A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Intervention: Rotavirus Vaccine, Live, Oral, Pentavalent; Comparator: Placebo; Rotavirus Vaccine, Live, Oral, Pentavalent; Comparator: Placebo
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.; Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.; 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.; 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.
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 144.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 47 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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