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CompletedNCT01557699PMV-001Updated Mar 14, 2018Results posted

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

A Phase 1 interventional study of PMV via Puffhaler® device and PMV via SoloventTM device in Prophylaxis for the Measles Infection, sponsored by Serum Institute of India Pvt. Ltd.. Completed at 1 site in India. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-14.

Sponsored by Serum Institute of India Pvt. Ltd. · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prophylaxis for the Measles Infection

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03

In context

Measles

120 studies on the registry are indexed under Measles; 17 are open to participants now.

This study's enrollment of 60 is below the median of 540 across 93 interventional studies indexed under Measles.

Browse Measles studies →

Lead sponsor

Serum Institute of India Pvt. Ltd. is the lead sponsor of 25 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • BiologicalPMV 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.

  • BiologicalPMV 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.

  • BiologicalLicensed 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.

    Also known as: SMV

06

What researchers measure

Primary outcomes

  1. Incidence of Solicited Reactions

    Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.

    Time frame: Day 14

  2. Incidence of Unsolicited Adverse Events Within 84 Days

    Incidence of unsolicited adverse events for a period of 84 days in each group was assessed.

    Time frame: Day 84

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

    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.

    Time frame: Day 180

Secondary outcomes

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

    The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 was assessed.

    Time frame: Day -7, Day 28 and Day 84

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

    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.

    Time frame: Day -7, Day 28 and Day 84

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

    The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed.

    Time frame: Day 28 and Day 84

  4. The Proportion of Subjects in Each Group With Seroconversion for PRNT

    The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed.

    Time frame: Day 28 and Day 84

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

    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.

    Time frame: Day -7, Day 28 and Day 84

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

    Time frame: Day -7, Day 28 and Day 84

07

Results

Posted Dec 1, 2014

Participant flow

Participant flow — Overall Study
MilestoneDry Powdered Measles Vaccine Via a Puffhaler® DeviceDry Powdered Measles Vaccine Via SoloventTM DeviceLicensed Subcutaneous Measles Vaccine
Started202020
Completed202020
Not completed000

Outcome measures

PrimaryIncidence of Solicited Reactions

Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.

Time frame:
Day 14
Reported as:
Number · participants
Incidence of Solicited Reactions
participantsPMV Puffhaler®PMV SoloventTMSubcutaneous Meales Vaccine
Incidence of Solicited Reactions000
PrimaryIncidence of Unsolicited Adverse Events Within 84 Days

Incidence of unsolicited adverse events for a period of 84 days in each group was assessed.

Time frame:
Day 84
Reported as:
Number · participants
Incidence of Unsolicited Adverse Events Within 84 Days
participantsDry Powdered Measles Vaccine Via a Puffhaler® DeviceDry Powdered Measles Vaccine Via SoloventTM DeviceLicensed Subcutaneous Measles Vaccine
Incidence of Unsolicited Adverse Events Within 84 Days000
PrimaryIncidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions

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.

Time frame:
Day 180
Reported as:
Number · participants
Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions
participantsDry Powdered Measles Vaccine Via a Puffhaler® DeviceDry Powdered Measles Vaccine Via SoloventTM DeviceLicensed Subcutaneous Measles Vaccine
Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions000
SecondaryThe Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies

The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 was assessed.

Time frame:
Day -7, Day 28 and Day 84
Reported as:
Number · percentage of participants
The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies
percentage of participantsDry Powdered Measles Vaccine Via a Puffhaler® DeviceDry Powdered Measles Vaccine Via SoloventTM DeviceLicensed Subcutaneous Measles Vaccine
The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies100100100
SecondaryThe Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre

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.

Time frame:
Day -7, Day 28 and Day 84
Reported as:
Number · percentage of participants
The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre
percentage of participantsDry Powdered Measles Vaccine Via a Puffhaler® DeviceDry Powdered Measles Vaccine Via SoloventTM DeviceLicensed Subcutaneous Measles Vaccine
The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre10010095
SecondaryThe Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG

The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed.

Time frame:
Day 28 and Day 84
Reported as:
Number · percentage of participants
The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG
percentage of participantsDry Powdered Measles Vaccine Via a Puffhaler® DeviceDry Powdered Measles Vaccine Via SoloventTM DeviceLicensed Subcutaneous Measles Vaccine
at day 28452025
at day 84554535
SecondaryThe Proportion of Subjects in Each Group With Seroconversion for PRNT

The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed.

