CTRI Number	CTRI/2012/02/002447 [Registered on: 24/02/2012] Trial Registered Prospectively
Last Modified On:	22/11/2014
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study Modification(s)	Vaccine Medical Device
Study Design	Randomized, Parallel Group, Active Controlled Trial
Public Title of Study Modification(s)	A clinical trial to assess the Safety of a Measles Vaccine (Dry Powder) administered by two different devices.
Scientific Title of Study Modification(s)	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
Secondary IDs if Any	Secondary ID  Registry  PMV-001  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Sharad Agarkhedkar  Address  Padmashree Dr. D. Y. Patil Medical College Hospital, Pimpri Pune MAHARASHTRA 411018 India  Phone  91-20-24459570   Fax  91-20-27420439   Email  ashalaka@rediffmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Prasad Kulkarni  Address  212/2, Off Soli Poonawalla Road, Hadapsar, Pune MAHARASHTRA 411028 India  Phone  91-20-26602384   Fax  91-20-26993945   Email  drpsk@seruminstitute.com
Details Contact Person Public Query Modification(s)	Name  Dr Prasad Kulkarni  Address  212/2, Off Soli Poonawalla Road, Hadapsar, Pune MAHARASHTRA 411028 India  Phone  91-20-26602384   Fax  91-20-26993945   Email  drpsk@seruminstitute.com
Source of Monetary or Material Support	Serum Institute of India Limited, Pune (SIIL)
Primary Sponsor Modification(s)	Name  Serum Institute of India Limited  Address  212-2, Off Soli Poonawalla Road, Hadapsar, Pune - 411028  Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  Nil
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Sharad Agarkhedkar  Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College, Pune  Padmashree Dr. D. Y. Patil Medical College, Pimpri, Pune - 411028 Pune   91-20-24459570 91-20-27420439 ashalaka@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee of Dr. D. Y. Patil Medical College Hospital, Pimpri, Pune, Maharashtra, India.  Approved
Regulatory Clearance Status from DCGI Modification(s)	Status  Approved/Obtained
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Healthy Human Volunteers  Prevention of Measles infection
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  Powdered Measles Vaccine   The vaccine will be administered via a Puffhaler®. A single dose of 10 mg will be used.   Intervention  Powdered Measles Vaccine   The vaccine will be administered via SoloventTM device. A single dose of 10 mg will be used.   Comparator Agent  Subcutaneous Measles Vaccine (SMV)  This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.
Inclusion Criteria Modification(s)	Age From  18.00 Year(s) Age To  45.00 Year(s) Gender  Male  Details  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 –30 days to 180 days after study vaccination.
ExclusionCriteria	Details  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.
Method of Generating Random Sequence Modification(s)	Permuted block randomization, fixed
Method of Concealment Modification(s)	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking Modification(s)	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  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 group  1. 14 days 2. 84 days 3. Throughout 180 days
Secondary Outcome	Outcome  TimePoints  Immunogenicity evaluations   On day -7, day 28 and day 84.
Target Sample Size Modification(s)	Total Sample Size="60" Sample Size from India="60"
Phase of Trial	Phase 1
Date of First Enrollment (India) Modification(s)	29/02/2012
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial Modification(s)	Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	Safety and immunogenicity of dry powder measles vaccine administered by inhalation: A randomized controlled Phase I clinical trial.Vaccine 32 (2014) 6791–6797
Brief Summary Modification(s)	This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be given single dose of either PMV by Puffhaler®, PMV by SoloventTM or licensed measles vaccine by subcutaneous route (SMV). Subjects will be followed for 180 days for safety.