Skip to main content
OpenTrials
Completed

NCT Number: NCT00718237

Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)

The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rotavirus Digestive System Diseases Gastroenteritis Gastrointestinal Diseases

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age

Exclusion criteria

  • History Of Known Prior Rotavirus Gastroenteritis
  • Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period

Treatment and study plan

Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)

Biological

Rotateq orally administered 3 times

Other names: RotaTeq™, V260

Comparator: Comparator: Placebo (unspecified)

Biological

Placebo orally administered 3 times

Primary outcomes

  1. Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A

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

    Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition

Secondary outcomes

  1. Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A

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

    Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe.

  2. Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A

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

    Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of V260 in Healthy Infants in Japan

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 18, 2008
Registry last updated
Apr 13, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.