Trial Outcomes & Findings for Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers (NCT NCT01412281)
NCT ID: NCT01412281
Last Updated: 2013-09-09
Results Overview
GMT of HI antibodies and fold-increase in GMT (The primary endpoints are 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)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
440 participants
Primary outcome timeframe
3 weeks after vaccination (Day 22 ± 2 days)
Results posted on
2013-09-09
Participant Flow
Recruitment period: 06 October 2011 to 10 November 2011; outpatient study
Participant milestones
| Measure |
≥18 to ≤60 Years - AdImmune HA Antigen
|
≥18 to ≤60 Years - CSL HA Antigen
|
>60 Years - AdImmune HA Antigen
|
>60 Years - CSL HA Antigen
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
110
|
110
|
110
|
110
|
|
Overall Study
COMPLETED
|
110
|
110
|
110
|
110
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers
Baseline characteristics by cohort
| Measure |
≥18 to ≤60 Years - AdImmune HA Antigen
n=110 Participants
|
≥18 to ≤60 Years - CSL HA Antigen
n=110 Participants
|
>60 Years - AdImmune HA Antigen
n=110 Participants
|
>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
|
110 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
291 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
149 Participants
n=21 Participants
|
|
Age Continuous
|
39.6 years
STANDARD_DEVIATION 12.46 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 11.98 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 5.86 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 5.31 • n=4 Participants
|
54.6 years
STANDARD_DEVIATION 16.56 • n=21 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
207 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
233 Participants
n=21 Participants
|
|
Region of Enrollment
Switzerland
|
110 participants
n=5 Participants
|
110 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, vaccinated subjects with available pre- and post-vaccination titers
GMT of HI antibodies and fold-increase in GMT (The primary endpoints are 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)
Outcome measures
| Measure |
≥18 to ≤60 Years - AdImmune HA Antigen
n=110 Participants
|
≥18 to ≤60 Years - CSL HA Antigen
n=110 Participants
|
>60 Years - AdImmune HA Antigen
n=110 Participants
|
>60 Years - CSL HA Antigen
n=110 Participants
|
|---|---|---|---|---|
|
Geometric Mean Titer
GMT fold increase: A/H1N1
|
3.36 GMT fold increase from baseline
Interval 2.78 to 4.07
|
2.61 GMT fold increase from baseline
Interval 2.21 to 3.09
|
2.46 GMT fold increase from baseline
Interval 2.11 to 2.87
|
2.41 GMT fold increase from baseline
Interval 2.04 to 2.85
|
|
Geometric Mean Titer
GMT fold increase: A/H3N2
|
2.01 GMT fold increase from baseline
Interval 1.67 to 2.41
|
2.04 GMT fold increase from baseline
Interval 1.76 to 2.36
|
1.65 GMT fold increase from baseline
Interval 1.43 to 1.89
|
1.99 GMT fold increase from baseline
Interval 1.7 to 2.33
|
|
Geometric Mean Titer
GMT fold increase: B-strain
|
1.75 GMT fold increase from baseline
Interval 1.54 to 1.99
|
1.72 GMT fold increase from baseline
Interval 1.53 to 1.95
|
1.47 GMT fold increase from baseline
Interval 1.33 to 1.62
|
1.32 GMT fold increase from baseline
Interval 1.21 to 1.44
|
PRIMARY outcome
Timeframe: 3 weeks after vaccination (Day 22 ± 2 days)Population: Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers
Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are 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)
Outcome measures
| Measure |
≥18 to ≤60 Years - AdImmune HA Antigen
n=110 Participants
|
≥18 to ≤60 Years - CSL HA Antigen
n=110 Participants
|
>60 Years - AdImmune HA Antigen
n=110 Participants
|
>60 Years - CSL HA Antigen
n=110 Participants
|
|---|---|---|---|---|
|
Seroprotection
Percentage seroprotected subjects: B-strain
|
98.2 percentage of seroprotected subjects
Interval 93.6 to 99.8
|
100 percentage of seroprotected subjects
Interval 96.7 to 100.0
|
97.3 percentage of seroprotected subjects
Interval 92.2 to 99.4
|
95.5 percentage of seroprotected subjects
Interval 89.7 to 98.5
|
|
Seroprotection
Percentage seroprotected subjects: A/H1N1
|
99.1 percentage of seroprotected subjects
Interval 95.0 to 100.0
|
100 percentage of seroprotected subjects
Interval 96.7 to 100.0
|
96.4 percentage of seroprotected subjects
Interval 91.0 to 99.0
|
97.3 percentage of seroprotected subjects
Interval 92.2 to 99.4
|
|
Seroprotection
Percentage seroprotected subjects: A/H3N2
|
100 percentage of seroprotected subjects
Interval 96.7 to 100.0
|
99.1 percentage of seroprotected subjects
Interval 95.0 to 100.0
|
99.1 percentage of seroprotected subjects
Interval 95.0 to 100.0
|
100 percentage of seroprotected subjects
Interval 96.7 to 100.0
|
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
Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are 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)
Outcome measures
| Measure |
≥18 to ≤60 Years - AdImmune HA Antigen
n=110 Participants
|
≥18 to ≤60 Years - CSL HA Antigen
n=110 Participants
|
>60 Years - AdImmune HA Antigen
