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

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.

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Key information

Conditions

Rotavirus Gastroenteritis

Age range

6 week–47 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotavirus Vaccine, Live, Oral, Pentavalent

Biological

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 names: V260, RotaTeq™

Comparator: Placebo

Biological

Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.

Primary outcomes

Number of Participants With Serious Adverse Events

Time frame: up to 14 days post vaccination

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

The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.

Secondary outcomes

Number of Infants With Fecal Vaccine Virus Shedding

Time frame: Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Aug 6, 2009
Registry last updated: Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed