Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00436007

Purpose

This study is being done to assess the possibility of the potential integration of malaria vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and immunogenic in infants aged 6 to 10 weeks at first dose, when co-administered with other EPI vaccine antigens. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Plasmodium Falciparum Malaria	Biological: Stamaril™ Biological: Tritanrix HepB™/Hiberix™ Biological: Measles vaccine Biological: Polio Sabin™ Biological: GSK Malaria vaccine 257049	Phase II

MedlinePlus related topics: Fever Malaria Measles Polio and Post-Polio Syndrome

Drug Information available for: Malaria Vaccines Measles Vaccine Yellow Fever Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Immunogenicity Study of GSK Biologicals'Malaria Vaccine 257049, When Incorporated Into an Expanded Program on Immunization (EPI) Regimen That Includes Tritanrix HepB/Hib, OPV, Measles and Yellow Fever Vaccination in Infants

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of SAEs. [ Time Frame: From the time of first vaccination until eight months post first study vaccination. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of unsolicited AEs. [ Time Frame: After study vaccination over a 30-day follow-up period (day of vaccination and 29 subsequent days). ] [ Designated as safety issue: Yes ]
Occurrence of solicited general and local reactions. [ Time Frame: Over a 7-day follow-up period (day of vaccination and 6 subsequent days) after study vaccination. ] [ Designated as safety issue: Yes ]
Anti-hepatitis B surface agent (HBs) antibody titers. [ Time Frame: One month post Dose 3 of DTPwHepB/Hib and OPV. ] [ Designated as safety issue: No ]
Anti-diphtheria antibody titers. [ Time Frame: One month post Dose 3 of DTPwHepB/Hib and OPV. ] [ Designated as safety issue: No ]
Anti-tetanus antibody titers. [ Time Frame: One month post Dose 3 of DTPwHepB/Hib and OPV. ] [ Designated as safety issue: No ]
Anti- polyribosyl-ribitol-phosphate (PRP) antibody titers. [ Time Frame: One month post Dose 3 of DTPwHepB/Hib and OPV. ] [ Designated as safety issue: No ]
Anti-polio type 2 antibody titers. [ Time Frame: One month post Dose 3 of DTPwHepB/Hib and OPV. ] [ Designated as safety issue: No ]
Anti-polio type 3 antibody titers. [ Time Frame: One month post Dose 3 of DTPwHepB/Hib and OPV. ] [ Designated as safety issue: No ]
Anti-measles antibody titers. [ Time Frame: One month post measles and yellow fever vaccination in Group A and Group C. ] [ Designated as safety issue: No ]
Anti-yellow fever antibody titers. [ Time Frame: One month post measles and yellow fever vaccination in Group A and Group C. ] [ Designated as safety issue: No ]
Anti HBs antibody titers and antibody titers to the P. falciparum circumsporozoite repeat domain (anti-CS) in Group A and C. [ Time Frame: Prior to first study vaccination and 3, 7 and 8 months post first study vaccination. ] [ Designated as safety issue: No ]
Anti HBs and anti-CS antibody titers. [ Time Frame: Prior to first study vaccination and 2, 3 and 7 months post first study vaccination in Group B. ] [ Designated as safety issue: No ]
Difference between groups in percent seroprotection to HBs [ Time Frame: One month post last dose. ] [ Designated as safety issue: No ]
Difference between groups in percent seroprotection to diphtheria [ Time Frame: One month post last dose. ] [ Designated as safety issue: No ]
Difference between groups in percent seroprotection to tetanus [ Time Frame: One month post last dose. ] [ Designated as safety issue: No ]
Difference between groups in percent seroprotection to PRP [ Time Frame: One month post last dose. ] [ Designated as safety issue: No ]
Ratio of anti-pertussis GMTs between groups [ Time Frame: One month post last dose. ] [ Designated as safety issue: No ]
Difference between groups in percent seroprotection to polio virus type 1 [ Time Frame: One month post last dose. ] [ Designated as safety issue: No ]
Difference between groups in percent seroprotection to polio virus type 2. [ Time Frame: One month post last dose. ] [ Designated as safety issue: No ]
Difference between groups in percent seroprotection to polio virus type 3. [ Time Frame: One month post last dose. ] [ Designated as safety issue: No ]
Difference between groups in percent seroconversion to measles [ Time Frame: One month post last dose. ] [ Designated as safety issue: No ]
Difference between groups in percent seroconversion to yellow fever [ Time Frame: One month post last dose. ] [ Designated as safety issue: No ]
Anti-pertussis antibody titers. [ Time Frame: One month post Dose 3 of DTPwHepB/Hib and OPV. ] [ Designated as safety issue: No ]
Anti-polio type 1 antibody titers. [ Time Frame: One month post Dose 3 of DTPwHepB/Hib and OPV. ] [ Designated as safety issue: No ]

