Last updated: 11/07/2018 06:03:10
Consistency of immunogenicity and non inferiority of GSK Biologicals’ candidate malaria vaccine lots in children
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Consistency of immunogenicity and non inferiority of three production lots of GSK Biologicals’ candidate malaria vaccine in children
Trial description: The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Anti-Circumsporozoite (anti-CS) antibody titers
Timeframe: One month post-dose 3 (Month 3)
Secondary outcomes:
Anti-hepatitis B (anti-HB) antibody concentrations
Timeframe: One month post-dose 3 (Month 3)
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: Over a 7-day (Days 0-6)post-vaccination period after each dose and across doses
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: Over a 7-day (Days 0-6) post-vaccination period after each dose and across doses
Number of subjects with unsolicited adverse events
Timeframe: Within the 30-day (Days 0-29) post-vaccination period
Number of subjects with serious adverse events
Timeframe: Up to 8 months post-dose 1
Interventions:
Enrollment:
327
Primary completion date:
2011-22-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Umeh R et al. (2014) Immunogenicity and safety of the candidate RTS,S/AS01 vaccine in young Nigerian children: A randomized, double-blind, lot-to-lot consistency trial. Vaccine. 32(48):6556-6562.
Vandoolaeghe P et al. (2016) The RTS,S/AS01 malaria vaccine in children 5 to 17 months of age at first vaccination. Expert Rev Vaccines. 15(12):1481-1493.
Medical condition
Malaria
Product
SB257049
Collaborators
The PATH Malaria Vaccine Initiative (MVI)
Study date(s)
May 2011 to May 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
5 - 17 months
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- A male or female child between, and including, 5 and 17 months of age at the time of the first vaccination.
- Same sex twins.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female child between, and including, 5 and 17 months of age at the time of the first vaccination.
- Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the child. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects who have received three documented doses of hepatitis B vaccine.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
Exclusion criteria:
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurological disorders or seizures.
- Moderate or severe malnutrition at screening defined as weight for age Z-score less than 2.
- Acute disease and/or fever at the time of enrolment
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
- Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/administration of a licensed vaccine not foreseen by the study protocol within 7 days of the first dose of study vaccine.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Administration of immunoglobulins and/or any blood products within 1 month preceding the first dose of study vaccine or planned administration during the study period.
- Child in care.
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Same sex twins.
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
2011-22-11
Actual study completion date
2012-04-05
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.
Additional information about the trial
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