Rotavirus Efficacy and Safety Trial (REST)(V260-006)(COMPLETED)

Verified by: Merck, April 2011
First Received: August 25, 2004 | Last Updated: April 6, 2011 | Phase: Phase 3 | Start Date: January 2001
Overall Status: Completed | Estimated Enrollment: 69274
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This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis...

Brief Summary

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

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
  • 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

  • Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo
    • Time Frame: Within 42 days following any dose of RotaTeq™/placebo
      Safety Issue?: Yes
  • Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination
    • Time Frame: At least 14 days following the 3rd vaccination through the first full rotavirus season
      Safety Issue?: No

Secondary Measures

  • G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus
    • Time Frame: 14 days following the 3rd vaccination
      Safety Issue?: No
  • Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4
    • Time Frame: At least 14 days following the 3rd vaccination
      Safety Issue?: No
  • Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose.
    • Time Frame: At least 14 days following the 3rd vaccination through the first rotavirus season
      Safety Issue?: No
  • Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose
    • Time Frame: At least 14 days following the 3rd vaccination through the first rotavirus season
      Safety Issue?: No
  • Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo
    • Time Frame: 42 days following third dose
      Safety Issue?: No
  • Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin
    • Time Frame: 42 days following third dose
      Safety Issue?: No
  • Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
    • Time Frame: 42 days following third dose
      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 Investigator Information

Lead Investigator: Merck Industry

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.

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

Study ID Number: V260-006

ClinicalTrials.gov Identifier: NCT00090233

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

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