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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00953056

First received: August 4, 2009

Last updated: April 19, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2009

Last Updated Date

April 19, 2011

Start Date ^ICMJE

September 2009

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants With Serious Adverse Events [ Time Frame: up to 14 days post vaccination ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 14 days post vaccination ] [ Designated as safety issue: Yes ]
The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.

Original Primary Outcome Measures ^ICMJE

Number of serious adverse experiences [ Time Frame: 14 days post vaccination ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00953056 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of Infants With Fecal Vaccine Virus Shedding [ Time Frame: Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo ] [ Designated as safety issue: Yes ]

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.

Original Secondary Outcome Measures ^ICMJE

Fecal vaccine virus shedding rate in infants [ Time Frame: between Day 3 and Day 7 following each of 3 doses of V260/placebo ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Rotavirus Gastroenteritis

Intervention ^ICMJE

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.

Other Name: V260, RotaTeq™
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.

Other Name: V260, RotaTeq™.
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.

Study Arm (s)

Experimental: Cohort I - RotaTeq™, Adults
Adults randomized to receive a single dose of RotaTeq™.

Intervention: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Placebo Comparator: Cohort I - Placebo, Adults
Adults randomized to receive a single dose of matching placebo to RotaTeq™.

Intervention: Biological: Comparator: Placebo
Experimental: Cohort II - RotaTeq™, Children
Children randomized to receive a single dose of RotaTeq™.

Intervention: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Placebo Comparator: Cohort II - Placebo, Children
Children randomized to receive a single dose of matching placebo to RotaTeq™.

Intervention: Biological: Comparator: Placebo
Experimental: Cohort III - RotaTeq™, Infants
Infants randomized to receive 3 doses of RotaTeq™.

Intervention: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Placebo Comparator: Cohort III - Placebo, Infants
Infants randomized to receive 3 doses of matching placebo to RotaTeq™.

Intervention: Biological: Comparator: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

144

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

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

Gender

Both

Ages

6 Weeks to 47 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00953056

Other Study ID Numbers ^ICMJE

V260-028, 2009_627

Has Data Monitoring Committee

Responsible Party

Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top