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A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)

NCT00953056 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2015-11-02

Study results available
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Summary

This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages 6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then participants in Cohort III receiving 3 doses of RotaTeq™/placebo. The primary investigator and the Ethics Review Committee will review blinded safety data and make decision based on their best clinical judgment to move study forward between cohorts. Duration for the entire study will be approximately 6-9 months.

Conditions

  • Rotavirus Gastroenteritis

Interventions

BIOLOGICAL

Rotavirus Vaccine, Live, Oral, Pentavalent

Single 2.0 mL dose V260 (RotaTeq™) administered orally at enrollment. The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.

BIOLOGICAL

Comparator: Placebo

Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.

BIOLOGICAL

Rotavirus Vaccine, Live, Oral, Pentavalent

Three 2.0 mL doses of RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age. The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.

BIOLOGICAL

Comparator: Placebo

Three 2.0 mL doses of matching placebo to RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
47 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-03-31
Completion
2010-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00953056 on ClinicalTrials.gov