Trial Outcomes & Findings for A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices (NCT NCT01557699)
NCT ID: NCT01557699
Last Updated: 2018-03-14
Results Overview
Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.
COMPLETED
PHASE1
60 participants
Day 14
2018-03-14
Participant Flow
Participant milestones
| Measure |
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
|
Dry Powdered Measles Vaccine Via SoloventTM Device
Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
N=20
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices
Baseline characteristics by cohort
| Measure |
PMV Puffhaler®
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
N=20
|
PMV SoloventTM
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
N=20
|
Subcutaneous Meales Vaccine
n=20 Participants
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
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 7 • n=5 Participants
|
30 years
STANDARD_DEVIATION 6 • n=7 Participants
|
28 years
STANDARD_DEVIATION 7 • n=5 Participants
|
28.67 years
STANDARD_DEVIATION 6.67 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex/Gender, Customized
|
20 Male participants
n=5 Participants
|
20 Male participants
n=7 Participants
|
20 Male participants
n=5 Participants
|
60 Male participants
n=4 Participants
|
|
Region of Enrollment
India
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: 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.
Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.
Outcome measures
| Measure |
PMV Puffhaler®
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
|
PMV SoloventTM
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
|
Subcutaneous Meales Vaccine
n=20 Participants
Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
|
|---|---|---|---|
|
Incidence of Solicited Reactions
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 84Population: Intention-To-Treat (ITT) Population was used for safety analysis.
Incidence of unsolicited adverse events for a period of 84 days in each group was assessed.
Outcome measures
| Measure |
PMV Puffhaler®
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
|
PMV SoloventTM
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
|
Subcutaneous Meales Vaccine
n=20 Participants
Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
|
|---|---|---|---|
|
Incidence of Unsolicited Adverse Events Within 84 Days
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 180Population: 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.
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.
Outcome measures
| Measure |
PMV Puffhaler®
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
|
PMV SoloventTM
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
|
Subcutaneous Meales Vaccine
n=20 Participants
Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
|
|---|---|---|---|
|
Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day -7, Day 28 and Day 84Population: 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.
The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 was assessed.
Outcome measures
| Measure |
PMV Puffhaler®
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
|
PMV SoloventTM
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
|
Subcutaneous Meales Vaccine
n=20 Participants
Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
|
|---|---|---|---|
|
The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Day -7, Day 28 and Day 84Population: 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.
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.
Outcome measures
| Measure |
PMV Puffhaler®
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
|
PMV SoloventTM
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
|
Subcutaneous Meales Vaccine
n=20 Participants
Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
|
|---|---|---|---|
|
The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre
|
100 percentage of participants
|
100 percentage of participants
|
95 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28 and Day 84Population: 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.
The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed.
Outcome measures
| Measure |
PMV Puffhaler®
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
|
PMV SoloventTM
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
|
Subcutaneous Meales Vaccine
n=20 Participants
Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
|
|---|---|---|---|
|
The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG
at day 28
|
45 percentage of participants
|
20 percentage of participants
|
25 percentage of participants
|
|
The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG
at day 84
|
55 percentage of participants
|
45 percentage of participants
|
35 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28 and Day 84Population: 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.
The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed.
Outcome measures
| Measure |
PMV Puffhaler®
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
|
PMV SoloventTM
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
|
Subcutaneous Meales Vaccine
n=20 Participants
Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
|
|---|---|---|---|
|
The Proportion of Subjects in Each Group With Seroconversion for PRNT
Day 28
|
45 percentage of participants
|
25 percentage of participants
|
30 percentage of participants
|
|
The Proportion of Subjects in Each Group With Seroconversion for PRNT
Day 84
|
30 percentage of participants
|
30 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: Day -7, Day 28 and Day 84Population: 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.
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.
Outcome measures
| Measure |
PMV Puffhaler®
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
|
PMV SoloventTM
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
|
Subcutaneous Meales Vaccine
n=20 Participants
Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies
Baseline (Day-7)
|
0.91 IU/ml
Interval 0.63 to 1.33
|
1.31 IU/ml
Interval 0.93 to 1.84
|
0.86 IU/ml
Interval 0.57 to 1.32
|
|
Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies
Day 28
|
1.46 IU/ml
Interval 1.06 to 2.01
|
1.49 IU/ml
Interval 1.13 to 1.96
|
1.03 IU/ml
Interval 0.86 to 1.23
|
|
Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies
Day 84
|
1.71 IU/ml
Interval 1.31 to 2.22
|
2.14 IU/ml
Interval 1.72 to 2.68
|
1.45 IU/ml
Interval 1.07 to 1.95
|
SECONDARY outcome
Timeframe: Day -7, Day 28 and Day 84Population: 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.
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.
Outcome measures
| Measure |
PMV Puffhaler®
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
|
PMV SoloventTM
n=20 Participants
Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
|
Subcutaneous Meales Vaccine
n=20 Participants
Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
|
|---|---|---|---|
|
Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84
Day 28
|
2626.5 IU/ml
Interval 1719.7 to 4011.4
|
1569.1 IU/ml
Interval 937.44 to 2626.4
|
1789.7 IU/ml
Interval 1047.8 to 3057.0
|
|
Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84
Day 84
|
1789.5 IU/ml
Interval 966.32 to 3313.9
|
1526.5 IU/ml
Interval 824.95 to 2824.8
|
1152.2 IU/ml
Interval 669.71 to 1982.2
|
|
Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84
Baseline (Day -7)
|
1914.3 IU/ml
Interval 826.95 to 4431.6
|
1479.5 IU/ml
Interval 768.41 to 2848.6
|
2010.4 IU/ml
Interval 1033.6 to 3910.5
|
Adverse Events
Dry Powdered Measles Vaccine Via a Puffhaler® Device
Dry Powdered Measles Vaccine Via SoloventTM Device
Licensed Subcutaneous Measles Vaccine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place