Status:
COMPLETED
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria
Malaria Vaccines
Eligibility:
All Genders
6-10 years
Phase:
PHASE2
Brief Summary
GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a candidate malaria vaccine GSK 257049 for the routine immunization of infants and children living in malaria e...
Detailed Description
This is a phase 2b trial designed to evaluate the safety and immunogenicity of RTS,S/AS02D when co-administered with a multivalent DTPw/Hib (Aventis Pasteur's TETRActHib vaccine). Infants randomized t...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- A male or female infant between 6 and 10 weeks of age 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.
- 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).
- Born to a mother who is HBsAg negative \& HIV negative.
- Born after a normal gestation period (between 36 and 42 weeks).
- Subjects who live within a 5 km radius of a dispensary.
- 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 for haemoglobin, total white cell count, platelets, ALT and creatinine.
- 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.
- 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 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.
- 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.
Exclusion
Key Trial Info
Start Date :
September 27 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2009
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00289185
Start Date
September 27 2006
End Date
January 15 2009
Last Update
October 29 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Dar es Salaam, Tanzania