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

Primary Purpose

Rotavirus Gastroenteritis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Rotavirus Vaccine, Live, Oral, Pentavalent
Comparator: Placebo
Rotavirus Vaccine, Live, Oral, Pentavalent
Comparator: Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotavirus Gastroenteritis

Eligibility Criteria

6 Weeks - 47 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Arm Label

    Cohort I - RotaTeq™, Adults

    Cohort I - Placebo, Adults

    Cohort II - RotaTeq™, Children

    Cohort II - Placebo, Children

    Cohort III - RotaTeq™, Infants

    Cohort III - Placebo, Infants

    Arm Description

    Adults randomized to receive a single dose of RotaTeq™.

    Adults randomized to receive a single dose of matching placebo to RotaTeq™.

    Children randomized to receive a single dose of RotaTeq™.

    Children randomized to receive a single dose of matching placebo to RotaTeq™.

    Infants randomized to receive 3 doses of RotaTeq™.

    Infants randomized to receive 3 doses of matching placebo to RotaTeq™.

    Outcomes

    Primary Outcome Measures

    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.
    Number of Serious Adverse Events
    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
    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.

    Full Information

    First Posted
    August 4, 2009
    Last Updated
    October 30, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00953056
    Brief Title
    A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    March 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotavirus Gastroenteritis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    144 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort I - RotaTeq™, Adults
    Arm Type
    Experimental
    Arm Description
    Adults randomized to receive a single dose of RotaTeq™.
    Arm Title
    Cohort I - Placebo, Adults
    Arm Type
    Placebo Comparator
    Arm Description
    Adults randomized to receive a single dose of matching placebo to RotaTeq™.
    Arm Title
    Cohort II - RotaTeq™, Children
    Arm Type
    Experimental
    Arm Description
    Children randomized to receive a single dose of RotaTeq™.
    Arm Title
    Cohort II - Placebo, Children
    Arm Type
    Placebo Comparator
    Arm Description
    Children randomized to receive a single dose of matching placebo to RotaTeq™.
    Arm Title
    Cohort III - RotaTeq™, Infants
    Arm Type
    Experimental
    Arm Description
    Infants randomized to receive 3 doses of RotaTeq™.
    Arm Title
    Cohort III - Placebo, Infants
    Arm Type
    Placebo Comparator
    Arm Description
    Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
    Intervention Type
    Biological
    Intervention Name(s)
    Rotavirus Vaccine, Live, Oral, Pentavalent
    Other Intervention Name(s)
    V260, RotaTeq™
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.
    Intervention Type
    Biological
    Intervention Name(s)
    Rotavirus Vaccine, Live, Oral, Pentavalent
    Other Intervention Name(s)
    V260, RotaTeq™.
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Serious Adverse Events
    Description
    All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.
    Time Frame
    up to 14 days post vaccination
    Title
    Number of Serious Adverse Events
    Description
    The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.
    Time Frame
    14 days post vaccination
    Secondary Outcome Measure Information:
    Title
    Number of Infants With Fecal Vaccine Virus Shedding
    Description
    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.
    Time Frame
    Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Weeks
    Maximum Age & Unit of Time
    47 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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