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

See results summary

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Completed

Completed

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

Observational study model:

Not applicable

Primary completion date:

2007-10-05

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

Completion of Visit 7, Month 21 of 104297 (NCT= NCT00197041).
Written informed consent obtained from the parent(s) or guardian(s) of the subject

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

Location

GSK Investigational Site

Maputo, Mozambique

Status

Study Complete

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

Completed

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.

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