What question did this study set out to answer?

To evaluate the immunogenicity, reactogenicity, and efficacy of two oral doses of the live, attenuated rotavirus vaccine RIX4414 across three viral concentrations when coadministered with routine childhood vaccines.

August 5, 2005The Journal of Infectious Diseases

Evaluation of RIX4414, A Live, Attenuated Rotavirus Vaccine, in a Randomized, Double‐Blind, Placebo‐Controlled Phase 2 Trial Involving 2464 Singaporean Infants

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Authors

KPKong Boo PhuaBoston Children's Hospital SQSeng Hock QuakNational University of Singapore BLBee Wah LeeNational University of Singapore

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Implication

Randomized double-blind trial demonstrates high immunogenicity and tolerability of oral RIX4414 in healthy infants, indicating compatible coadministration with routine childhood vaccines.

Key Points

To evaluate the immunogenicity, reactogenicity, and efficacy of two oral doses of the live, attenuated rotavirus vaccine RIX4414 across three viral concentrations when coadministered with routine childhood vaccines.
Randomized, double-blind, placebo-controlled phase 2 trial conducted across pediatric hospitals and polyclinics in Singapore involving 2,464 healthy infants aged 11–17 weeks.
Infants received two oral doses spaced one month apart containing RIX4414 at three viral concentrations (10^4.7, 10^5.2, or 10^6.1 focus-forming units) or placebo, administered concomitantly with routine infant immunizations.
Vaccine take occurred in 98%–100% of infants receiving RIX4414, with anti-rotavirus IgA seroconversion rates ranging from 76% (95% CI, 68%–83%) to 91% (95% CI, 85%–95%) depending on viral concentration.
Calculated vaccine efficacy against rotavirus gastroenteritis was 82% (P = .046), although the finding was limited by a low number of observed gastroenteritis episodes during follow-up.
RIX4414 was well tolerated across all concentrations without increases in high fever, severe diarrhea, or vomiting relative to placebo, and no interference with routine infant vaccines was observed.

Cite This Study

Phua et al. (2005) studied this question.

synapsesocial.com/papers/6a738b045946a55bc0fb6add https://doi.org/10.1086/431511

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Implication

Randomized double-blind trial demonstrates high immunogenicity and tolerability of oral RIX4414 in healthy infants, indicating compatible coadministration with routine childhood vaccines.

Evaluation of RIX4414, A Live, Attenuated Rotavirus Vaccine, in a Randomized, Double‐Blind, Placebo‐Controlled Phase 2 Trial Involving 2464 Singaporean Infants

Discussion

Member takes

Implication

Key Points

Cite This Study

Evaluation of RIX4414, A Live, Attenuated Rotavirus Vaccine, in a Randomized, Double‐Blind, Placebo‐Controlled Phase 2 Trial Involving 2464 Singaporean Infants

Discussion

Member takes

Implication

Key Points

Cite This Study

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