Trial Outcomes & Findings for Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers (NCT NCT01229371)
NCT ID: NCT01229371
Last Updated: 2013-09-09
Results Overview
The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT
COMPLETED
PHASE3
440 participants
3 weeks after vaccination (Day 22 ± 2 days)
2013-09-09
Participant Flow
Recruitment period: 19 October 2010 to 09 November 2010; outpatient study
Participant milestones
| Measure |
Subjects ≥18 to ≤60 Years - AdImmune HA Antigen
|
Subjects ≥18 to ≤60 Years - CSL HA Antigen
|
Subjects >60 Years - AdImmune HA Antigen
|
Subjects >60 Years - CSL HA Antigen
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
109
|
111
|
110
|
110
|
|
Overall Study
COMPLETED
|
109
|
110
|
110
|
110
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Subjects ≥18 to ≤60 Years - AdImmune HA Antigen
|
Subjects ≥18 to ≤60 Years - CSL HA Antigen
|
Subjects >60 Years - AdImmune HA Antigen
|
Subjects >60 Years - CSL HA Antigen
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers
Baseline characteristics by cohort
| Measure |
Subjects ≥18 to ≤60 Years - AdImmune HA Antigen
n=109 Participants
|
Subjects ≥18 to ≤60 Years - CSL HA Antigen
n=111 Participants
|
Subjects >60 Years - AdImmune HA Antigen
n=110 Participants
|
Subjects >60 Years - CSL HA Antigen
n=110 Participants
|
Total
n=440 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
109 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
320 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Age Continuous
|
39.5 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 12.10 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 5.50 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 5.06 • n=4 Participants
|
53.1 years
STANDARD_DEVIATION 16.14 • n=21 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
206 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
234 Participants
n=21 Participants
|
|
Region of Enrollment
Switzerland
|
109 participants
n=5 Participants
|
111 participants
n=7 Participants
|
110 participants
n=5 Participants
|
110 participants
n=4 Participants
|
440 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 weeks after vaccination (Day 22 ± 2 days)Population: Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers
The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT
Outcome measures
| Measure |
Subjects ≥18 to ≤60 Years - AdImmune HA Antigen
n=109 Participants
|
Subjects ≥18 to ≤60 Years - CSL HA Antigen
n=110 Participants
|
Subjects >60 Years - AdImmune HA Antigen
n=110 Participants
|
Subjects >60 Years - CSL HA Antigen
n=110 Participants
|
|---|---|---|---|---|
|
Immunogenicity - Geometric Mean Titer Fold Increase From Baseline
GMT fold increase from baseline: A/H1N1
|
3.5 GMT fold increase
Interval 2.8 to 4.3
|
4.0 GMT fold increase
Interval 3.3 to 5.0
|
4.5 GMT fold increase
Interval 3.6 to 5.7
|
3.4 GMT fold increase
Interval 2.8 to 4.2
|
|
Immunogenicity - Geometric Mean Titer Fold Increase From Baseline
GMT fold increase from baseline: A/H3N2
|
2.5 GMT fold increase
Interval 2.1 to 3.0
|
2.5 GMT fold increase
Interval 2.1 to 2.9
|
2.2 GMT fold increase
Interval 1.8 to 2.6
|
1.9 GMT fold increase
Interval 1.5 to 2.3
|
|
Immunogenicity - Geometric Mean Titer Fold Increase From Baseline
GMT fold increase from baseline: B-strain
|
3.2 GMT fold increase
Interval 2.6 to 3.8
|
3.1 GMT fold increase
Interval 2.6 to 3.7
|
1.9 GMT fold increase
Interval 1.7 to 2.2
|
2.1 GMT fold increase
Interval 1.8 to 2.4
|
PRIMARY outcome
Timeframe: 3 weeks after vaccination (Day 22 ± 2 days)Population: Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers
The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT
Outcome measures
| Measure |
Subjects ≥18 to ≤60 Years - AdImmune HA Antigen
n=109 Participants
|
Subjects ≥18 to ≤60 Years - CSL HA Antigen
n=110 Participants
|
Subjects >60 Years - AdImmune HA Antigen
n=110 Participants
|
Subjects >60 Years - CSL HA Antigen
n=110 Participants
|
|---|---|---|---|---|
|
Immunogenicity - Seroprotection Rate
Percentage of subjects seroprotected: A/H1N1
|
99.1 percentage subjects
Interval 95.0 to 100.0
|
98.2 percentage subjects
Interval 93.6 to 99.8
|
92.7 percentage subjects
Interval 82.8 to 96.8
|
90.0 percentage subjects
Interval 82.8 to 94.9
|
|
Immunogenicity - Seroprotection Rate
Percentage of subjects seroprotected: A/H3N2
|
99.1 percentage subjects
Interval 95.0 to 100.0
|
99.1 percentage subjects
Interval 95.0 to 100.0
|
100 percentage subjects
Interval 96.7 to 100.0
|
99.1 percentage subjects
Interval 95.0 to 100.0
|
|
Immunogenicity - Seroprotection Rate
Percentage of subjects seroprotected: B-strain
|
96.3 percentage subjects
Interval 90.9 to 99.0
|
97.3 percentage subjects
Interval 92.2 to 99.4
|
85.5 percentage subjects
Interval 77.5 to 91.5
|
86.4 percentage subjects
Interval 78.5 to 92.2
|
PRIMARY outcome
