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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2012/02/002447 | Registry Identifier | CLINICAL TRIAL REGISTRY OF INDIA (CTRI) |
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| Name | Class |
|---|---|
| University of Colorado, Boulder | OTHER |
| Centers for Disease Control and Prevention | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMV via Puffhaler® Device | Experimental | The dry powder measles vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used. |
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| PMV via SoloventTM device | Experimental | The dry powder measles vaccine will be administered via a SoloventTM device. A single dose of 10 mg will be used. |
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| Licensed Subcutaneous Measles Vaccine | Active Comparator | Licensed measles vaccine will be administered subcutaneously as single dose of 0.5 ml. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMV via Puffhaler® device | Biological | The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Solicited Reactions | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day -7, Day 28 and Day 84 |
| The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharad Agarkhedkar, MD | Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College Hospital & Research Centre, Sant Tukaram Nagar, Pimpri Pune-411018 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College | Pune | Maharashtra | 411018 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25446830 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dry Powdered Measles Vaccine Via a Puffhaler® Device | Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used. N=20 |
| FG001 | Dry Powdered Measles Vaccine Via SoloventTM Device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| PMV via SoloventTM device | Biological | The vaccine will be administered via SoloventTM device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used. |
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| Licensed Subcutaneous Measles Vaccine | Biological | This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously. |
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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 | 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 | 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 | 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 | 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 |
Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used. N=20 |
| FG002 | Licensed Subcutaneous Measles Vaccine | Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously. N=20 |
| COMPLETED |
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| NOT COMPLETED |
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60 healthy adult males of 18 to 45 years
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| ID | Title | Description |
|---|---|---|
| BG000 | PMV Puffhaler® | Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used. N=20 |
| BG001 | PMV SoloventTM | Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used. N=20 |
| BG002 | Subcutaneous Meales Vaccine | Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously. N=20 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex/Gender, Customized | Number | Male participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Incidence of Solicited Reactions | Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed. | Intention-To-Treat (ITT) Population included all subjects who received at least one dose of study vaccine and had at least one post-baseline assessment, regardless of whether they adhered to the study eligibility criteria or whether their study medication administration and study procedure visits are within the protocol-specified windows. | Posted | Number | participants | Day 14 |
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| Primary | Incidence of Unsolicited Adverse Events Within 84 Days | Incidence of unsolicited adverse events for a period of 84 days in each group was assessed. | Intention-To-Treat (ITT) Population was used for safety analysis. | Posted | Number | participants | Day 84 |
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| Primary | 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. | Intention-To-Treat (ITT) Population was used for safety and immunogenicity analysis. ITT population included subjects who had blood drawn to confirm a measles protective titer at Day -7 and met all inclusion/ exclusion criteria and did not receive a vaccine forbidden in the study protocol within the previous 30 days. | Posted | Number | participants | Day 180 |
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| Secondary | 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. | Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples. | Posted | Number | percentage of participants | Day -7, Day 28 and Day 84 |
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| Secondary | 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. | Per Protocol (PP) Population was used for the Immunogenicity analysis which included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 blood samples. | Posted | Number | percentage of participants | Day -7, Day 28 and Day 84 |
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| Secondary | 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. | Per Protocol Population was used for the Immunogenicity analysis which included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 blood samples. | Posted | Number | percentage of participants | Day 28 and Day 84 |
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| Secondary | 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. | Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples. | Posted | Number | percentage of participants | Day 28 and Day 84 |
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| Secondary | 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. | Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples. | Posted | Geometric Mean | 95% Confidence Interval | IU/ml | Day -7, Day 28 and Day 84 |
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| Secondary | 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. | Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples. | Posted | Geometric Mean | 95% Confidence Interval | IU/ml | Day -7, Day 28 and Day 84 |
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Day 84
Occurrence of unsolicited adverse events was monitored till day 84 after randomization. No unsolicited adverse events were reported. Subjects had study site visits till day 84. Day 180 visit was telephonic communication with the study subjects to assess if any serious adverse events occurred from day 84 till day 180 after randomization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Dry Powdered Measles Vaccine Via a Puffhaler® Device | Dry Powdered Measles Vaccine: The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used. N=20 | 0 | 20 | 0 | 20 | ||
| EG001 | Dry Powdered Measles Vaccine Via SoloventTM Device | Dry Powdered Measles Vaccine: The vaccine will be administered via SoloventTM device. A single dose of 10 mg will be used. N=20 | 0 | 20 | 0 | 20 | ||
| EG002 | Licensed Subcutaneous Measles Vaccine | 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. N=20 | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Prasad Kulkarni | SERUM INSTITUTE OF INDIA LIMITED | +912026602384 | drpsk@seruminstitute.com |
| Between 18 and 65 years |
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| >=65 years |
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