Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01345240
First received: April 28, 2011
Last updated: August 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Malaria
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Engerix-B™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Synflorix™ vaccine
Biological: Measles vaccine
Biological: Yellow fever vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-Hepatitis B (HBs) Antibody Concentrations [ Time Frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™ ] [ Designated as safety issue: No ]
    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™).

  • Anti-Hepatitis B (HBs) Antibody Concentrations. [ Time Frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™ ] [ Designated as safety issue: No ]
    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 RTS,S or Engerix-B™ vaccination regimen received.


Secondary Outcome Measures:
  • Anti-Hepatitis B (HBs) Antibody Concentrations [ Time Frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™ ] [ Designated as safety issue: No ]
    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.

  • Anti-Hepatitis B (HBs) Antibody Concentrations. [ Time Frame: At Month 51, aka one month post the Month 50 booster dose of Engerix-B™ ] [ Designated as safety issue: No ]
    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. Results will be posted when they become available.

  • Anti-Hepatitis B (HBs) Antibody Concentrations. [ Time Frame: At Months 14, 26, 38 and 50, aka at 12, 24, 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B™ ] [ Designated as safety issue: No ]
    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. Results will be posted when they become available.

  • Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1). [ Time Frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™ ] [ Designated as safety issue: No ]
    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.

  • Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1). [ Time Frame: At Month 51, aka one month post the Month 50 booster dose of Engerix-B™ ] [ Designated as safety issue: No ]
    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. Results will be posted when they become available.

  • Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations [ Time Frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™ ] [ Designated as safety issue: No ]
    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 with study groups pooled by vaccination regimen received.

  • Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations . [ Time Frame: At Months 14, 26, 38 and 50, aka at 12, 24, 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B™ ] [ Designated as safety issue: No ]
    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. Results will be posted when they become available.

  • Pneumococcal Antibody Concentrations Against Synflorix™ Pneumococcal Vaccine Serotypes. [ Time Frame: At Month 3, aka at one month post Dose 3 of Synflorix™ ] [ Designated as safety issue: No ]
    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 a cut-off value of 0.35μg/mL by enzyme-linked immunosorbent assay (ELISA). 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.

  • Pneumococcal Antibody Concentrations Against Synflorix™ Pneumococcal Vaccine Serotypes. [ Time Frame: At Month 17, aka one month post the Month 16 booster dose of Synflorix™ ] [ Designated as safety issue: No ]
    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 a cut-off value of 0.35μg/mL by enzyme-linked immunosorbent assay (ELISA). Results will be posted when they become available.

  • Titers for Opsonophagocytic Activity Against Synflorix™ Pneumococcal Vaccine Serotypes. [ Time Frame: At Month 3, aka at one month (1M) post Dose 3 of Synflorix™ ] [ Designated as safety issue: No ]

    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.


  • Titers for Opsonophagocytic Activity Against Synflorix™ Pneumococcal Vaccine Serotypes. [ Time Frame: At Month 17, aka one month post the Month 16 booster dose of Synflorix™ ] [ Designated as safety issue: No ]
    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. Results will be posted when they become available.

  • Anti-protein D (PD) Antibody Concentrations [ Time Frame: At Month 3, aka at one month post Dose 3 of Synflorix™ ] [ Designated as safety issue: No ]
    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.

  • Anti-protein D (PD) Antibody Concentrations [ Time Frame: At Month 17, aka one month post the Month 16 booster dose of Synflorix™ ] [ Designated as safety issue: No ]
    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. . Results will be posted when they become available.

  • Concentrations of Antibodies Against Acellular B-pertussis (BPT) [ Time Frame: At Day 0 and at one month post Dose 3 of Infanrix™-Hib ] [ Designated as safety issue: No ]
    The antibodies against BPTassessed 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.

  • Anti-Rotavirus (Anti-RV) Antibody Concentrations [ Time Frame: At Month 3, aka one month post Dose 2 of Rotarix™ ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Solicited Local Symptoms [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Solicited General Symptoms [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Potential Immune Mediated Disorders (pIMDs) [ Time Frame: From Day 0 to Month 8. ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Potential Immune Mediated Disorders (pIMDs) [ Time Frame: From study start at Day 0 to study end at Month 51 ] [ Designated as safety issue: No ]
    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. Results will be posted when they become available.

