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

Phase 1

Completed

• Conditions: Rotavirus Gastroenteritis
• Interventions: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

• Registration Number: NCT00953056
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Study Start: 2009-09
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-03-25
• Results First Submitted QC: 2011-03-25
• Results First Posted: 2011-04-15
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Healthy adults ages 19 to 47 years for Cohort I
• Healthy children ages 2 to 6 years for Cohort II
• Healthy infants ages 6 to 12 weeks for Cohort III
• Negative pregnancy test for females in Cohort I
• Signed Informed Consent Forms (ICFs)

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Exclusion Criteria

• Participants in Cohorts I and II receiving any vaccine 14 days before or anticipated after study vaccine
• Participants in Cohort III receiving non-concomitant live vaccines 14 days before or after study vaccine
• Prior administration of any rotavirus vaccine
• Elevated temperature, with axillary temperature ≥37.1 Degrees C 24 hours before study vaccine
• Prior or active gastrointestinal illnesses, immunodeficiency
• Any condition which may interfere with evaluation of study objectives or make participation in the study unsafe for the participant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort II - RotaTeq™, Children	Rotavirus Vaccine, Live, Oral, Pentavalent	Children randomized to receive a single dose of RotaTeq™.
Cohort I - RotaTeq™, Adults	Rotavirus Vaccine, Live, Oral, Pentavalent	Adults randomized to receive a single dose of RotaTeq™.
Cohort III - RotaTeq™, Infants	Rotavirus Vaccine, Live, Oral, Pentavalent	Infants randomized to receive 3 doses of RotaTeq™.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Events	up to 14 days post vaccination	All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.
Number of Serious Adverse Events	14 days post vaccination	The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.

Secondary Outcome Measures

Name	Time	Method
Number of Infants With Fecal Vaccine Virus Shedding	Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo	Fecal shedding of vaccine rotavirus in Cohort III (infants) was evaluated by determining the number of participants whose stool was positive by both (1) the Enzyme-linked Immunosorbent Assay (EIA) to detect the rotavirus antigen, and (2) PCR VP6 Genotyping (a polymerase chain reaction assay specific for rotavirus genome 6, coding for the VP6 protein of the vaccine virus). For analysis, two stool samples were collected per participant on separate days between Day 3 and Day 7 following each vaccination dose.