Status:
COMPLETED
Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
GSK Biologicals is developing in partnership with the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative a candidate malaria vaccine for the routine immunization of infants...
Detailed Description
All infants participating in this phase I/IIb study will receive TETRActHib (a licensed diphtheria-tetanus-pertussis Haemophilus influenzae vaccine manufactured by Aventis Pasteur) by IM injection in ...
Eligibility Criteria
Inclusion
- A male or female infant of between 6 and 12 weeks of age at the time of first vaccination.
- Written informed consent obtained from the parent(s) or guardian(s) of the subject
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born to a mother who is hepatitis B surface antigen (HBsAg) negative and human immunodeficiency virus (HIV) negative.
- Born after a normal gestation period (between 36 and 42 weeks).
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion
- Bacillus Calmette-Guérin tuberculosis vaccine (BCG) administration within one week of proposed administration of a study vaccine.
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth
- Any chronic drug therapy to be continued during the study period.
- Previous vaccination with diphtheria, tetanus, pertussis, Haemophilus influenzae type b or hepatitis B vaccines.
- Major congenital abnormality.
- Serious acute or chronic illness determined by clinical, physical examination and laboratory screening tests
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of any neurological disorders or seizures.
- Maternal death.
- Hemoglobin \< 80 g/L
- Simultaneous participation in any other clinical trial.
- Same sex twin
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trialModerate malnutrition at screening
Key Trial Info
Start Date :
August 23 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2007
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00197028
Start Date
August 23 2005
End Date
December 27 2007
Last Update
August 20 2018
Active Locations (1)
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1
GSK Investigational Site
Maputo, Mozambique