A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices (PMV-001)

March 13, 2018 updated by: Serum Institute of India Pvt. Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: PMV via Puffhaler® Device
The dry powder measles vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used.
Biological: PMV via Puffhaler® device
The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.
EXPERIMENTAL: PMV via SoloventTM device
The dry powder measles vaccine will be administered via a SoloventTM device. A single dose of 10 mg will be used.
Biological: PMV via SoloventTM device
The vaccine will be administered via SoloventTM device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.
ACTIVE_COMPARATOR: Licensed Subcutaneous Measles Vaccine
Licensed measles vaccine will be administered subcutaneously as single dose of 0.5 ml.
Biological: Licensed Subcutaneous Measles Vaccine
This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.
Other Names:
  • SMV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 14
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.
Day 84
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.
Day 180

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Day -7, Day 28 and Day 84
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.
Day -7, Day 28 and Day 84
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.
Day 28 and Day 84
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.
Day 28 and Day 84
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.
Day -7, Day 28 and Day 84
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.
Day -7, Day 28 and Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Serum Institute of India Pvt. Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention
University of Colorado, Boulder

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sharad Agarkhedkar, MD, Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College Hospital & Research Centre, Sant Tukaram Nagar, Pimpri Pune-411018

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PMV-001
  • CTRI/2012/02/002447 (REGISTRY: CLINICAL TRIAL REGISTRY OF INDIA (CTRI))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prophylaxis for the Measles Infection

Clinical Trials on PMV via Puffhaler® device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings