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

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.

Inclusion Criteria:

• Male adults of age of 18-45 years.
• Measles immune, as determined by IgG antibody levels.
• Healthy as supported by medical history, physical examination and laboratory evaluation on preset parameters.
• Signed informed consent for participation in trial and for HIV screening.

Exclusion Criteria:

• Medical history of immunodeficiency/suppression or subject with history of close contact with immunocompromised/ immunosuppressed person.
• Chronic administration of immunosuppressants or other immune modifying agents
• Acute febrile illness or suspected measles illness or acute infectious disease
• 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
• History of seizure disorders
• Major congenital defects
• Thrombocytopenia or known bleeding disorders 8. History of a previous severe allergic reaction
• Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen
• Known hypersensitivity to any component of the study vaccine