A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers

Study Overview
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Brief Summary
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This is a Phase I study to evaluate the safety and tolerability of the tetravalent rota virus vaccine in healthy Indian adult male volunteers administered a single dose of the vaccine at the highest possible viral concentration in 0.5 mL of vaccine.

Official Title
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Phase I Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Tolerability of a Single Administration (10e6.25 FFU of Each Constituent Serotype Per 0.5 ml) of Live Attenuated Tetravalent (G1-G4) Bovine-human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Adult Males

Conditions
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Rotavirus Gastroenteritis

Intervention / Treatment
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* Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Indian adult male volunteers. No apparent signs or symptoms of ill health. Properly informed about the study and having signed the informed consent form (ICF). In case of the volunteer being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the ICF; Subject available for the entire period of the study and reachable by study staff for post-vaccination follow-up. Exclusion Criteria: Known or suspected impairment of immunological function; Known hypersensitivity to any component of the rotavirus vaccine; Fever, with axillary temperature ≥38.1oC (≥100.5oF); measured by study staff. History of chronic diarrhea; Clinical evidence of active gastrointestinal illness; Receipt of any intramuscular (IM), oral, or intravenous (IV) corticosteroid treatment in the past 30 days Subjects suspected to be HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) positive from the available clinical history Prior receipt of a blood transfusion or blood products, including immunoglobulins; Any subject who cannot be adequately followed for safety; Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Subject unable to maintain diary card

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)<br>* Single dose (0.5 mL) of the vaccine administered orally<br>|
| Placebo Comparator: Group 2<br> | Other: Placebo<br>* Single dose (0.5 mL) of the placebo administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity and causality of all Adverse Events following the dose of vaccine/placebo | The frequency, severity and causality of all solicited and unsolicited adverse events following administration of a single dose of the vaccine as compared to placebo | upto 10 days following administration of vaccine/placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency and the percentage change, as compared to baseline, in the protocol defined laboratory parameters following the single dose of Vaccine/placebo | The frequency, percentage change, as compared to baseline, and causality of all the defined laboratory parameters following administration of a single dose of the vaccine as compared to placebo | Upto 10 days following administration of vaccine/placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety of vaccine