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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00953056
First received: August 4, 2009
Last updated: November 3, 2014
Last verified: November 2014

August 4, 2009
November 3, 2014
September 2009
March 2010   (final data collection date for primary outcome measure)
  • 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.
Number of serious adverse experiences [ Time Frame: 14 days post vaccination ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00953056 on ClinicalTrials.gov Archive Site
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.
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 ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Rotavirus Gastroenteritis
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
6 Weeks to 47 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00953056
V260-028, 2009_627
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

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