Trials / Completed
CompletedNCT01557699
A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Serum Institute of India Pvt. Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PMV via Puffhaler® device | The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used. |
| BIOLOGICAL | PMV via SoloventTM device | The vaccine will be administered via SoloventTM device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used. |
| BIOLOGICAL | Licensed Subcutaneous Measles Vaccine | This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously. |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2013-02-01
- Completion
- 2013-09-01
- First posted
- 2012-03-19
- Last updated
- 2018-03-14
- Results posted
- 2014-12-01
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT01557699. Inclusion in this directory is not an endorsement.