Rotavirus Efficacy and Safety Trial (REST)

This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis...

Date First Received: August 25, 2004

Last Updated: May 28, 2009

Verified by: Merck, May 2009

Clinical Trial Phase: Phase 3 | Start Date: January 2001

Overall Status: Completed

Estimated Enrollment: 60000

Brief Summary

Official Title: “Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants”

Condition Keyword(s):

This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2004

Intervention(s) in this Clinical Trial

  • Biological: Rotateq
    • 3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
  • Biological: Comparator: Placebo
    • 3 doses of 2.0 mL Placebo to RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • RotaTeq
  • Placebo Comparator: 2
    • Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Occurrence of clinical rotavirus disease caused by the composite of the rotavirus serotypes contained within the vaccine more than 14 days following the third dose
    • Time Frame: At least 14 days following the third vaccination
      Safety Issue?: No

Secondary Measures

  • Serum neutralizing antibody (SNA) responses against rotavirus
    • Time Frame: 14 days following the 3rd vaccination
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

  • Inclusion Criteria: - Healthy infants Exclusion Criteria: - None Specified

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Weeks

Maximum Age for this Clinical Trial: 12 Weeks

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Sponsor Information

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Related Publications

Citations Reporting Results

Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, Dallas MJ, Heyse JF, Goveia MG, Black SB, Shinefield HR, Christie CD, Ylitalo S, Itzler RF, Coia ML, Onorato MT, Adeyi BA, Marshall GS, Gothefors L, Campens D, Karvonen A, Watt JP, O'Brien KL, DiNubile MJ, Clark HF, Boslego JW, Offit PA, Heaton PM; Rotavirus Efficacy and Safety Trial (REST) Study Team. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006 Jan 5;354(1):23-33.

Goveia MG, DiNubile MJ, Dallas MJ, Heaton PM, Kuter BJ; REST Study Team. Efficacy of pentavalent human-bovine (WC3) reassortant rotavirus vaccine based on breastfeeding frequency. Pediatr Infect Dis J. 2008 Jul;27(7):656-8.

Rodriguez ZM, Goveia MG, Stek JE, Dallas MJ, Boslego JW, DiNubile MJ, Heaton PM. Concomitant use of an oral live pentavalent human-bovine reassortant rotavirus vaccine with licensed parenteral pediatric vaccines in the United States. Pediatr Infect Dis J. 2007 Mar;26(3):221-7.

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00090233

Study ID Number: 2004_012

ClinicalTrials.gov Identifier: NCT00090233

Health Authority: United States: Food and Drug Administration

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PhRMA Clinical Study Results Database - web-based repository for clinical study results

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