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A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices

Information source: Serum Institute of India Limited
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prophylaxis for the Measles Infection

Intervention: PMV via Puffhaler® device (Biological); PMV via SoloventTM device (Biological); Licensed Subcutaneous Measles Vaccine (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: Serum Institute of India Limited

Official(s) and/or principal investigator(s):
Sharad Agarkhedkar, MD, Principal Investigator, Affiliation: Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College Hospital & Research Centre, Sant Tukaram Nagar, Pimpri Pune-411018

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Incidence of Solicited Reactions

Incidence of Unsolicited Adverse Events Within 84 Days

Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions

Secondary outcome:

The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies

The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre

The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG

The Proportion of Subjects in Each Group With Seroconversion for PRNT

Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies

Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College, Pune, Maharashtra 411018, India
Additional Information

Published Study in Vaccines

Starting date: March 2012
Last updated: November 29, 2014

Page last updated: August 20, 2015

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