n=110 Participants
|
>60 Years - CSL HA Antigen
n=110 Participants
|
|---|---|---|---|---|
|
Seroconversion
Percentage seroconverted subjects: A/H3N2
|
23.6 percentage of seroconverted subjects
Interval 16.1 to 32.7
|
20.0 percentage of seroconverted subjects
Interval 13.0 to 28.7
|
16.4 percentage of seroconverted subjects
Interval 10.0 to 24.6
|
26.4 percentage of seroconverted subjects
Interval 18.4 to 35.6
|
|
Seroconversion
Percentage seroconverted subjects: B-strain
|
19.1 percentage of seroconverted subjects
Interval 12.2 to 27.7
|
17.3 percentage of seroconverted subjects
Interval 10.7 to 25.7
|
8.2 percentage of seroconverted subjects
Interval 3.8 to 15.0
|
4.5 percentage of seroconverted subjects
Interval 1.5 to 10.3
|
|
Seroconversion
Percentage seroconverted subjects: A/H1N1
|
43.6 percentage of seroconverted subjects
Interval 34.2 to 53.4
|
36.4 percentage of seroconverted subjects
Interval 27.4 to 46.1
|
23.6 percentage of seroconverted subjects
Interval 16.1 to 32.7
|
30.9 percentage of seroconverted subjects
Interval 22.4 to 40.4
|
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 |
≥18 to ≤60 Years - AdImmune HA Antigen
n=110 Participants
|
≥18 to ≤60 Years - CSL HA Antigen
n=110 Participants
|
>60 Years - AdImmune HA Antigen
n=110 Participants
|
>60 Years - CSL HA Antigen
n=110 Participants
|
|---|---|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
AEs (unsolicited and unsolicited)
|
60 participants
|
52 participants
|
33 participants
|
29 participants
|
|
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
Solicited local AEs
|
47 participants
|
32 participants
|
20 participants
|
17 participants
|
|
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
Unsolicited AEs
|
30 participants
|
28 participants
|
17 participants
|
14 participants
|
|
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
Solicited systemic AEs
|
8 participants
|
10 participants
|
5 participants
|
3 participants
|
Adverse Events
≥18 to ≤60 Years - AdImmune HA Antigen
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
≥18 to ≤60 Years - CSL HA Antigen
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
>60 Years - AdImmune HA Antigen
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
>60 Years - CSL HA Antigen
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
≥18 to ≤60 Years - AdImmune HA Antigen
n=110 participants at risk
|
≥18 to ≤60 Years - CSL HA Antigen
n=110 participants at risk
|
>60 Years - AdImmune HA Antigen
n=110 participants at risk
|
>60 Years - CSL HA Antigen
n=110 participants at risk
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/110
|
0.00%
0/110
|
0.00%
0/110
|
0.91%
1/110 • Number of events 1
|
Other adverse events
| Measure |
≥18 to ≤60 Years - AdImmune HA Antigen
n=110 participants at risk
|
≥18 to ≤60 Years - CSL HA Antigen
n=110 participants at risk
|
>60 Years - AdImmune HA Antigen
n=110 participants at risk
|
>60 Years - CSL HA Antigen
n=110 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoae
|
0.91%
1/110 • Number of events 1
|
2.7%
3/110 • Number of events 3
|
1.8%
2/110 • Number of events 2
|
0.00%
0/110
|
|
General disorders
Chills
|
2.7%
3/110 • Number of events 3
|
1.8%
2/110 • Number of events 2
|
0.00%
0/110
|
0.00%
0/110
|
|
General disorders
Erythema (at the injection site)
|
10.0%
11/110 • Number of events 11
|
6.4%
7/110 • Number of events 7
|
5.5%
6/110 • Number of events 6
|
8.2%
9/110 • Number of events 9
|
|
General disorders
Induration (at the injection site)
|
5.5%
6/110 • Number of events 6
|
5.5%
6/110 • Number of events 6
|
1.8%
2/110 • Number of events 2
|
3.6%
4/110 • Number of events 4
|
|
General disorders
Pain (at the injection site)
|
40.0%
44/110 • Number of events 44
|
28.2%
31/110 • Number of events 31
|
16.4%
18/110 • Number of events 18
|
10.9%
12/110 • Number of events 12
|
|
General disorders
Malaise
|
5.5%
6/110 • Number of events 6
|
7.3%
8/110 • Number of events 8
|
1.8%
2/110 • Number of events 2
|
0.91%
1/110 • Number of events 1
|
|
General disorders
Pyrexia
|
0.91%
1/110 • Number of events 1
|
1.8%
2/110 • Number of events 2
|
2.7%
3/110 • Number of events 3
|
1.8%
2/110 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
4/110 • Number of events 4
|
3.6%
4/110 • Number of events 4
|
6.4%
7/110 • Number of events 7
|
1.8%
2/110 • Number of events 2
|
|
Infections and infestations
Rhinitis
|
6.4%
7/110 • Number of events 7
|
4.5%
5/110 • Number of events 5
|
0.91%
1/110 • Number of events 1
|
1.8%
2/110 • Number of events 2
|
|
Nervous system disorders
Headache
|
7.3%
8/110 • Number of events 9
|
8.2%
9/110 • Number of events 9
|
1.8%
2/110 • Number of events 2
|
1.8%
2/110 • Number of events 2
|
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 90 days from the time submitted to the sponsor for review. The sponsor can make a reasoned request that publication be delayed for up to 3 months from the date of first submission to the sponsor in order to enable the sponsor to protect proprietary information, Intellectual Property, etc.
- Publication restrictions are in place
Restriction type: OTHER