Last updated: 11/03/2018 08:34:50
Double-blind study of safety and immunogenicity of two candidate malaria vaccines in Gabonese children
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Bridging Safety & Immunogenicity study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years
Trial description: GSK Biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas. The candidate vaccines are designed to offer protection against malaria disease due to the parasite Plasmodium falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection against infection with hepatitis B virus (HBV). This study will evaluate two candidate vaccines. 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:
Double (Care Provider, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Occurrence of SAEs.
Timeframe: From the time of first vaccination until one month post Dose 3
Antibody titers to the P. falciparum circumsporozoite repeat domain (anti-CS).
Timeframe: One month post Dose 3.
Secondary outcomes:
Occurrence of solicited general and local reactions.
Timeframe: Over a 7-day follow-up period after each vaccination.
Occurrence of unsolicited symptoms.
Timeframe: After each vaccination over a 30-day follow-up
Anti-CS antibody titers.
Timeframe: Prior to vaccination, one month post Dose 2
Anti-Hepatitis B surface agent (anti-HBs) antibody titers.
Timeframe: Prior to vaccination, one month post Dose 2 and one month post Dose 3.
Interventions:
Biological/vaccine: GSK Biologicals’ candidate Plasmodium falciparum malaria vaccine 257049
Enrollment:
180
Observational study model:
Not applicable
Primary completion date:
2006-15-09
Time perspective:
Not applicable
Clinical publications:
Agnandji ST et al. (2011) Induction of Plasmodium falciparum-specific CD4+ T cells and memory B cells in Gabonese children vaccinated with RTS,S/AS01E and RTS,S/AS02D. PLoS One. 6(4):e18559.
Lell B et al. (2009) A randomized trial assessing the safety and immunogenicity of AS01 and AS02 adjuvanted RTS,S malaria vaccine candidates in children in Gabon. PLoS One. 4(10): e7611.
Medical condition
Malaria
Product
SB257049
Collaborators
Not applicable
Study date(s)
April 2006 to August 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 48 months
Accepts healthy volunteers
Yes
- A male or female child between 18 months and 4 years of age (up to but not including 5th birthday) at the time of first vaccination.
- Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
- 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:
- Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits)
A male or female child between 18 months and 4 years of age (up to but not including 5th birthday) at the time of first vaccination.
Exclusion criteria:
- Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
- Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of range.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid.
- 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 within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Previous participation in any other malaria vaccine trial.
- Simultaneous participation in any other clinical trial.
- Same sex twin.
- 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.
Acute disease at the time of enrolment.
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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2006-15-09
Actual study completion date
2007-22-08
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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