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.

Study Overview

• Status: Completed
• Conditions: Rotavirus Gastroenteritis
• Intervention / Treatment: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Comparator: Placebo; Biological: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 47 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort I - RotaTeq™, Adults; Adults randomized to receive a single dose of RotaTeq™.	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 Names: V260, RotaTeq™; 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 Names: V260, RotaTeq™.
Placebo Comparator: Cohort I - Placebo, Adults; Adults randomized to receive a single dose of matching placebo to RotaTeq™.	Biological: Comparator: Placebo; Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.; 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 II - RotaTeq™, Children; Children randomized to receive a single dose of RotaTeq™.	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 Names: V260, RotaTeq™; 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 Names: V260, RotaTeq™.
Placebo Comparator: Cohort II - Placebo, Children; Children randomized to receive a single dose of matching placebo to RotaTeq™.	Biological: Comparator: Placebo; Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.; 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 III - RotaTeq™, Infants; Infants randomized to receive 3 doses of RotaTeq™.	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 Names: V260, RotaTeq™; 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 Names: V260, RotaTeq™.
Placebo Comparator: Cohort III - Placebo, Infants; Infants randomized to receive 3 doses of matching placebo to RotaTeq™.	Biological: Comparator: Placebo; Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 14 days post vaccination
Number of Serious Adverse Events	The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.	14 days post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: August 4, 2009
• First Submitted That Met QC Criteria: August 5, 2009
• First Posted (Estimate): August 6, 2009

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 30, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: V260-028; 2009_627