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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed 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). 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.
Sponsor: Serum Institute of India Pvt. Ltd.

Current Primary Outcome:

  • Incidence of Solicited Reactions [ Time Frame: Day 14 ]
    Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.
  • Incidence of Unsolicited Adverse Events Within 84 Days [ Time Frame: Day 84 ]
    Incidence of unsolicited adverse events for a period of 84 days in each group was assessed.
  • Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions [ Time Frame: Day 180 ]
    Incidence of serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period of 180 days in each group was assessed.


Original Primary Outcome:

  • Incidence of Solicited Reactions [ Time Frame: Day 14 ]
    Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group will be assessed.
  • Incidence of Unsolicited Adverse Events Within 84 Days [ Time Frame: Day 84 ]
    Incidence of unsolicited adverse events for a period of 84 days in each group will be assessed.
  • Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions [ Time Frame: Day 180 ]
    Incidence of serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period of 180 days in each group will be assessed.


Current Secondary Outcome:

  • The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies [ Time Frame: Day -7, Day 28 and Day 84 ]
    The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 was assessed.
  • The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre [ Time Frame: Day -7, Day 28 and Day 84 ]
    The proportion of subjects in each group with seroprotective plaque-reduction neutralization test (PRNT) titre on Day -7, Day 28 and Day 84 was assessed.
  • The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG [ Time Frame: Day 28 and Day 84 ]
    The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed.
  • The Proportion of Subjects in Each Group With Seroconversion for PRNT [ Time Frame: Day 28 and Day 84 ]
    The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed.
  • Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies [ Time Frame: Day -7, Day 28 and Day 84 ]
    Geometric Mean Concentration (GMC) for anti-Measles IgG antibodies were measured on Day -7, Day 28 and Day 84 by ELISA using Trinity ELISA Kits for Measles.
  • Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84 [ Time Frame: Day -7, Day 28 and Day 84 ]
    Geometric Mean Titre by Plaque Reduction Neutralization Test were assessed on Day -7, 28 and 84 at CDC, Atlanta. Titers are expressed as IU/ml.


Original Secondary Outcome:

  • The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies [ Time Frame: Day -7, Day 28 and Day 84 ]
    The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 will be assessed.
  • The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre [ Time Frame: Day -7, Day 28 and Day 84 ]
    The proportion of subjects in each group with seroprotective plaque-reduction neutralization test (PRNT) titre on Day -7, Day 28 and Day 84 will be assessed.
  • The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG [ Time Frame: Day 28 and Day 84 ]
    The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 will be assessed.
  • The Proportion of Subjects in Each Group With Seroconversion for PRNT [ Time Frame: Day 28 and Day 84 ]
    The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 will be assessed.
  • Geometric Mean Concentration (GMC) for anti-Measles IgG antibodies [ Time Frame: Day -7, Day 28 and Day 84 ]
    GMCs for anti-Measles IgG antibodies will be measured on Day -7, Day 28 and Day 84.
  • Geometric Mean Titre (GMT) for PRNT on Day -7, 28 and 84 [ Time Frame: Day -7, Day 28 and Day 84 ]
    GMT for PRNT will be assessed on Day -7, 28 and 84.


Information By: Serum Institute of India Pvt. Ltd.

Dates:
Date Received: March 16, 2012
Date Started: March 2012
Date Completion:
Last Updated: November 29, 2014
Last Verified: November 2014