Estimated Enrollment:	510
Study Start Date:	April 2007
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Active Comparator Control group (EPI vaccination schedule)	Biological: Stamaril™ Single dose intramuscular injection. This vaccine will not be administered to infants from Tanzania as this vaccine is not currently foreseen to be introduced to the EPI vaccination schedule in Tanzania. Biological: Tritanrix HepB™/Hiberix™ 3-dose intramuscular injection. Biological: Measles vaccine A measles vaccine, either licensed by the FDA or by the EMEA and/or prequalified by WHO, will be used to vaccinate the infants. The vaccine that will be used will depend on the supply availability of the vaccine. The measles vaccine will be used according to the manufacturer instructions and the Summary of Product Characteristics. Biological: Polio Sabin™ 3-dose vaccination schedule by oral intake.
Group C: Experimental Same EPI vaccination schedule as in Group A, candidate malaria vaccine alternative vaccination schedule 2 (0, 1, 7 month).	Biological: Stamaril™ Single dose intramuscular injection. This vaccine will not be administered to infants from Tanzania as this vaccine is not currently foreseen to be introduced to the EPI vaccination schedule in Tanzania. Biological: Tritanrix HepB™/Hiberix™ 3-dose intramuscular injection. Biological: Measles vaccine A measles vaccine, either licensed by the FDA or by the EMEA and/or prequalified by WHO, will be used to vaccinate the infants. The vaccine that will be used will depend on the supply availability of the vaccine. The measles vaccine will be used according to the manufacturer instructions and the Summary of Product Characteristics. Biological: Polio Sabin™ 3-dose vaccination schedule by oral intake. Biological: GSK Malaria vaccine 257049 3-dose intramuscular injection.
Group B: Experimental Same EPI vaccination schedule as in Group A, candidate malaria vaccine vaccination schedule 1 (0, 1, 2 month).	Biological: Stamaril™ Single dose intramuscular injection. This vaccine will not be administered to infants from Tanzania as this vaccine is not currently foreseen to be introduced to the EPI vaccination schedule in Tanzania. Biological: Tritanrix HepB™/Hiberix™ 3-dose intramuscular injection. Biological: Measles vaccine A measles vaccine, either licensed by the FDA or by the EMEA and/or prequalified by WHO, will be used to vaccinate the infants. The vaccine that will be used will depend on the supply availability of the vaccine. The measles vaccine will be used according to the manufacturer instructions and the Summary of Product Characteristics. Biological: Polio Sabin™ 3-dose vaccination schedule by oral intake. Biological: GSK Malaria vaccine 257049 3-dose intramuscular injection.

Detailed Description:

Two vaccination schedules will be studied, which constitutes the two alternative three dose regimens for the malaria candidate vaccine 257049 integration into EPI. The co-administered EPI vaccines include GSK Biologicals' Tritanrix™-HepB/Hiberix™, a measles vaccine (depending on the supply availability), Aventis Pasteur's Yellow Fever vaccine Stamaril™ and GSK Biologicals' Oral Polio vaccine Polio Sabin™. Tuberculosis vaccine (Bacillus of Calmette and Guerin, BCG) will be administered according to national medical practice and will not be administered as part of this protocol, but will be documented.

Eligibility

Ages Eligible for Study:	6 Weeks to 10 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female infant between 6 and 10 weeks of age at the time of first vaccination.
Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
Subjects who have received one previous dose of OPV and BCG.
Subjects who are born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

Acute disease at the time of enrolment.
Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
Laboratory screening tests out of range, specifically: ALT and creatinine above acceptable limit; Hemoglobin, Platelet count and Total white cell count below acceptable limit.
Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b or hepatitis B vaccines.
BCG administration within one week of proposed administration of a study vaccine.
OPV administration within four weeks of proposed administration of a study vaccine.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Administration of immunoglobulins, blood transfusions or other blood products since birth to the first dose of study vaccine or planned administration during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Simultaneous participation in any other clinical trial.
Twins (to avoid misidentification).
Maternal death.
History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436007

Locations

Gabon
GSK Investigational Site
Lambaréné, Gabon
Ghana
GSK Investigational Site
Kintampo, Ghana
Tanzania
GSK Investigational Site
Dar-es-Salaam, Tanzania

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106369
Study First Received:	February 15, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00436007
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Malaria
Plasmodium falciparum
Africa

Study placed in the following topic categories:

Fever
Protozoan Infections
Yellow Fever
Measles

Yellow fever
Parasitic Diseases
Malaria

Additional relevant MeSH terms:

Coccidiosis

ClinicalTrials.gov processed this record on January 16, 2009