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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.
The vaccine will be administered via SoloventTM device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.
This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.
Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College
Pune, Maharashtra, India
Incidence of Solicited Reactions
Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.
Time frame: Day 14
Incidence of Unsolicited Adverse Events Within 84 Days
Incidence of unsolicited adverse events for a period of 84 days in each group was assessed.
Time frame: Day 84
Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions
Incidence of serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period of 180 days in each group was assessed.
Time frame: Day 180
The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies
The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 was assessed.
Time frame: Day -7, Day 28 and Day 84
The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre
The proportion of subjects in each group with seroprotective plaque-reduction neutralization test (PRNT) titre on Day -7, Day 28 and Day 84 was assessed.
Time frame: Day -7, Day 28 and Day 84
The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG
The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed.
Time frame: Day 28 and Day 84
The Proportion of Subjects in Each Group With Seroconversion for PRNT
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The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed.
Time frame: Day 28 and Day 84
Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies
Geometric Mean Concentration (GMC) for anti-Measles IgG antibodies were measured on Day -7, Day 28 and Day 84 by ELISA using Trinity ELISA Kits for Measles.
Time frame: Day -7, Day 28 and Day 84
Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84
Geometric Mean Titre by Plaque Reduction Neutralization Test were assessed on Day -7, 28 and 84 at CDC, Atlanta. Titers are expressed as IU/ml.
Time frame: Day -7, Day 28 and Day 84