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 - PMV

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/02/002447

Enrollment

Registered

2012-02-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Powdered Measles Vaccine: The vaccine will be administered via a PuffhalerÂ®. A single dose of 10 mg will be used. Intervention2: Powdered Measles Vaccine: The vaccine will be administ

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1. Incidence of solicited reactions 2. Incidence of unsolicited adverse events 3. Incidence of serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period of 180 days in each groupTimepoint: 1. 14 days 2. 84 days 3. Throughout 180 days	—

Secondary

Measure	Time frame
Immunogenicity evaluationsTimepoint: On day -7, day 28 and day 84.	—

Countries

India

Contacts

Public ContactDr Prasad Kulkarni

Serum Institute of India Ltd

drpsk@seruminstitute.com91-20-26602384

Outcome results