Rotavirus Immunoglobulin A Responses Stimulated by Each of 3 Doses of a Quadrivalent Human/Bovine Reassortant Rotavirus Vaccine
Why the study?
Does a 3-dose regimen of a quadrivalent rotavirus vaccine increase stool rotavirus IgA responses compared to placebo?
Population
74 subjects (subset of a 439-subject study from 1 of 10 study sites)
Comparison
3 doses of a quadrivalent human/bovine… vs Placebo
Design
RCT
Authors
Discussion
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Member takes
Implication
Supports advancement of the quadrivalent rotavirus vaccine; confirms robust mucosal IgA immunogenicity in this RCT.
Structured PICO
Does a 3-dose regimen of a quadrivalent rotavirus vaccine increase stool rotavirus IgA responses compared to placebo?
P
Population
74 subjects (subset of a 439-subject study from 1 of 10 study sites)
I
Intervention
3 doses of a quadrivalent human/bovine reassortant rotavirus vaccine (precursor to RotaTeq)
C
Comparator
Placebo
O
Outcome
Clinically important (≥3-fold) increase in stool rotavirus immunoglobulin A (IgA)surrogate
A 3-dose regimen of the quadrivalent rotavirus vaccine candidate effectively stimulates stool rotavirus IgA responses.
Cite This Study
Ward et al. (2004) studied this question.