A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)
A Double-Blind, Randomized, Placebo-Controlled, Safety and Tolerability Study of Live Pentavalent Human-Bovine Reassortant Rotavirus Vaccine in Chinese Healthy Adults, Children and Infants
2 other identifiers
interventional
144
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2009
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
April 15, 2011
CompletedNovember 2, 2015
October 1, 2015
6 months
August 4, 2009
March 25, 2011
October 30, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Serious Adverse Events
All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.
up to 14 days post vaccination
Number of Serious Adverse Events
The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.
14 days post vaccination
Secondary Outcomes (1)
Number of Infants With Fecal Vaccine Virus Shedding
Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo
Study Arms (6)
Cohort I - RotaTeq™, Adults
EXPERIMENTALAdults randomized to receive a single dose of RotaTeq™.
Cohort I - Placebo, Adults
PLACEBO COMPARATORAdults randomized to receive a single dose of matching placebo to RotaTeq™.
Cohort II - RotaTeq™, Children
EXPERIMENTALChildren randomized to receive a single dose of RotaTeq™.
Cohort II - Placebo, Children
PLACEBO COMPARATORChildren randomized to receive a single dose of matching placebo to RotaTeq™.
Cohort III - RotaTeq™, Infants
EXPERIMENTALInfants randomized to receive 3 doses of RotaTeq™.
Cohort III - Placebo, Infants
PLACEBO COMPARATORInfants randomized to receive 3 doses of matching placebo to RotaTeq™.
Interventions
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.
Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp and Dohme
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 6, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
November 2, 2015
Results First Posted
April 15, 2011
Record last verified: 2015-10