Last updated: 11/03/2018 00:33:10

Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 vaccine

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GSK study ID
104297
See study documents
Clinicaltrials.gov ID
NCT00323622
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose.
Trial description: The RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals’ candidate Plasmodium falciparum (P. falciparum) malaria vaccine is being developed for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite P. falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV).
This phase IIb trial is being carried out following the demonstration of efficacy of the candidate malaria vaccine in children in Mozambique: there, the vaccine demonstrated approximately 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease.
In this study, the children from Mozambique (NCT= NCT00197041) are followed-up to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine for a two year period commencing 21 months after Dose 1.
This protocol posting deals with objectives & outcome measures of the extension phase at year 2. During this extension study, no new subjects will be recruited and no vaccine will be administered.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects with serious adverse events (SAEs)

Timeframe: Throughout the entire study period: from Month 21 to Month 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).

Secondary outcomes:

Anti-circumsporozoite protein (CS) antibody concentrations.

Timeframe: At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).

Anti-hepatitis B (HBs) antibody concentrations.

Timeframe: At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).

Time to first or only clinical episode of symptomatic Plasmodium falciparum malaria infection (PFMI) of Primary Case Definition

Timeframe: From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041

Time to first or only episode of symptomatic Plasmodium falciparum malaria infection (PFMI) of Secondary Case Definition 1

Timeframe: From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041

Time to first or only episode of symptomatic Plasmodium falciparum malaria infection (PFMI) of Secondary Case Definition 2

Timeframe: From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041

Time to first or only episode of symptomatic Plasmodium falciparum malaria infection (PFMI) of Secondary Case Definition 3

Timeframe: From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041

Number of Primary Case Definition clinical episodes of symptomatic Plasmodium falciparum malaria infection (PFMI)

Timeframe: From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041

Number of subjects with anemia.

Timeframe: At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).

Number of subjects prevalent for Plasmodium falciparum (P. falciparum) parasitemia

Timeframe: At Months 33 (M33) and 45 (M45) (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).

Interventions:
  • Biological/vaccine: GSK Biologicals’ candidate Plasmodium falciparum malaria vaccine 257049
  • Biological/vaccine: Engerix™-B
  • Biological/vaccine: Hiberix®
  • Biological/vaccine: Prevnar™
  • Drug: sulfadoxine-pyrimethamine
  • Drug: amodiaquine
    • Enrollment:
    1737
    Primary completion date:
    2007-10-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Alonso PL et al. (2005) Duration of protection with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children: single-blind extended follow-up of a randomised controlled trial. Lancet. 366 (9502): 2012-2018.
    Aponte et al. A 4 years follow-up of the safety, immunogenicity and efficacy of the candidate malaria vaccine RTS,S/AS02A in children vaccinated at aged 1 to 4 years in a malaria-endemic region of Mozambique. Abstract presented at the 56th Annual Meeting ASTMH, Philadelphia, PA, USA, 05-07 November 2007.
    Sacarlal J et al. (2009) Long-Term Safety and Efficacy of the RTS,S/AS02A Malaria Vaccine in Mozambican Children. The Journal of Infectious Diseases. 200 (3): 329-336.
    Medical condition
    Malaria
    Product
    SB257049
    Collaborators
    Not applicable
    Study date(s)
    April 2005 to May 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    33 - 69 months
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Completion of Visit 7, Month 21 of 104297 (NCT= NCT00197041).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Completion of Visit 7, Month 21 of 104297 (NCT= NCT00197041). -Written informed consent obtained from the parent(s) or guardian(s) of the subject Exclusion criteria:
    • Planned use of any investigational or non-registered drug or vaccine during the study period.
    • Simultaneous participation in any other clinical trial

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Maputo, Mozambique
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-10-05
    Actual study completion date
    2007-10-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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