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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
20
Single dose (0.5 mL) of the vaccine administered orally
Single dose (0.5 mL) of the placebo administered orally
Christian Medical College
Vellore, Tamil Nadu, India
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
Time frame: upto 10 days following administration of vaccine/placebo
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
Time frame: Upto 10 days following administration of vaccine/placebo
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