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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rotavirus Gastroenteritis

Intervention / Treatment
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* Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
* Biological: Comparator: Placebo
* Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
* Biological: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 47 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort I - RotaTeq™, Adults<br>Adults randomized to receive a single dose of RotaTeq™. | Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* 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.<br>* Other names: V260, RotaTeq™;|
| Placebo Comparator: Cohort I - Placebo, Adults<br>Adults randomized to receive a single dose of matching placebo to RotaTeq™. | Biological: Comparator: Placebo<br>* Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.<br>|
| Experimental: Cohort II - RotaTeq™, Children<br>Children randomized to receive a single dose of RotaTeq™. | Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* 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.<br>* Other names: V260, RotaTeq™;|
| Placebo Comparator: Cohort II - Placebo, Children<br>Children randomized to receive a single dose of matching placebo to RotaTeq™. | Biological: Comparator: Placebo<br>* Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.<br>|
| Experimental: Cohort III - RotaTeq™, Infants<br>Infants randomized to receive 3 doses of RotaTeq™. | Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* 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.<br>* Other names: V260, RotaTeq™.;|
| Placebo Comparator: Cohort III - Placebo, Infants<br>Infants randomized to receive 3 doses of matching placebo to RotaTeq™. | Biological: Comparator: Placebo<br>* 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.<br>|

What is the study measuring?
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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 |