Phase 1
Completed N=144
A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)
Rotavirus Gastroenteritis
Source: ClinicalTrials.gov NCT00953056 ↗
Enrolled (actual)
144
Serious AEs
2.1%
Results posted
Apr 2011
Primary outcomePrimary: Number of Participants With Serious Adverse Events — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events |
0; 0; 0; 0; 0; 3 | — |
| PRIMARY Number of Serious Adverse Events |
0; 0; 0; 0; 0; 4 | — |
| SECONDARY Number of Infants With Fecal Vaccine Virus Shedding |
3; 0; 2; 0; 3; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00953056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.