Status:
COMPLETED
Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
The PATH Malaria Vaccine Initiative (MVI)
Conditions:
Malaria
Eligibility:
All Genders
1-7 years
Phase:
PHASE2
Brief Summary
The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EP...
Eligibility Criteria
Inclusion
- All subjects must satisfy the following criteria at study entry:
- A male or female infant between 1 and 7 days (inclusive) of age (where day 1 is day of birth).
- 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 the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
- Born to a mother negative for HIV antibody and Hepatitis B surface antigen.
- Subjects who are born after a normal gestation period (between 37 and 42 weeks) (Gestational age will be determined by carrying out a clinical assessment on infants according to the principles set out by Dubowitz (1970) in the first 5 days of life).
- A minimum weight of 2.5 kg.
Exclusion
- The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- Acute or chronic illness determined by clinical or physical examination and laboratory screening tests including, but not limited to:
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects.
- History of any neurological disorders or seizures.
- Laboratory screening tests out of normal ranges/limits defined per protocol.
- Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b, hepatitis B, BCG tuberculosis, measles or oral polio vaccines.
- Planned administration/administration of a licensed vaccine (i.e. a vaccine that is approved by one of the following authorities: FDA or EU member state or WHO \[with respect to prequalification\]) not foreseen by the study protocol within 7 days of the first dose of study vaccine.
- 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.
- Use of a drug or vaccine that is not approved for that indication (by one of the following authorities: FDA or EU member state or WHO \[with respect to prequalification\]) other than the study vaccine starting at birth or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Simultaneous participation in any other clinical trial.
- Same-sex 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.
- Children will not be enrolled if any maternal, obstetrical or neonatal event that has occurred might, in the judgment of the investigator, result in increased neonatal/infant morbidity
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Key Trial Info
Start Date :
January 13 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2014
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT01231503
Start Date
January 13 2011
End Date
December 23 2014
Last Update
August 15 2018
Active Locations (1)
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1
GSK Investigational Site
Bangwe, Blantyre, Malawi, 3