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Completed

NCT Number: NCT00092443

Dose Confirmation Efficacy Study (V260-007)

This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.

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Key information

Conditions

Rotavirus Infections Infections RNA Virus Infections Reoviridae Infections Virus Diseases

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The duration of treatment is 10 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy infants

Exclusion criteria

  • History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
  • Known or suspected problems with immune system
  • Fever at time of immunization
  • Prior administration of a rotavirus vaccine
  • History of known prior rotavirus disease
  • Chronic diarrhea, or failure to thrive

Treatment and study plan

RotaTeq™, rotavirus vaccine, live, oral, pentavalent

Biological

Three doses of RotaTeq™ administered 28 to 70 days apart.

Other names: V260

Comparator: Placebo matching RotaTeq™

Biological

Placebo matching RotaTeq™ administered 28 to 70 days apart.

Primary outcomes

  1. Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.

    Time frame: At least 14 days following the 3rd vaccination

    G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition

Secondary outcomes

  1. Number of Subjects With ≥3 Fold Rise in Antibody Titer

    Time frame: 14 days following the 3rd vaccination

    Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Sep 27, 2004
Registry last updated
Sep 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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