A clinical trial to assess the Safety of a Measles Vaccine (Dry Powder) administered by two different devices.
- Registration Number
- CTRI/2012/02/002447
- Lead Sponsor
- Serum Institute of India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. Male adults of age of 18-45 years.
2. Measles immune, as determined by IgG antibody levels.
3. Healthy as supported by medical history, physical examination and laboratory evaluation on preset parameters.
4. Signed informed consent for participation in trial and for HIV screening.
5. Expressed interest and availability to fulfill the study requirements.
6. Willing not to have other experimental vaccination from â??30 days to 180 days after study vaccination.
1.Medical history of immunodeficiency/suppression or subject with history of close contact with
immunocompromised/ immunosuppressed person.
2. Chronic administration of immunosuppressants or other immune modifying agents
3. Acute febrile illness or suspected measles illness or acute infectious disease
4. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, neurological, hepatic or renal functional abnormality which in the opinion of the investigator, might interfere with the study objectives
5. History of seizure disorders
6. Major congenital defects
7. Thrombocytopenia or known bleeding disorders 8. History of a previous severe allergic reaction
9. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen
10. Known hypersensitivity to any component of the
study vaccine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Incidence of solicited reactions <br/ ><br>2. Incidence of unsolicited adverse events <br/ ><br>3. Incidence of serious adverse events (SAEs) and new <br/ ><br>onset chronic medical conditions throughout the entire study period of 180 days in each groupTimepoint: 1. 14 days <br/ ><br>2. 84 days <br/ ><br>3. Throughout 180 days
- Secondary Outcome Measures
Name Time Method Immunogenicity evaluationsTimepoint: On day -7, day 28 and day 84.