Immunogenicity and safety of the candidate RTS,S/AS01 vaccine in young Nigerian children: A randomized, double-blind, lot-to-lot consistency trial

Highlights • Commercial-scale RTS,S/AS01 lots induced a consistent anti-CS antibody response. • Anti-CS GMT of pooled commercial-scale lots was non-inferior to pilot-scale lot GMT. • The RTS,S/AS01 lots had similar and acceptable tolerability profiles.

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Bibliographic Details
Published in:Vaccine 2014-11, Vol.32 (48), p.6556-6562
Main Authors: Umeh, Rich, Oguche, Stephen, Oguonu, Tagbo, Pitmang, Simon, Shu, Elvis, Onyia, Jude-Tony, Daniyam, Comfort A, Shwe, David, Ahmad, Abdullahi, Jongert, Erik, Catteau, Grégory, Lievens, Marc, Ofori-Anyinam, Opokua, Leach, Amanda
Format: Article
Language:English
Subjects:
Allergy and Immunology
Antibodies, Protozoan - blood
Antibody Formation
Antigens
Applied microbiology
Biological and medical sciences
Children
Consistency
Double-Blind Method
Drug dosages
FDA approval
Female
Fever
Fundamental and applied biological sciences. Psychology
Human protozoal diseases
Humans
Immunization
Immunogenicity
Infant
Infectious diseases
Malaria
Malaria Vaccines - immunology
Malaria Vaccines - standards
Malaria Vaccines - therapeutic use
Malaria, Falciparum - prevention & control
Male
Manufacturing
Medical sciences
Microbiology
Nigeria
Objectives
Parasitic diseases
Protozoal diseases
Regulatory approval
RTS,S/AS01
Safety
Teaching hospitals
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Vaccines, Synthetic - immunology
Vaccines, Synthetic - standards
Vaccines, Synthetic - therapeutic use
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Description
Summary:Highlights • Commercial-scale RTS,S/AS01 lots induced a consistent anti-CS antibody response. • Anti-CS GMT of pooled commercial-scale lots was non-inferior to pilot-scale lot GMT. • The RTS,S/AS01 lots had similar and acceptable tolerability profiles.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2014.07.067