CTRI/2012/02/002447
Completed
Phase 1
An Open-Label, Randomized, Phase I Study in Healthy MaleAdults to Evaluate the Safety of a Measles Vaccine (Dry Powder)Administered by Two Devices - PMV
Serum Institute of India Limited0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Serum Institute of India Limited
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
A Phase I, open label trial in healthy subjects to evaluate the central nervous receptor occupancy of pipamperone at the 5-HT2A and D2 receptor by means of Positron Emission Tomography.depressionmajor depressive disorder10027946NL-OMON34843PharmaNeuroBoost NV10
Suspended
Phase 1
Drug interaction assessment of GSK3882347 in healthy participants aged 18 to 65 yearsHealthy volunteer drug interaction studyNot ApplicableISRCTN16147016GlaxoSmithKline (United Kingdom)30
Completed
Phase 1
A Phase I, Randomised, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Doses of ATL1102 Alone and in Combination with G-CSF in Healthy VolunteersStem cell mobilisationBlood - Haematological diseasesACTRN12614000200684Antisense Therapeutics10
Unknown
Phase 1
A Phase I, Open-label, Non-randomized Study, to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With Cisplatin Plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese Patients With Previously Untreated Locally Advanced or Metastatic Unresectable Gastric CancerGastric CancerJPRN-jRCT2080220881AstraZeneca
Active, not recruiting
Phase 1
Study that tested S64315 plus different standard treatments in patients with breast cancerEUCTR2019-000998-23-ESInstitut de Recherches Internationales Servier