix-B Regimen B groups. | At Month 3, aka one month post Dose 2 of Rotarix |
| Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling at the site of injection. All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination. Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited local symptoms, that is, the occurrences of these symptoms regardless of their intensity grade. | Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B vaccine |
| Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Fever was defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited general symptoms, that is, the occurrences of these symptoms regardless of their intensity grade or relationship to vaccination. | Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B vaccine |
| Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 to Month 8 | A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis. | From Day 0 to Month 8 |
| Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 to Month 26 | A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis. | From Day 0 to Month 26 |
| Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 up to Study End (Month 51) | A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis. | From Day 0 up to Study End (Month 51) |
| Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B |
| Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) Within the 30-day Follow-up Periods (Days 0-29) | A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject. | Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B |
| Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) From Day 0 to Month 8 | A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject. | From Day 0 to Month 8 |
| Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) From Day 0 to Month 26 | A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject. | From Day 0 to Month 26 |
| Number of Subjects With Any, Fatal and Related Serious Adverse Events (SAEs) From Day 0 up to Study End (Month 51) | A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject. A related SAE was defined as a SAE assessed by the investigator as being causally related to vaccination. | From Day 0 up to Study End (Month 51) |
| Kumasi |
| Ghana |
| FG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| FG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| FG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| FG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RTS,S Regimen A Group | This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| BG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| BG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| BG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| BG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Weeks |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Seroprotected Subjects Against Anti-Hepatitis B (HBs) Antigen | A seroprotected subject was defined as a subject with anti-HBs antibody titers greater than or equal to (>=) the cut-off of 10 mili-international units per mililiter (mIU/mL). A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix -B). | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Anti-Hepatitis B (HBs) Antibody Concentrations for RTS,S Group and Engerix B Group | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix-B). | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Anti-Hepatitis B (HBs) Antibody Concentrations for All Study Groups | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, for each RTS,S Regimen A, B, C and each Engerix B Regimen A and B study groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-Hepatitis B (HBs) Antibody Concentrations at Month 3 | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for the study groups receiving the RTS,S vaccine, pooled by vaccine lot, that is, for the RTS,S Lot 1, RTS,S Lot 2, and RTS,S Lot 3 groups, as defined below. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-Hepatitis B (HBs) Antibody Concentrations at Month 14 and 26 | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Months 14 and 26, aka at 12 and 24 months post Dose 3 of RTS,S vaccine or Engerix-B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-Hepatitis B (HBs) Antibody Concentrations at Month 38, 50 and 51 | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Months 38, 50 and 51, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B and one month post the Month 50 booster dose of Engerix-B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1) at Month 3 | Anti-HBs RF1 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1) at Month 51 | Anti-HBs RF1 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 51, aka one month post the Month 50 booster dose of Engerix-B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 3 | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 14 | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. No anti-CS results are available for the time point 24 months post Dose 3 (Month 26) because the quantity of serum available for the anti-CS assay was insufficient for many samples. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 14, aka at 12 months post Dose 3 of RTS,S vaccine or Engerix-B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 38 and 50 | 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 assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 1.9 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 38 and 50, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pneumococcal Antibody Concentrations Against Synflorix Pneumococcal Vaccine Serotypes at Month 3 | Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 µg/mL. This corresponds to the standard ELISA value of 0.35 μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Month 3, aka at one month post Dose 3 of Synflorix |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pneumococcal Antibody Concentrations Against Synflorix Pneumococcal Vaccine Serotypes at Month 17 | Antibody concentrations were measured by GSK assay, and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 μg/mL. This corresponds to the standard ELISA value of 0.35 μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | At Month 17, aka one month post the Month 16 booster dose of Synflorix |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Titers for Opsonophagocytic Activity Against Synflorix Pneumococcal Vaccine Serotypes at Month 3 | The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Month 3, aka at one month (1M) post Dose 3 of Synflorix |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Titers for Opsonophagocytic Activity Against Synflorix Pneumococcal Vaccine Serotypes at Month 17 | The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix . Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Month 17, aka one month post the Month 16 booster dose of Synflorix |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-protein D (PD) Antibody Concentrations at Month 3 | Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 3, aka at one month post Dose 3 of Synflorix |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-protein D (PD) Antibody Concentrations at Month 17 | Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 17, aka one month post the Month 16 booster dose of Synflorix |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Concentrations of Antibodies Against Acellular B-pertussis (BPT) at Day 0 and at Month 3 | The antibodies against BPT assessed were against pertussis toxoid (anti-PT), against filamentous haemagglutinin (anti-FHA), and against pertactin (anti-PRN). Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to (>=) 5 EL.U/mL. The table shows results for study groups pooled by primary vaccine administered (RTS,S vs Engerix -B) | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Day 0 and at Month 3 (one month post Dose 3 of Infanrix-Hib) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-Rotavirus (Anti-RV) Antibody Concentrations | Anti-Rotavirus (anti-RV) antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs). The cut-off of the assay was the seropositive cut-off value of greater than or equal to (>=) 20 units per milliliter (U/mL). This outcome measure was assessed in subjects who were administered Rotarix as part of an EPI regimen, with and without RTS,S vaccine co-administration. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Rotarix. Results presented are for the study groups pooled by RTS,S or Engerix-B vaccine co-administration, that is, for the RTS,S Regimen B and Engerix-B Regimen B groups. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | U/mL | At Month 3, aka one month post Dose 2 of Rotarix |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling at the site of injection. All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination. Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited local symptoms, that is, the occurrences of these symptoms regardless of their intensity grade. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled-in. | Posted | Count of Participants | Participants | Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B vaccine |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Fever was defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited general symptoms, that is, the occurrences of these symptoms regardless of their intensity grade or relationship to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled-in. | Posted | Count of Participants | Participants | Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B vaccine |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 to Month 8 | A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | From Day 0 to Month 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 to Month 26 | A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | From Day 0 to Month 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 up to Study End (Month 51) | A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | From Day 0 up to Study End (Month 51) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) Within the 30-day Follow-up Periods (Days 0-29) | A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) From Day 0 to Month 8 | A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | From Day 0 to Month 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) From Day 0 to Month 26 | A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | From Day 0 to Month 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any, Fatal and Related Serious Adverse Events (SAEs) From Day 0 up to Study End (Month 51) | A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject. A related SAE was defined as a SAE assessed by the investigator as being causally related to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | From Day 0 up to Study End (Month 51) |
|
Solicited local, general symptoms and unsolicited AEs: within the 30-day periods after primary co-administration vaccination. SAEs: during the entire study period (Month 0 to Month 51).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RTS,S Regimen A Group | This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. | 3 | 142 | 3 | 142 | 135 | 142 |
| EG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. | 5 | 142 | 10 | 142 | 129 | 142 |
| EG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. | 4 | 141 | 9 | 141 | 132 | 141 |
| EG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. | 2 | 141 | 6 | 141 | 135 | 141 |
| EG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. | 1 | 139 | 6 | 139 | 119 | 139 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Intravascular haemolysis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Glucose-6-phosphate dehydrogenase deficiency | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Meningitis streptococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Salmonella sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Trichomoniasis intestinal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Allergic bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Anal fungal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bullous impetigo | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Dysentery | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Excessive cerumen production | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastrointestinal candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Parasitic gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pyoderma | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract malformation | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Visceral larva migrans | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D016778 | Malaria, Falciparum |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C023768 | halofantrine |
| D008458 | Measles Vaccine |
| D022341 | Yellow Fever Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| OG001 | Engerix B Group | Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups who were administered Engerix B as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix and of vaccines against yellow fever and against measles. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Lot 2 Group | Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix, Engerix B and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Lot 3 Group | Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix, Engerix B and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
|
| OG001 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | Engerix B Group | Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups were administered Engerix B as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix and of vaccines against yellow fever and against measles. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
|
| OG001 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
| OG001 | RTS,S Regimen B Group | This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG002 | RTS,S Regimen C Group | This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG003 | Engerix B Regimen A Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
| OG004 | Engerix B Regimen B Group | Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|