Completed

Study Description:

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.

GSK Study ID:

113681


ClinicalTrials.gov Identifier:

NCT01345240


Has Results Available Below
EudraCT Number:

2011-001508-37


Study Overview

Medical Conditions

Parasite Infections

Product

GSK1024850A;GSK1059752A;SB208108;SB208355;SB257049;SB444563;SKF103860

Collaborators

N/A


Date

November 2011 to February 2017

Type

Interventional

Phase

3


Gender

All

Age

8 weeks - 12 weeks

Accepts Healthy Volunteers

Yes


Study Documents

This study has Protocol and Result summary on ClinicalTrial.gov. Click here to learn more.

Locations

Burkina Faso, Ouagadougou 01 Completed
Ghana, Kumasi Completed

Study Design

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Percentage of seroprotected subjects against Anti-Hepatitis B (HBs) antigen
    Timeframe: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B

  • Anti-Hepatitis B (HBs) antibody concentrations
    Timeframe: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™

  • Anti-Hepatitis B (HBs) antibody concentrations.
    Timeframe: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™

  • Anti-Hepatitis B (HBs) antibody concentrations
    Timeframe: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B

  • Anti-Hepatitis B (HBs) antibody concentrations.
    Timeframe: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B

Secondary Outcomes:

  • Anti-Hepatitis B (HBs) antibody concentrations
    Timeframe: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™

  • Anti-Hepatitis B (HBs) antibody concentrations.
    Timeframe: 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.
    Timeframe: 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).
    Timeframe: 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).
    Timeframe: At Month 51, aka one month post the Month 50 booster dose of Engerix-B™

  • Anti-circumsporozoite protein (anti-CS) antibody concentrations
    Timeframe: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™

  • Anti-circumsporozoite protein (anti-CS) antibody concentrations .
    Timeframe: At Month 14, aka at 12 months post Dose 3 of RTS,S vaccine or Engerix-B™.

  • Anti-circumsporozoite protein (anti-CS) antibody concentrations .
    Timeframe: At Month 14, aka at 12 months post Dose 3 of RTS,S vaccine or Engerix-B

  • Pneumococcal antibody concentrations against Synflorix pneumococcal vaccine serotypes.
    Timeframe: At Month 3, aka at one month post Dose 3 of Synflorix

  • Pneumococcal antibody concentrations against Synflorix pneumococcal vaccine serotypes.
    Timeframe: At Month 17, aka one month post the Month 16 booster dose of Synflorix

  • Titers for opsonophagocytic activity against Synflorix pneumococcal vaccine serotypes.
    Timeframe: At Month 3, aka at one month (1M) post Dose 3 of Synflorix

  • Titers for opsonophagocytic activity against Synflorix pneumococcal vaccine serotypes.
    Timeframe: At Month 17, aka one month post the Month 16 booster dose of Synflorix

  • Anti-protein D (PD) antibody concentrations
    Timeframe: At Month 3, aka at one month post Dose 3 of Synflorix™

  • Anti-protein D (PD) antibody concentrations
    Timeframe: At Month 17, aka one month post the Month 16 booster dose of Synflorix™

  • Concentrations of antibodies against acellular B-pertussis (BPT)
    Timeframe: At Day 0 and at Month 3 (one month post Dose 3 of Infanrix™-Hib)

  • Anti-Rotavirus (anti-RV) antibody concentrations
    Timeframe: At Month 3, aka one month post Dose 2 of Rotarix™

  • Number of subjects with solicited local symptoms
    Timeframe: 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
    Timeframe: 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)
    Timeframe: From Day 0 to Month 8.

  • Number of subjects with potential immune mediated disorders (pIMDs)
    Timeframe: From Day 0 to Month 26

  • Number of subjects with potential immune mediated disorders (pIMDs)
    Timeframe: Up to Study End at Month 51

  • Number of subjects with unsolicited adverse events (AEs)
    Timeframe: 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)
    Timeframe: 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)
    Timeframe: From Day 0 to Month 8

  • Number of subjects with any and fatal serious adverse events (SAEs)
    Timeframe: From Day 0 to Month 26

  • Number of subjects with any, fatal and related serious adverse events (SAEs)
    Timeframe: From Day 0 up to Study End (Month 51)

  • Pneumococcal antibody concentrations against Synflorix™ pneumococcal vaccine serotypes.
    Timeframe: At Month 3, aka at one month post Dose 3 of Synflorix™

  • Pneumococcal antibody concentrations against Synflorix™ pneumococcal vaccine serotypes.
    Timeframe: At Month 17, aka one month post the Month 16 booster dose of Synflorix™

  • Titers for opsonophagocytic activity against Synflorix™ pneumococcal vaccine serotypes.
    Timeframe: At Month 3, aka at one month (1M) post Dose 3 of Synflorix™

  • Titers for opsonophagocytic activity against Synflorix™ pneumococcal vaccine serotypes.
    Timeframe: At Month 17, aka one month post the Month 16 booster dose of Synflorix™

  • Number of subjects with any and fatal serious adverse events (SAEs)
    Timeframe: Up to Study End at Month 51

  • Anti-Hepatitis B (HBs) antibody concentrations
    Timeframe: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B

  • Anti-Hepatitis B (HBs) antibody concentrations.
    Timeframe: 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.
    Timeframe: 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).
    Timeframe: 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).
    Timeframe: At Month 51, aka one month post the Month 50 booster dose of Engerix-B

  • Anti-circumsporozoite protein (anti-CS) antibody concentrations
    Timeframe: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B

  • Anti-circumsporozoite protein (anti-CS) antibody concentrations .
    Timeframe: At Months 38 and 50, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B

  • Anti-protein D (PD) antibody concentrations
    Timeframe: At Month 3, aka at one month post Dose 3 of Synflorix

  • Anti-protein D (PD) antibody concentrations
    Timeframe: At Month 17, aka one month post the Month 16 booster dose of Synflorix

  • Concentrations of antibodies against acellular B-pertussis (BPT)
    Timeframe: At Day 0 and at Month 3 (one month post Dose 3 of Infanrix-Hib)

  • Anti-Rotavirus (anti-RV) antibody concentrations
    Timeframe: At Month 3, aka one month post Dose 2 of Rotarix

  • Number of subjects with solicited local symptoms
    Timeframe: 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
    Timeframe: 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)
    Timeframe: From Day 0 up to Study End (Month 51)

  • Number of subjects with unsolicited adverse events (AEs)
    Timeframe: 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)
    Timeframe: Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B

Arms:
  • 11

Interventions:

  • Biological/Vaccine: GlaxoSmithKline (GSK) Biologicals’ candidate Plasmodium falciparum malaria vaccine 257049
  • Biological/Vaccine: Engerix-B™ vaccine
  • Biological/Vaccine: Infanrix/Hib™ vaccine
  • Biological/Vaccine: Polio Sabin™ vaccine
  • Biological/Vaccine: Rotarix™ vaccine
  • Biological/Vaccine: Synflorix™ vaccine
  • Biological/Vaccine: Measles vaccine
  • Biological/Vaccine: Yellow fever vaccine

Keyword:

  • Africa, Plasmodium falciparum, Malaria vaccine, hepatitis B, EPI
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 705