Time frame:
Day 28 and Day 84
Reported as:
Number · percentage of participants
The Proportion of Subjects in Each Group With Seroconversion for PRNT
percentage of participantsDry Powdered Measles Vaccine Via a Puffhaler® DeviceDry Powdered Measles Vaccine Via SoloventTM DeviceLicensed Subcutaneous Measles Vaccine
Day 28452530
Day 84303025
SecondaryGeometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies

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.

Time frame:
Day -7, Day 28 and Day 84
Reported as:
Geometric mean · IU/ml
Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies
IU/mlDry Powdered Measles Vaccine Via a Puffhaler® DeviceDry Powdered Measles Vaccine Via SoloventTM DeviceLicensed Subcutaneous Measles Vaccine
Baseline (Day-7)0.91 (0.63 to 1.33)1.31 (0.93 to 1.84)0.86 (0.57 to 1.32)
Day 281.46 (1.06 to 2.01)1.49 (1.13 to 1.96)1.03 (0.86 to 1.23)
Day 841.71 (1.31 to 2.22)2.14 (1.72 to 2.68)1.45 (1.07 to 1.95)
SecondaryGeometric Mean Titre (GMT) by PRNT on Day -7, 28 and 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.

Time frame:
Day -7, Day 28 and Day 84
Reported as:
Geometric mean · IU/ml
Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84
IU/mlDry Powdered Measles Vaccine Via a Puffhaler® DeviceDry Powdered Measles Vaccine Via SoloventTM DeviceLicensed Subcutaneous Measles Vaccine
Baseline (Day -7)1914.3 (826.95 to 4431.6)1479.5 (768.41 to 2848.6)2010.4 (1033.6 to 3910.5)
Day 282626.5 (1719.7 to 4011.4)1569.1 (937.44 to 2626.4)1789.7 (1047.8 to 3057.0)
Day 841789.5 (966.32 to 3313.9)1526.5 (824.95 to 2824.8)1152.2 (669.71 to 1982.2)

Adverse events

Collected over Day 84. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dry Powdered Measles Vaccine Via a Puffhaler® Device—0/20 (0%)0/20 (0%)
Dry Powdered Measles Vaccine Via SoloventTM Device—0/20 (0%)0/20 (0%)
Licensed Subcutaneous Measles Vaccine—0/20 (0%)0/20 (0%)

Baseline characteristics

60 healthy adult males of 18 to 45 years

Age, Continuous
Age, Continuous(years)PMV Puffhaler®PMV SoloventTMSubcutaneous Meales VaccineTotal
Mean28 ± 730 ± 628 ± 728.67 ± 6.67
Age, Categorical
Age, Categorical(Participants)PMV Puffhaler®PMV SoloventTMSubcutaneous Meales VaccineTotal
<=18 years0000
Between 18 and 65 years20202060
>=65 years0000
Sex/Gender, Customized
Sex/Gender, Customized(Male participants)PMV Puffhaler®PMV SoloventTMSubcutaneous Meales VaccineTotal
Number20202060
Region of Enrollment
Region of Enrollment(participants)PMV Puffhaler®PMV SoloventTMSubcutaneous Meales VaccineTotal
India20202060
08

Study locations

1 site
  • Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College
    Pune, Maharashtra 411018, India
09

References and documents

Publications

  • MVDP author group; Cape S, Chaudhari A, Vaidya V, Mulay R, Agarkhedkar S, Shermer C, Collins M, Anderson R, Agarkhedkar S, Kulkarni PS, Winston S, Sievers R, Dhere RM, Gunale B, Powell K, Rota PA, Papania M. Safety and immunogenicity of dry powder measles vaccine administered by inhalation: a randomized controlled Phase I clinical trial. Vaccine. 2014 Nov 28;32(50):6791-7. doi: 10.1016/j.vaccine.2014.09.071. Epub 2014 Oct 22. PubMed 25446830 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01557699
Lead sponsor
Serum Institute of India Pvt. Ltd.
Collaborators
University of Colorado, Boulder, Centers for Disease Control and Prevention
Responsible party
Sponsor
First posted
Mar 19, 2012
Start date
Mar 2012
Primary completion
Feb 2013
Completion
Sep 2013
Results posted
Dec 1, 2014
Last update
Mar 14, 2018

Study contacts

Sharad Agarkhedkar, MD
principal investigator · Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College Hospital & Research Centre, Sant Tukaram Nagar, Pimpri Pune-411018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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