Last updated: 11/07/2018 01:26:11
Safety and immunogenicity study of GSK Biologicals' malaria vaccine 257049, when incorporated into an EPI regimen
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Safety and immunogenicity study of GSK Biologicals’ investigational vaccination regimen 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of subjects with serious adverse events (SAEs).
Timeframe: From Month 0 to Month 8
Secondary outcomes:
Concentrations of antibodies against hepatitis B (Anti-HB antibodies).
Timeframe: At Months 0, 1, 3 and 7.
Concentrations of antibodies against hepatitis B (Anti-HB antibodies).
Timeframe: At Months 0, 3, 7 and 8.
Concentrations of antibodies against hepatitis B (Anti-HB antibodies).
Timeframe: At Months 0, 3, 7 and 8.
Concentrations of anti-diphtheria (Anti-D) and anti-tetanus (Anti-T) antibodies.
Timeframe: At Month 3
Number of subjects with serious adverse events (SAEs).
Timeframe: From Month 8 to Month 19
Concentrations of anti-polyribosyl ribitol phosphate (Anti-PRP) antibodies.
Timeframe: At Month 3
Titers for antibodies against poliomyelitis types 1, 2 and 3 (Anti-Polio 1, 2 and 3 antibodies).
Timeframe: At Month 3
Concentrations of anti-Bordetella pertussis toxin (Anti-BPT) antibodies.
Timeframe: At Month 3
Concentrations of anti-measles antibodies.
Timeframe: At Months 7 and 8.
Titers for anti-yellow fever antibodies.
Timeframe: At Months 7 and 8.
Concentrations of anti-circumsporozoite protein (Anti-CS) antibodies.
Timeframe: At Months 0, 1, 3 and 7.
Concentrations of anti-circumsporozoite protein (Anti-CS) antibodies.
Timeframe: At Months 0, 3, 7 and 8.
Concentrations of anti-circumsporozoite protein (Anti-CS) antibodies.
Timeframe: At Months 0, 3, 7 and 8.
Number of subjects with solicited local symptoms.
Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination with the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines.
Number of subjects with solicited general symptoms.
Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 30-day (Days 0-29) follow-up period after any vaccination
Number of subjects with serious adverse events (SAEs).
Timeframe: From Month 0 to Month 19
Interventions:
Enrollment:
511
Primary completion date:
2008-15-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Agnandji ST et al. (2010) Evaluation of the safety and immunogenicity of the RTS,S/AS01E malaria candidate vaccine when integrated in the expanded program of immunization. J infect Dis. 202(7):1076-1087.
Ajua A et al. (2015) The effect of immunization schedule with the malaria vaccine candidate RTS,S/AS01 on protective efficacy and anti-circumsporozoite protein antibody avidity in African infants. Malar J.14(1):72.
Asante KP et al. (2011) Safety and efficacy of the RTS,S/AS01E candidate malaria vaccine given with expanded-programme-on-immunisation vaccines: 19 month follow-up of a randomised, open-label, phase 2 trial. Lancet Infect Dis. 11(10):741-749.
Medical condition
Malaria
Product
SB257049
Collaborators
Not applicable
Study date(s)
April 2007 to October 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
6 - 10 weeks
Accepts healthy volunteers
Yes
- 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.
- Acute disease at the time of enrolment.
- Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
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
2008-15-09
Actual study completion date
2009-07-10
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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