Trial Outcomes & Findings for Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V (NCT NCT01229397)
NCT ID: NCT01229397
Last Updated: 2014-02-06
Results Overview
Seroprotection rate
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
205 participants
Primary outcome timeframe
This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Results posted on
2014-02-06
Participant Flow
Recruitment period: 05 October - 17 January 2011; Location: University of Milan
Participant milestones
| Measure |
Inflexal V 0.25 mL x 2
2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 mL dose:
* 7.5 μg HA antigen of A/California/7/2009 (H1N1)-like virus
* 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus
* 7.5 μg HA antigen of B/Brisbane/60/2008-like virus
|
Inflexal V 0.5 mL x 1
1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 mL dose:
* 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus
* 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus
* 15 μg HA antigen of B/Brisbane/60/2008-like virus
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
102
|
|
Overall Study
COMPLETED
|
92
|
93
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
| Measure |
Inflexal V 0.25 mL x 2
2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 mL dose:
* 7.5 μg HA antigen of A/California/7/2009 (H1N1)-like virus
* 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus
* 7.5 μg HA antigen of B/Brisbane/60/2008-like virus
|
Inflexal V 0.5 mL x 1
1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 mL dose:
* 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus
* 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus
* 15 μg HA antigen of B/Brisbane/60/2008-like virus
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
|
Overall Study
Migrated/moved from study area
|
1
|
0
|
Baseline Characteristics
Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V
Baseline characteristics by cohort
| Measure |
Inflexal V 0.25 mL x 2
n=103 Participants
Two 0.25 mL doses (on Day 1 and 29)
|
Inflexal V 0.5 mL x 1
n=102 Participants
One 0.5 mL dose (on Day 1)
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
103 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
1.8 years
STANDARD_DEVIATION 0.52 • n=5 Participants
|
1.8 years
STANDARD_DEVIATION 0.61 • n=7 Participants
|
1.8 years
STANDARD_DEVIATION 0.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
103 participants
n=5 Participants
|
102 participants
n=7 Participants
|
205 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimenPopulation: Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers
Seroprotection rate
Outcome measures
| Measure |
Inflexal V 0.25 mL x 2
n=98 Participants
Two 0.25 mL doses (on Day 1 and 29)
|
Inflexal V 0.5 mL x 1
n=99 Participants
One 0.5 mL dose (on Day 1)
|
Inflexal V 0.5 mL x 1
|
|---|---|---|---|
|
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Percentage of subjects seroprotected: A/H1N1
|
99.0 percentage subjects
Interval 94.4 to 100.0
|
98.0 percentage subjects
Interval 92.9 to 99.8
|
—
|
|
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Percentage of subjects seroprotected: A/H3N2
|
99.0 percentage subjects
Interval 94.4 to 100.0
|
97.0 percentage subjects
Interval 91.4 to 99.4
|
—
|
|
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Percentage of subjects seroprotected: B-strain
|
92.2 percentage subjects
Interval 85.8 to 97.1
|
86.9 percentage subjects
Interval 78.6 to 92.8
|
—
|
PRIMARY outcome
Timeframe: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimenPopulation: Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers
Seroconversion rate
Outcome measures
| Measure |
Inflexal V 0.25 mL x 2
n=98 Participants
Two 0.25 mL doses (on Day 1 and 29)
|
Inflexal V 0.5 mL x 1
n=99 Participants
One 0.5 mL dose (on Day 1)
|
Inflexal V 0.5 mL x 1
|
|---|---|---|---|
|
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Percentage of subjects seroconverted: A/H1N1
|
92.9 percentage subjects
Interval 85.1 to 97.3
|
95.5 percentage subjects
Interval 88.8 to 98.7
|
—
|
|
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Percentage of subjects seroconverted: A/H3N2
|
99.0 percentage subjects
Interval 94.4 to 100.0
|
97.0 percentage subjects
Interval 91.4 to 99.4
|
—
|
|
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Percentage of subjects seroconverted: B-strain
|
92.9 percentage subjects
Interval 85.8 to 97.1
|
86.9 percentage subjects
Interval 78.6 to 92.8
|
—
|
PRIMARY outcome
Timeframe: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimenPopulation: Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Outcome measures
| Measure |
Inflexal V 0.25 mL x 2
n=98 Participants
Two 0.25 mL doses (on Day 1 and 29)
|
Inflexal V 0.5 mL x 1
n=99 Participants
One 0.5 mL dose (on Day 1)
|
Inflexal V 0.5 mL x 1
|
|---|---|---|---|
|
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
GMT fold increase from baseline: A/H1N1
|
25.5 Fold (ratio)
Interval 21.3 to 30.5
|
19.6 Fold (ratio)
Interval 16.9 to 22.7
|
—
|
|
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
GMT fold increase from baseline: A/H3N2
|
31.6 Fold (ratio)
Interval 26.7 to 37.3
|
24.6 Fold (ratio)
Interval 20.7 to 29.3
|
—
|
|
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
GMT fold increase from baseline: B-strain
|
12.8 Fold (ratio)
Interval 11.2 to 14.6
|
14.7 Fold (ratio)
Interval 12.3 to 17.4
|
—
|
SECONDARY outcome
Timeframe: Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diaryPopulation: Safety population, all vaccinated subjects
Outcome measures
| Measure |
Inflexal V 0.25 mL x 2
n=102 Participants
Two 0.25 mL doses (on Day 1 and 29)
|
Inflexal V 0.5 mL x 1
n=101 Participants
One 0.5 mL dose (on Day 1)
|
Inflexal V 0.5 mL x 1
n=100 Participants
|
|---|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability
AEs (unsolicited and solicited)
|
51 participants
|
48 participants
|
49 participants
|
|
Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability
Unsolicited AEs
|
29 participants
|
32 participants
|
30 participants
|
|
Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability
Solicited local AEs
|
22 participants
|
16 participants
|
17 participants
|
|
Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability
Solicited systemic AEs
|
16 participants
|
16 participants
|
20 participants
|
Adverse Events
Inflexal V 0.25 mL x 2 - After 1st Vaccination
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
Inflexal V 0.25 mL x 2 - After 2nd Vaccination
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Inflexal V 0.5 mL x 1
Serious events: 5 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inflexal V 0.25 mL x 2 - After 1st Vaccination
n=102 participants at risk
|
Inflexal V 0.25 mL x 2 - After 2nd Vaccination
n=101 participants at risk
|
Inflexal V 0.5 mL x 1
n=100 participants at risk
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.98%
1/102 • Number of events 1 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
0.00%
0/101 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
1.0%
1/100 • Number of events 1 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/102 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
0.00%
0/101 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
1.0%
1/100 • Number of events 1 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/102 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
0.00%
0/101 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
1.0%
1/100 • Number of events 1 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary Disease
|
0.00%
0/102 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
0.00%
0/101 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
1.0%
1/100 • Number of events 1 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
|
Infections and infestations
Gastroenterisits rotavirus
|
0.00%
0/102 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
0.00%
0/101 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
1.0%
1/100 • Number of events 1 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
Other adverse events
| Measure |
Inflexal V 0.25 mL x 2 - After 1st Vaccination
n=102 participants at risk
|
Inflexal V 0.25 mL x 2 - After 2nd Vaccination
n=101 participants at risk
|
Inflexal V 0.5 mL x 1
n=100 participants at risk
|
|---|---|---|---|
|
General disorders
Pyrexia
|
10.8%
11/102 • Number of events 11 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
9.9%
10/101 • Number of events 13 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
9.0%
9/100 • Number of events 9 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
|
General disorders
Erythema (at the injection site)
|
14.7%
15/102 • Number of events 15 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
6.9%
7/101 • Number of events 7 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
10.0%
10/100 • Number of events 10 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
|
General disorders
Induration (at the injection site)
|
6.9%
7/102 • Number of events 7 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
2.0%
2/101 • Number of events 2 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
6.0%
6/100 • Number of events 6 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
|
General disorders
Pain (at the injection site)
|
10.8%
11/102 • Number of events 11 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
9.9%
10/101 • Number of events 10 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
9.0%
9/100 • Number of events 9 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
|
General disorders
Haemorrhage (at the injection site)
|
2.9%
3/102 • Number of events 3 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
4.0%
4/101 • Number of events 4 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
5.0%
5/100 • Number of events 5 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
|
General disorders
Malaise
|
8.8%
9/102 • Number of events 9 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
7.9%
8/101 • Number of events 8 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
7.0%
7/100 • Number of events 7 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
|
Infections and infestations
Otitis media acute
|
3.9%
4/102 • Number of events 4 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
3.0%
3/101 • Number of events 3 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
5.0%
5/100 • Number of events 5 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
|
Infections and infestations
Rhinitis
|
0.98%
1/102 • Number of events 1 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
8.9%
9/101 • Number of events 10 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
2.0%
2/100 • Number of events 2 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/102 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
7.9%
8/101 • Number of events 8 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
3.0%
3/100 • Number of events 3 • Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 60 days from the time submitted to the sponsor for review. The sponsor reserves the right to remove any proprietary or confidential information and to require that publication be delayed for up to 60 additional days to enable the sponsor to prepare and file patent applications.
- Publication restrictions are in place
Restriction type: OTHER