Status:

COMPLETED

Dose Confirmation Efficacy Study (V260-007)

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Rotavirus Infections

Eligibility:

All Genders

6-12 years

Phase:

PHASE3

Brief Summary

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

Detailed Description

The duration of treatment is 10 months.

Eligibility Criteria

Inclusion

  • Healthy infants

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2004

Estimated Enrollment :

1312 Patients enrolled

Trial Details

Trial ID

NCT00092443

Start Date

September 1 2002

End Date

June 1 2004

Last Update

September 14 2015

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