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

NCT ID: NCT00323622

Last Updated: 2016-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1737 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cohort 1-RTS,S/AS02A <24M Group

Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.

Group Type EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Intervention Type BIOLOGICAL

IM injection in the deltoid muscle

Cohort 1-RTS,S/AS02A ≥24M Group

Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.

Group Type EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Intervention Type BIOLOGICAL

IM injection in the deltoid muscle

Cohort 2-RTS,S/AS02A <24M Group

Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.

Group Type EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Intervention Type BIOLOGICAL

IM injection in the deltoid muscle

sulfadoxine-pyrimethamine

Intervention Type DRUG

1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

amodiaquine

Intervention Type DRUG

1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

Cohort 2-RTS,S/AS02A ≥24M Group

Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.

Group Type EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Intervention Type BIOLOGICAL

IM injection in the deltoid muscle

sulfadoxine-pyrimethamine

Intervention Type DRUG

1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

amodiaquine

Intervention Type DRUG

1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

Cohort 1-Prevnar-Hiberix <24M Group

Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.

Group Type ACTIVE_COMPARATOR

Hiberix®

Intervention Type BIOLOGICAL

IM injection in the deltoid muscle

Prevnar™

Intervention Type BIOLOGICAL

IM injection in the deltoid muscle

Cohort 1-Engerix-B ≥24M Group

Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.

Group Type ACTIVE_COMPARATOR

Engerix™-B

Intervention Type BIOLOGICAL

IM injection in the deltoid muscle

Cohort 2-Prevnar- Hiberix <24M Group

Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.

Group Type ACTIVE_COMPARATOR

Hiberix®

Intervention Type BIOLOGICAL

IM injection in the deltoid muscle

Prevnar™

Intervention Type BIOLOGICAL

IM injection in the deltoid muscle

sulfadoxine-pyrimethamine

Intervention Type DRUG

1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

amodiaquine

Intervention Type DRUG

1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

Cohort 2-Engerix-B ≥24M Group

Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.

Group Type ACTIVE_COMPARATOR

Engerix™-B

Intervention Type BIOLOGICAL

IM injection in the deltoid muscle

sulfadoxine-pyrimethamine

Intervention Type DRUG

1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

amodiaquine

Intervention Type DRUG

1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

Interventions

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GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

IM injection in the deltoid muscle

Intervention Type BIOLOGICAL

Engerix™-B

IM injection in the deltoid muscle

Intervention Type BIOLOGICAL

Hiberix®

IM injection in the deltoid muscle

Intervention Type BIOLOGICAL

Prevnar™

IM injection in the deltoid muscle

Intervention Type BIOLOGICAL

sulfadoxine-pyrimethamine

1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

Intervention Type DRUG

amodiaquine

1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

Intervention Type DRUG

Other Intervention Names

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RTS S/AS02A vaccine

Eligibility Criteria

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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
Minimum Eligible Age

33 Months

Maximum Eligible Age

69 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Maputo, , Mozambique

Site Status

Countries

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Mozambique

References

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Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, Aide P, Sigauque B, Milman J, Mandomando I, Bassat Q, Guinovart C, Espasa M, Corachan S, Lievens M, Navia MM, Dubois MC, Menendez C, Dubovsky F, Cohen J, Thompson R, Ballou WR. 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. 2005 Dec 10;366(9502):2012-8. doi: 10.1016/S0140-6736(05)67669-6.

Reference Type BACKGROUND
PMID: 16338450 (View on PubMed)

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.

Reference Type BACKGROUND

Sacarlal J, Aide P, Aponte JJ, Renom M, Leach A, Mandomando I, Lievens M, Bassat Q, Lafuente S, Macete E, Vekemans J, Guinovart C, Sigauque B, Sillman M, Milman J, Dubois MC, Demoitie MA, Thonnard J, Menendez C, Ballou WR, Cohen J, Alonso PL. Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children. J Infect Dis. 2009 Aug 1;200(3):329-36. doi: 10.1086/600119.

Reference Type BACKGROUND
PMID: 19569964 (View on PubMed)

Aide P, Dobano C, Sacarlal J, Aponte JJ, Mandomando I, Guinovart C, Bassat Q, Renom M, Puyol L, Macete E, Herreros E, Leach A, Dubois MC, Demoitie MA, Lievens M, Vekemans J, Loucq C, Ballou WR, Cohen J, Alonso PL. Four year immunogenicity of the RTS,S/AS02(A) malaria vaccine in Mozambican children during a phase IIb trial. Vaccine. 2011 Aug 11;29(35):6059-67. doi: 10.1016/j.vaccine.2011.03.041. Epub 2011 Apr 7.

Reference Type DERIVED
PMID: 21443960 (View on PubMed)

Study Documents

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Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Clinical Study Report

View Document

Document Type: Study Protocol

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Dataset Specification

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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104297

Identifier Type: -

Identifier Source: org_study_id