  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B™ ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) [ Time Frame: Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B™ ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) [ Time Frame: From Day 0 to Month 8 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) [ Time Frame: From Day 0 to Study End at Month 51 ] [ Designated as safety issue: No ]
    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. Results will be posted when they become available.


Enrollment: 705
Study Start Date: November 2011
Estimated Study Completion Date: December 2016
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RTS,S Regimen A Lot 1 Group
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 Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ 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 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.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
Biological: Engerix-B™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Biological: Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Biological: Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Biological: Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Biological: Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Biological: Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Biological: Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Experimental: RTS,S Regimen A Lot 2 Group
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 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.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
Biological: Engerix-B™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Biological: Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Biological: Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Biological: Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Biological: Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Biological: Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Biological: Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Experimental: RTS,S Regimen A Lot 3 Group
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 Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ 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 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.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
Biological: Engerix-B™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Biological: Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Biological: Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Biological: Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Biological: Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Biological: Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Biological: Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Experimental: RTS,S Regimen B Lot 1 Group
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 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. 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. 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.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
Biological: Engerix-B™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Biological: Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Biological: Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Biological: Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Biological: Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Biological: Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Biological: Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Experimental: RTS,S Regimen B Lot 2 Group
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 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. 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. 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.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
Biological: Engerix-B™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Biological: Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Biological: Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Biological: Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Biological: Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Biological: Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Biological: Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Experimental: RTS,S Regimen B Lot 3 Group
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 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. 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. 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.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
Biological: Engerix-B™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Biological: Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Biological: Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Biological: Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Biological: Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Biological: Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Biological: Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Experimental: RTS,S Regimen C Lot 1 Group
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 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. 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. 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.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
Biological: Engerix-B™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Biological: Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Biological: Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Biological: Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Biological: Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Biological: Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Biological: Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Experimental: RTS,S Regimen C Lot 2 Group
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 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. 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. 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.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
Biological: Engerix-B™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Biological: Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Biological: Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Biological: Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Biological: Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Biological: Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Biological: Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Experimental: RTS,S Regimen C Lot 3 Group
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 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. 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. 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.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
Biological: Engerix-B™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Biological: Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Biological: Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Biological: Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Biological: Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Biological: Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Biological: Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Active Comparator: 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.
Biological: Engerix-B™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Biological: Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Biological: Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Biological: Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Biological: Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Biological: Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Biological: Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Active Comparator: 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.
Biological: Engerix-B™ vaccine
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Biological: Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Biological: Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Biological: Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Biological: Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Biological: Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Biological: Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.

  Eligibility

Ages Eligible for Study:   8 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

  • A male or female infant aged between 8 and 12 weeks inclusive at the time of first vaccination
  • Signed or thumb-printed informed consent obtained from the parent(s)/Legally Acceptable Representative [LAR(s)] of the child. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an independent witness
  • Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol
  • Healthy subjects as established by medical history and clinical examination before entering into the study
  • Born to a mother who is Hepatitis B surface antigen (HBsAg) negative
  • Born to a mother who is Human Immunodeficiency Virus (HIV) negative
  • Born after a normal gestation period of 36 to 42 weeks inclusive.

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:

  • Child in care
  • Acute disease and/or fever at the time of enrolment
  • Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests
  • Laboratory screening tests out of range
  • Previous vaccination with diphtheria, tetanus, pertussis, Haemophilus influenzae type b, Streptococcus pneumoniae, hepatitis B vaccine or rotavirus vaccines.
  • Planned administration/administration of a licensed vaccine not foreseen by the study protocol within 7 days of the first dose of study vaccine.
  • Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Administration of immunoglobulins and/or any blood products in the period between birth and Dose 1 and within the three months preceding planned vaccine administration during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs in the period between birth and Dose 1.
  • Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Same sex twin
  • Maternal death
  • History of allergic reactions or anaphylaxis to previous immunizations.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
  • Any other findings that the investigator feels would result in data collected being incomplete or of poor quality.
  • Previous participation in any other malaria vaccine trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345240

Locations
Burkina Faso
GSK Investigational Site
Ouagadougou 01, Burkina Faso
Ghana
GSK Investigational Site
Kumasi, Ghana
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01345240     History of Changes
Other Study ID Numbers: 113681
Study First Received: April 28, 2011
Results First Received: December 19, 2013
Last Updated: August 4, 2014
Health Authority: Ghana: Food and Drugs Board (FDB)
Burkina Faso: Ministère de la Santé du Burkina Faso

Keywords provided by GlaxoSmithKline:
Africa
Plasmodium falciparum
Malaria vaccine
hepatitis B
EPI

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Malaria
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 18, 2014