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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Rotavirus Gastroenteritis

Treatments: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00953056

V260-028

2009_627

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 6 weeks to 47 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 6 patient groups, including a placebo group

Cohort I - RotaTeq™, Adults

Experimental group

Description:

Adults randomized to receive a single dose of RotaTeq™.

Treatment:

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Cohort I - Placebo, Adults

Placebo Comparator group

Description:

Adults randomized to receive a single dose of matching placebo to RotaTeq™.

Treatment:

Biological: Comparator: Placebo

Biological: Comparator: Placebo

Cohort II - RotaTeq™, Children

Experimental group

Description:

Children randomized to receive a single dose of RotaTeq™.

Treatment:

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Cohort II - Placebo, Children

Placebo Comparator group

Description:

Children randomized to receive a single dose of matching placebo to RotaTeq™.

Treatment:

Biological: Comparator: Placebo

Biological: Comparator: Placebo

Cohort III - RotaTeq™, Infants

Experimental group

Description:

Infants randomized to receive 3 doses of RotaTeq™.

Treatment:

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Cohort III - Placebo, Infants

Placebo Comparator group

Description:

Infants randomized to receive 3 doses of matching placebo to RotaTeq™.

Treatment:

Biological: Comparator: Placebo

Biological: Comparator: Placebo