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J Pediatr. 2004 Feb;144(2):184-90.

Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants.

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1
University of Pennsylvania School of Medicine, Philadelphia, and Merck & Co, Inc, West Point, Pennsylvania 19486, USA.

Erratum in

  • J Pediatr. 2004 Apr;144(4):558.

Abstract

OBJECTIVES:

To investigate safety, efficacy, and immunogenicity of live quadrivalent rotavirus vaccine (QRV) containing human-bovine (WC3) reassortant rotavirus serotypes G1, G2, G3, and P1a.

STUDY DESIGN:

This was a randomized, double-blinded, placebo-controlled trial. During 1993 to 1994, at 10 US study sites, 439 healthy infants approximately 2 to 6 months of age, were enrolled to receive 3 doses of oral QRV or placebo at approximately 8-week intervals.

RESULTS:

The vaccine was generally well tolerated; no serious vaccine-related adverse experiences were reported. Risk differences and 95% confidence intervals suggested no differences between vaccine and placebo recipients in the incidences of fever, irritability, vomiting, or diarrhea during the 14 days after any dose. QRV was 74.6% efficacious (95% CI: 49.5%, 88.3%) in preventing rotavirus acute gastroenteritis (AGE), regardless of severity and 100% efficacious (95% CI: 43.5%, 100%) in preventing severe rotavirus AGE through one rotavirus season. Serotype G1 was identified in most infants with rotavirus AGE. A >or=3-fold rise in serum neutralizing antibody to G1 was observed in 57% (45/79) of vaccinees. A >or=3-fold rise in serum anti-rotavirus IgA and fecal anti-rotavirus IgA was observed in 88% (162/185) and 65% (104/159) of vaccinees, respectively.

CONCLUSIONS:

QRV was generally well tolerated, immungenic, and highly effective against rotavirus gastroenteritis.

PMID:
14760258
DOI:
10.1016/j.jpeds.2003.10.054
[Indexed for MEDLINE]

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