CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
PMV via Puffhaler® device +2 morebiological
Likely dose
PMV via Puffhaler® device 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01557699
NCT01557699Phase 1Completed
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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

Serum Institute of India Pvt. Ltd.·interventional·Posted Mar 19, 2012·Updated Mar 14, 2018

In Brief

A Phase 1 clinical trial evaluating PMV via Puffhaler® device, PMV via SoloventTM device, and 1 other intervention for Prophylaxis for the Measles Infection. Completed, enrolled 60 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProphylaxis for the Measles Infection
CountriesIndia
CollaboratorsUniversity of Colorado, Boulder, Centers for Disease Control and Prevention

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 19, 2012
Enrollment StartMar 1, 2012
Primary CompletionFeb 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.3 years ago

Interventions

PMV via Puffhaler® devicebiological

The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.

PMV via SoloventTM devicebiological

The vaccine will be administered via SoloventTM device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.

Licensed Subcutaneous Measles Vaccinebiological

This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.