Immunogenicity of a Third Scheduled Dose of Rotarix in Australian Indigenous Infants: A Phase IV, Double-blind, Randomized, Placebo-Controlled Clinical Trial.
J Infect Dis
; 226(9): 1537-1544, 2022 11 01.
Article
en En
| MEDLINE
| ID: mdl-35134951
ABSTRACT
BACKGROUND:
Rotarix (GlaxoSmithKline) oral rotavirus vaccine is licensed as 2 doses in the first 6 months of life. In settings with high child mortality rates, clinical protection conferred by 2 doses of Rotarix is reduced. We assessed vaccine immune response when an additional dose of Rotarix was given to Australian Aboriginal children 6 toâ <12 months old.METHODS:
ORVAC is a 2-stage, double-blind, randomized, placebo-controlled trial. Australian Aboriginal children 6 toâ <12 months old who had received 1 or 2 prior doses of Rotarix rotavirus vaccine were randomized 11 to receive an additional dose of Rotarix or matched placebo. The primary immunological end point was seroresponse defined as an anti-rotavirus immunoglobulin A levelâ ≥20 AU/mL, 28-56 days after the additional dose of Rotarix or placebo.RESULTS:
Between March 2018 and August 2020, a total of 253 infants were enrolled. Of these, 178 infants (70%) had analyzable serological results after follow-up; 89 were randomized to receive Rotarix, and 89 to receive placebo. The proportion with seroresponse was 85% after Rotarix compared with 72% after placebo. There were no occurrences of intussusception or any serious adverse events.CONCLUSIONS:
An additional dose of Rotarix administered to Australian Aboriginal infants 6 toâ <12 months old increased the proportion with a vaccine seroresponse. CLINICAL TRIALS REGISTRATION NCT02941107.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Infecciones por Rotavirus
/
Vacunas contra Rotavirus
Tipo de estudio:
Clinical_trials
Límite:
Child
/
Humans
/
Infant
País como asunto:
Oceania
Idioma:
En
Año:
2022
Tipo del documento:
Article