Rotavirus Gastroenteritis
Conditions
Keywords
Safety of vaccine
Brief summary
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.
Interventions
BIOLOGICALLive Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)
Single dose (0.5 mL) of the vaccine administered orally
OTHERPlacebo
Single dose (0.5 mL) of the placebo administered orally
Sponsors
Shantha Biotechnics Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity and causality of all Adverse Events following the dose of vaccine/placebo | upto 10 days following administration 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The frequency and the percentage change, as compared to baseline, in the protocol defined laboratory parameters following the single dose of Vaccine/placebo | Upto 10 days following administration 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 |
Countries
India
Outcome results
None listed