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Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants.
J Pediatr. 2004 Feb; 144(2):184-90.JPed

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.

Authors+Show Affiliations

University of Pennsylvania School of Medicine, Philadelphia, and Merck & Co, Inc, West Point, Pennsylvania 19486, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14760258

Citation

Clark, H Fred, et al. "Safety, Efficacy, and Immunogenicity of a Live, Quadrivalent Human-bovine Reassortant Rotavirus Vaccine in Healthy Infants." The Journal of Pediatrics, vol. 144, no. 2, 2004, pp. 184-90.
Clark HF, Bernstein DI, Dennehy PH, et al. Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants. J Pediatr. 2004;144(2):184-90.
Clark, H. F., Bernstein, D. I., Dennehy, P. H., Offit, P., Pichichero, M., Treanor, J., Ward, R. L., Krah, D. L., Shaw, A., Dallas, M. J., Laura, D., Eiden, J. J., Ivanoff, N., Kaplan, K. M., & Heaton, P. (2004). Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants. The Journal of Pediatrics, 144(2), 184-90.
Clark HF, et al. Safety, Efficacy, and Immunogenicity of a Live, Quadrivalent Human-bovine Reassortant Rotavirus Vaccine in Healthy Infants. J Pediatr. 2004;144(2):184-90. PubMed PMID: 14760258.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants. AU - Clark,H Fred, AU - Bernstein,David I, AU - Dennehy,Penelope H, AU - Offit,Paul, AU - Pichichero,Michael, AU - Treanor,John, AU - Ward,Richard L, AU - Krah,David L, AU - Shaw,Alan, AU - Dallas,Michael J, AU - Laura,Digilio, AU - Eiden,Joseph J, AU - Ivanoff,Nathalie, AU - Kaplan,Karen M, AU - Heaton,Penny, PY - 2004/2/5/pubmed PY - 2004/3/18/medline PY - 2004/2/5/entrez SP - 184 EP - 90 JF - The Journal of pediatrics JO - J. Pediatr. VL - 144 IS - 2 N2 - 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. SN - 0022-3476 UR - https://www.unboundmedicine.com/medline/citation/14760258/Safety_efficacy_and_immunogenicity_of_a_live_quadrivalent_human_bovine_reassortant_rotavirus_vaccine_in_healthy_infants_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3476(03)00774-1 DB - PRIME DP - Unbound Medicine ER -