Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa.
Africa South of the Sahara
Double-Blind Method
Female
Fever
/ chemically induced
Humans
Immunization Schedule
Incidence
Infant
Malaria Vaccines
/ adverse effects
Malaria, Cerebral
/ mortality
Malaria, Falciparum
/ mortality
Male
Meningitis
/ chemically induced
Plasmodium falciparum
Seizures, Febrile
/ chemically induced
Vaccination
(5–10): Malaria
RTS,S/AS01 vaccine
cerebral malaria
febrile convulsions
meningitis
safety
Journal
Human vaccines & immunotherapeutics
ISSN: 2164-554X
Titre abrégé: Hum Vaccin Immunother
Pays: United States
ID NLM: 101572652
Informations de publication
Date de publication:
2019
2019
Historique:
pubmed:
24
4
2019
medline:
19
2
2020
entrez:
24
4
2019
Statut:
ppublish
Résumé
A phase III, double-blind, randomized, controlled trial (NCT00866619) in sub-Saharan Africa showed RTS,S/AS01 vaccine efficacy against malaria. We now present in-depth safety results from this study. 8922 children (enrolled at 5-17 months) and 6537 infants (enrolled at 6-12 weeks) were 1:1:1-randomized to receive 4 doses of RTS,S/AS01 (R3R) or non-malaria control vaccine (C3C), or 3 RTS,S/AS01 doses plus control (R3C). Aggregate safety data were reviewed by a multi-functional team. Severe malaria with Blantyre Coma Score ≤2 (cerebral malaria [CM]) and gender-specific mortality were assessed
Identifiants
pubmed: 31012786
doi: 10.1080/21645515.2019.1586040
pmc: PMC6816384
doi:
Substances chimiques
Malaria Vaccines
0
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2386-2398Références
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