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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00953056
First received: August 4, 2009
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Rotavirus Gastroenteritis
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Biological: Comparator: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 144
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort I - RotaTeq™, Adults
Adults randomized to receive a single dose of RotaTeq™.
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™
Placebo Comparator: Cohort I - Placebo, Adults
Adults randomized to receive a single dose of matching placebo to RotaTeq™.
Biological: Comparator: Placebo
Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.
Experimental: Cohort II - RotaTeq™, Children
Children randomized to receive a single dose of RotaTeq™.
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™
Placebo Comparator: Cohort II - Placebo, Children
Children randomized to receive a single dose of matching placebo to RotaTeq™.
Biological: Comparator: Placebo
Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.
Experimental: Cohort III - RotaTeq™, Infants
Infants randomized to receive 3 doses of RotaTeq™.
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™.
Placebo Comparator: Cohort III - Placebo, Infants
Infants randomized to receive 3 doses of matching placebo to 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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 47 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953056

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00953056     History of Changes
Other Study ID Numbers: V260-028, 2009_627
Study First Received: August 4, 2009
Results First Received: March 25, 2011
Last Updated: August 8, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014