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Rotavirus Efficacy and Safety Trial (REST)
This study has been completed.
First Received: August 25, 2004   Last Updated: May 4, 2009   History of Changes
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00090233
  Purpose

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


Condition Intervention Phase
Rotavirus Infections
 Biological: V260, rotavirus vaccine, live, oral, pentavalent / Duration of Treatment: 3 years
 Phase III

MedlinePlus related topics: Rotavirus Infections
Drug Information available for: RotaTeq
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants

Further study details as provided by Merck:

Primary Outcome Measures:
  • Occurance of clinical rotavirus disease caused by serotypes G1, G2, G3 and G4 that occurs 14 days following 3rd dose; serum neutralizing antibodies (SNA) against rotavirus; risk of intussusception within 42 days following any dose

Estimated Enrollment: 60000
Study Start Date: December 2000
  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

- Healthy infants

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090233

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:
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.
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.

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2004_012, V260-006
Study First Received: August 25, 2004
Last Updated: May 4, 2009
ClinicalTrials.gov Identifier: NCT00090233     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Rotavirus Infections
Healthy

Additional relevant MeSH terms:
Virus Diseases
RNA Virus Infections
Rotavirus Infections
Reoviridae Infections
Infection

ClinicalTrials.gov processed this record on May 06, 2009



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