What question did this study set out to answer?

To evaluate the safety, particularly regarding intussusception risk, and efficacy of a live oral pentavalent human-bovine reassortant rotavirus vaccine in healthy infants.

January 4, 2006New England Journal of MedicineOpen Access

Safety and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus Vaccine

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Authors

TVTimo VesikariMerck & Co., Inc., Rahway, NJ, USA (United States)DMDavid O. MatsonCincinnati Children's Hospital Medical Center PDPenelope H. DennehyBrown University

Discussion

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Implication

Randomized double-blind trial demonstrates pentavalent rotavirus vaccine prevents severe gastroenteritis without increasing intussusception in infants, highlighting its strong clinical protection.

Key Points

To evaluate the safety, particularly regarding intussusception risk, and efficacy of a live oral pentavalent human-bovine reassortant rotavirus vaccine in healthy infants.
Randomized, double-blind, placebo-controlled trial evaluating healthy infants 6 to 12 weeks of age who received three oral doses of pentavalent rotavirus vaccine (N=34,035) or placebo (N=34,003) at 4-to-10-week intervals (ClinicalTrials.gov: NCT00090233).
Active surveillance monitored serious adverse events, specifically intussusception within 42 days of any dose and up to one year after dose one, as well as rotavirus gastroenteritis encounters.
Intussusception within 42 days of any dose occurred in 6 vaccine recipients and 5 placebo recipients (relative risk, 1.6; 95% CI, 0.4 to 6.4), and in 12 vaccine vs. 15 placebo recipients within one year.
The vaccine reduced hospitalizations and emergency department visits for G1–G4 rotavirus gastroenteritis occurring ≥14 days post-third dose by 94.5% (95% CI, 91.2 to 96.6%) and reduced clinic visits by 86.0% (95% CI, 73.9 to 92.5%).
In a nested substudy, efficacy through the first full rotavirus season was 74.0% (95% CI, 66.8 to 79.9%) against any G1–G4 gastroenteritis and 98.0% (95% CI, 88.3 to 100%) against severe gastroenteritis.

Cite This Study

Vesikari et al. (2006) studied this question.

synapsesocial.com/papers/6a144ea740803be22f895562 https://doi.org/10.1056/nejmoa052664

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Implication

Randomized double-blind trial demonstrates pentavalent rotavirus vaccine prevents severe gastroenteritis without increasing intussusception in infants, highlighting its strong clinical protection.

Safety and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus Vaccine

Discussion

Member takes

Implication

Key Points

Cite This Study

Safety and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus Vaccine

Discussion

Member takes

Implication

Key Points

Cite This Study

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