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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00323622

Purpose

This candidate 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 Plasmodium 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.

Condition	Intervention	Phase
Plasmodium Falciparum Malaria	Drug: amodiaquine Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Biological: Engerix B Biological: Hiberix Biological: Prevnar Drug: sulfadoxine-pyrimethamine	Phase II

MedlinePlus related topics: Hepatitis Hepatitis B Malaria

Drug Information available for: Pyrimethamine Sulfadoxine Fansidar Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Malaria Vaccines Amodiaquine Amodiaquine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of serious adverse events (SAEs) [ Time Frame: Over a period 21 to 45 months post Dose 1 of GSK 257049 vaccineor comparator vaccine ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Anti-circumsporozoite protein (CS) antibody titres. [ Time Frame: Month 33 & Month 45 ] [ Designated as safety issue: No ]
Anti-hepatitis B (HBs) antibody titres. [ Time Frame: In groups C and D, Month 33 & Month 45 ] [ Designated as safety issue: No ]
In groups A and B, first clinical episode of symptomatic P. falciparum malaria for Primary Case Definition for malaria episodes detected by passive case detection [ Time Frame: Month 21 to 33/Month 33 to 45/Month 2½ to 33/Month 2½ to 45. ] [ Designated as safety issue: No ]
In groups A and B, first clinical episode of symptomatic P. falciparum malaria for Secondary Case Definitions 1 3 for malaria episodes detected by passive case detection [ Time Frame: Month 21 to 33/Month 33 to 45/Month 2½ to 33/Month 2½ to 45. ] [ Designated as safety issue: No ]
In groups A and B, the total number of clinical episodes of symptomatic P. falciparum malaria (Primary Case Definition for malaria episodes). [ Time Frame: From Month 21 to 33/Month 33 to 45/Month 2½ to 33/Month 2½ to 45 ] [ Designated as safety issue: No ]
In groups A and B, presence of anaemia in children. [ Time Frame: At Month 33 and Month 45 ] [ Designated as safety issue: No ]
In groups A and B, the number of asexual stage falciparum parasites per µL of blood for each subject [ Time Frame: At Month 33 and Month 45 ] [ Designated as safety issue: No ]

Enrollment:	1737
Study Start Date:	April 2005
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: No Intervention Subjects received 3 doses of GSK 257049 in the primary study. No vaccines are administered in this study.	Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 IM injection in the deltoid muscle
Group B: No Intervention In the primary study, subjects received: 3 doses of hepatitis B vaccine to children of 24 months and older. 2 doses of a 7-valent pneumococcal conjugate vaccine at first and third vaccination and 1 dose of Haemophilus influenzae type b vaccine at second vaccination to children less than 24 months. No vaccines are administered in this study.	Biological: Engerix B IM injection in the deltoid muscle Biological: Hiberix IM injection in the deltoid muscle Biological: Prevnar IM injection in the deltoid muscle
Group D: No Intervention In the primary study, subjects received sulfadoxine-pyrimethamine and amodiaquine, then: 3 doses of hepatitis B vaccine to children of 24 months and older. 2 doses of a 7-valent pneumococcal conjugate vaccine at first and third vaccination and 1 dose of Haemophilus influenzae type b vaccine at second vaccination to children less than 24 months. No vaccines are administered in this study.	Drug: amodiaquine 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance Biological: Engerix B IM injection in the deltoid muscle Biological: Hiberix IM injection in the deltoid muscle Biological: Prevnar IM injection in the deltoid muscle Drug: sulfadoxine-pyrimethamine 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance
Group C: No Intervention In the primary study, subjects received 4 weeks prior to onset of surveillance sulfadoxine-pyrimethamine and amodiaquine then 3 doses of GSK 257049. No vaccines are administered in this study.	Drug: amodiaquine 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 IM injection in the deltoid muscle Drug: sulfadoxine-pyrimethamine 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

Eligibility

Ages Eligible for Study:	33 Months to 69 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323622

Locations

Mozambique
GSK Investigational Site
Mozambique, Mozambique

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104297
Study First Received:	September 8, 2005
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00323622
Health Authority:	South Africa: Medicines Control Council; United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid
Pyrimethamine
Protozoan Infections
Amodiaquine

Sulfadoxine-pyrimethamine
Parasitic Diseases
Malaria
Sulfadoxine

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Coccidiosis

Therapeutic Uses
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009