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Malaria vaccine was safe for infants and did not interfere with the immunogenicity of coadministered antigens

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STUDY DESIGN

Design:

randomised controlled trial. ClinicalTrials.gov NCT00289185.

Allocation:

concealed.*

Blinding:

blinded (parents, healthcare providers, investigators, data collectors, outcome assessors, and data analysts).*

STUDY QUESTION

Setting:

hospital in Bagamoyo, Tanzania.

Patients:

340 infants 6–10 weeks of age (mean age 8 wks, 52% girls) who had been born at 36–42 weeks of gestation weighing ⩾2500 g. Infants were excluded if they were born to mothers positive for HIV or hepatitis B virus, had congenital malformations, or were same-sex twins.

Intervention:

3 doses of the RTS,S/AS02D malaria and hepatitis B vaccine (n = 170) or a hepatitis B vaccine only (n = 170) at 8, 12, and 16 weeks of age. All infants also received vaccines against diphtheria, tetanus, pertussis, and Haemophilus influenzae type B, normally provided by the World Health Organization’s Expanded Program on Immunization (EPI). …

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