Study of safety, immunogenicity and efficacy of a candidate malaria vaccine in Tanzanian infants.

• Conditions: Healthy volunteers (Primary immunization against Plasmodium falciparum malaria).; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2015-001539-19-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-13
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 340

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 par-ents/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.
•Born to a mother who is HIV negative.
•Born after a normal gestation period (between 36 and 42 weeks).
•Subjects who live within a 5 km radius of a dispensary.
Are the trial subjects under 18? yes
Number of subjects for this age range: 340
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Acute disease at the time of enrollment.
•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, alanine aminotransferase and creatinine.
•Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Haemophilus 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 (defined as more than 14 days) 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified