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An Open-Label, Randomized, Phase I Study in Healthy Male Adults to Evaluate the Safety of a Measles Vaccine (Dry Powder)Administered by Two Devices
This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Subjects will be followed for 180 days for safety.
This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Solicited reactions will be assessed for first 14 days after vaccination and unsolicited adverse events will be assessed till 84 days after vaccination. Subjects will be followed for 180 days for any SAEs.
Age
18 - 45 years
Sex
MALE
Healthy Volunteers
Yes
Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College
Pune, Maharashtra, India
Start Date
March 1, 2012
Primary Completion Date
February 1, 2013
Completion Date
September 1, 2013
Last Updated
March 14, 2018
60
ACTUAL participants
PMV via Puffhaler® device
BIOLOGICAL
PMV via SoloventTM device
BIOLOGICAL
Licensed Subcutaneous Measles Vaccine
BIOLOGICAL
Lead Sponsor
Serum Institute of India Pvt. Ltd.
Collaborators
Data Source & Attribution
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