Guiguemde 1990.
Methods | Randomized controlled trial Generation of allocation sequence: stated to be randomized, but method not clear Allocation concealment: unclear Blinding: double blind Inclusion of all randomized participants: 109/123 (88.6%) infants completed the study Length of follow up: 5 months |
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Participants | Number: 123 infants Inclusion criteria: age 3 to 5 months; weight > 3 kg; good general health; parents' consent Exclusion criteria: fever ≥ 38 °C; positive blood slide for Plasmodium falciparum |
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Interventions | 1. (NANP)3‐tetanus toxoid vaccine: 3 doses (subcutaneous, 100 µg) 2. Tetanus toxoid (TT) and NANP)3‐TT vaccine: 2 doses TT and 1 dose vaccine 3. Tetanus toxoid (TT): 3 doses, 1 month apart (Expanded Programme of Immunization (EPI) schedule) | |
Outcomes | 1. Infection with malaria 2. Cases of malaria (case definition: rectal temperature ≥ 38 °C with P. falciparum density ≥ 10,000/µL and no other aetiology for the fever) 3. Anaemia (packed cell volume) 4. Proportion with seroconversion to NANP at day 75 5. Proportion with "efficacious seroconversion" (4‐fold elevation in titre) at day 75 6. Absence of parasites at end of immunization 7. Adverse events | |
Notes | Location: Vallee du Ko, north of Bobo‐Dioulasso, Burkina Faso; area of permanent malaria transmission with maxima in July and November |