Timeframe: 3 weeks after vaccination (Day 22 ± 2 days)Population: Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers
The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT
Outcome measures
| Measure |
Subjects ≥18 to ≤60 Years - AdImmune HA Antigen
n=109 Participants
|
Subjects ≥18 to ≤60 Years - CSL HA Antigen
n=110 Participants
|
Subjects >60 Years - AdImmune HA Antigen
n=110 Participants
|
Subjects >60 Years - CSL HA Antigen
n=110 Participants
|
|---|---|---|---|---|
|
Immunogenicity - Seroconversion Rate
Percentage of subjects seroprotected: A/H1N1
|
45.0 percentage subjects
Interval 35.4 to 54.8
|
52.7 percentage subjects
Interval 43.0 to 62.3
|
54.5 percentage subjects
Interval 44.8 to 64.1
|
43.6 percentage subjects
Interval 34.2 to 53.4
|
|
Immunogenicity - Seroconversion Rate
Percentage of subjects seroprotected: A/H3N2
|
27.5 percentage subjects
Interval 19.4 to 36.9
|
29.1 percentage subjects
Interval 20.8 to 38.5
|
25.5 percentage subjects
Interval 17.6 to 34.6
|
17.3 percentage subjects
Interval 10.7 to 25.7
|
|
Immunogenicity - Seroconversion Rate
Percentage of subjects seroprotected: B-strain
|
40.4 percentage subjects
Interval 31.1 to 50.2
|
44.5 percentage subjects
Interval 35.1 to 54.3
|
20.9 percentage subjects
Interval 13.7 to 29.7
|
20.0 percentage subjects
Interval 13.0 to 28.7
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)Population: Safety population, all vaccinated subjects
Solicited local and systemic AEs, Unsolicited AEs, Tolerability and acceptability Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days). Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4
Outcome measures
| Measure |
Subjects ≥18 to ≤60 Years - AdImmune HA Antigen
n=109 Participants
|
Subjects ≥18 to ≤60 Years - CSL HA Antigen
n=111 Participants
|
Subjects >60 Years - AdImmune HA Antigen
n=110 Participants
|
Subjects >60 Years - CSL HA Antigen
n=110 Participants
|
|---|---|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events
Unsolicited AEs
|
14 participants
|
21 participants
|
8 participants
|
11 participants
|
|
Number of Participants With Local and Systemic Adverse Events
AEs (unsolicited and solicited)
|
57 participants
|
58 participants
|
25 participants
|
30 participants
|
|
Number of Participants With Local and Systemic Adverse Events
Solicited local AEs
|
45 participants
|
41 participants
|
18 participants
|
21 participants
|
|
Number of Participants With Local and Systemic Adverse Events
Solicited systemic AEs
|
14 participants
|
9 participants
|
6 participants
|
4 participants
|
Adverse Events
Subjects ≥18 to ≤60 Years - AdImmune HA Antigen
Subjects ≥18 to ≤60 Years - CSL HA Antigen
Subjects >60 Years - AdImmune HA Antigen
Subjects >60 Years - CSL HA Antigen
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects ≥18 to ≤60 Years - AdImmune HA Antigen
n=109 participants at risk
|
Subjects ≥18 to ≤60 Years - CSL HA Antigen
n=111 participants at risk
|
Subjects >60 Years - AdImmune HA Antigen
n=110 participants at risk
|
Subjects >60 Years - CSL HA Antigen
n=110 participants at risk
|
|---|---|---|---|---|
|
General disorders
Chills
|
6.4%
7/109 • Number of events 7
|
2.7%
3/111 • Number of events 3
|
3.6%
4/110 • Number of events 4
|
0.91%
1/110 • Number of events 1
|
|
General disorders
Fatigue
|
2.8%
3/109 • Number of events 3
|
1.8%
2/111 • Number of events 2
|
0.00%
0/110
|
0.91%
1/110 • Number of events 1
|
|
General disorders
Haemorrhage (at the injection site)
|
0.92%
1/109 • Number of events 1
|
3.6%
4/111 • Number of events 4
|
0.00%
0/110
|
0.91%
1/110 • Number of events 1
|
|
General disorders
Erythema (at the injection site)
|
6.4%
7/109 • Number of events 7
|
5.4%
6/111 • Number of events 6
|
8.2%
9/110 • Number of events 9
|
4.5%
5/110 • Number of events 5
|
|
General disorders
Induration (at the injection site)
|
10.1%
11/109 • Number of events 11
|
7.2%
8/111 • Number of events 8
|
8.2%
9/110 • Number of events 9
|
4.5%
5/110 • Number of events 5
|
|
General disorders
Pain (at the injection site)
|
34.9%
38/109 • Number of events 38
|
35.1%
39/111 • Number of events 39
|
12.7%
14/110 • Number of events 14
|
12.7%
14/110 • Number of events 14
|
|
General disorders
Malaise
|
11.0%
12/109 • Number of events 13
|
3.6%
4/111 • Number of events 4
|
5.5%
6/110 • Number of events 6
|
2.7%
3/110 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
0.92%
1/109 • Number of events 1
|
1.8%
2/111 • Number of events 2
|
0.91%
1/110 • Number of events 1
|
1.8%
2/110 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.92%
1/109 • Number of events 1
|
2.7%
3/111 • Number of events 3
|
1.8%
2/110 • Number of events 2
|
0.00%
0/110
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only 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 between 30 to 90 days (depending on the complexitiy of the work) from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER