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

Rotavirus Gastroenteritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953056
• Other study ID #: V260-028
• Secondary ID: 2009_627
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2009
• Last updated: October 30, 2015
• Start date: September 2009
• Est. completion date: March 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 47 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

Intervention

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.
• Comparator: Placebo
Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site