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Trial Outcomes & Findings for Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains (NCT NCT01631110)

NCT ID: NCT01631110

Last Updated: 2013-12-20

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

110 participants

Primary outcome timeframe

Day 22 +/- 2 days

Results posted on

2013-12-20

Participant Flow

Recruitment period: 23 July 2012 to 14 August 2012; outpatient study

Participant milestones

Participant milestones
Measure
Elderly Subjects Aged Over 60 Years
Adults From 18 to 60 Years Old Inclusive
Overall Study
STARTED
55
55
Overall Study
COMPLETED
55
55
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Elderly Subjects Aged Over 60 Years
n=55 Participants
Adults From 18 to 60 Years Old Inclusive
n=55 Participants
Total
n=110 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
Age, Categorical
Between 18 and 65 years
23 Participants
n=5 Participants
55 Participants
n=7 Participants
78 Participants
n=5 Participants
Age, Categorical
>=65 years
32 Participants
n=5 Participants
0 Participants
n=7 Participants
32 Participants
n=5 Participants
Age, Continuous
67.3 years
STANDARD_DEVIATION 6.01 • n=5 Participants
38.3 years
STANDARD_DEVIATION 11.69 • n=7 Participants
52.8 years
STANDARD_DEVIATION 17.26 • n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
24 Participants
n=7 Participants
46 Participants
n=5 Participants
Sex: Female, Male
Male
33 Participants
n=5 Participants
31 Participants
n=7 Participants
64 Participants
n=5 Participants
Region of Enrollment
Switzerland
55 participants
n=5 Participants
55 participants
n=7 Participants
110 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures
Measure
Elderly Subjects Aged Over 60 Years
n=55 Participants
Adults From 18 to 60 Years Old Inclusive
n=55 Participants
Seroprotection
Percentage seroprotected subjects: A/H1N1
65.5 percentage of subjects
Interval 51.4 to 77.8
80.0 percentage of subjects
Interval 67.0 to 89.6
Seroprotection
Percentage seroprotected subjects: A/H3N2
98.2 percentage of subjects
Interval 90.3 to 100.0
98.2 percentage of subjects
Interval 90.3 to 100.0
Seroprotection
Percentage seroprotected subjects: B strain
52.7 percentage of subjects
Interval 38.8 to 66.3
70.9 percentage of subjects
Interval 57.1 to 82.4

PRIMARY outcome

Timeframe: 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

Outcome measures
Measure
Elderly Subjects Aged Over 60 Years
n=55 Participants
Adults From 18 to 60 Years Old Inclusive
n=55 Participants
Seroconversion
Percentage seroconverted subjects: A/H1N1
50.9 percentage of subjects
Interval 37.1 to 64.6
45.5 percentage of subjects
Interval 32.0 to 59.4
Seroconversion
Percentage seroconverted subjects: A/H3N2
18.2 percentage of subjects
Interval 9.1 to 30.9
12.7 percentage of subjects
Interval 5.3 to 24.5
Seroconversion
Percentage seroconverted subjects: B strain
25.5 percentage of subjects
Interval 14.7 to 39.0
41.8 percentage of subjects
Interval 28.7 to 55.9

PRIMARY outcome

Timeframe: 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

Outcome measures
Measure
Elderly Subjects Aged Over 60 Years
n=55 Participants
Adults From 18 to 60 Years Old Inclusive
n=55 Participants
Geometric Mean Titer
GMT fold increase: A/H1N1
5.15 GMT fold increase from baseline
Interval 3.55 to 7.45
4.36 GMT fold increase from baseline
Interval 3.32 to 5.71
Geometric Mean Titer
GMT fold increase: A/H3N2
1.96 GMT fold increase from baseline
Interval 1.64 to 2.35
1.72 GMT fold increase from baseline
Interval 1.49 to 1.99
Geometric Mean Titer
GMT fold increase: B strain
2.40 GMT fold increase from baseline
Interval 1.97 to 2.92
3.33 GMT fold increase from baseline
Interval 2.55 to 4.36

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 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

Outcome measures
Measure
Elderly Subjects Aged Over 60 Years
n=55 Participants
Adults From 18 to 60 Years Old Inclusive
n=55 Participants
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
AEs (unsolicited and unsolicited)
25 Participants
35 Participants
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
Unsolicited AEs
10 Participants
10 Participants
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
Solicited local AEs
17 Participants
33 Participants
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
Solicited systemic AEs
3 Participants
2 Participants

Adverse Events

Elderly Subjects Aged Over 60 Years

Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths

Adults From 18 to 60 Years Old Inclusive

Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Elderly Subjects Aged Over 60 Years
n=55 participants at risk
Adults From 18 to 60 Years Old Inclusive
n=55 participants at risk
Ear and labyrinth disorders
Ear pain
0.00%
0/55
1.8%
1/55 • Number of events 1
Gastrointestinal disorders
Diarrhea
1.8%
1/55 • Number of events 1
0.00%
0/55
General disorders
Chills
1.8%
1/55 • Number of events 1
0.00%
0/55
General disorders
Fatigue
3.6%
2/55 • Number of events 2
0.00%
0/55
General disorders
Injection site pruritus
0.00%
0/55
1.8%
1/55 • Number of events 1
General disorders
Vessel puncture swelling
1.8%
1/55 • Number of events 1
0.00%
0/55
General disorders
Injection site erythema
10.9%
6/55 • Number of events 6
12.7%
7/55 • Number of events 7
General disorders
Injection site haemorrhage
3.6%
2/55 • Number of events 2
7.3%
4/55 • Number of events 4
General disorders
Injection site induration
5.5%
3/55 • Number of events 3
10.9%
6/55 • Number of events 6
General disorders
Injection site pain
18.2%
10/55 • Number of events 10
49.1%
27/55 • Number of events 27
General disorders
Malaise
3.6%
2/55 • Number of events 2
3.6%
2/55 • Number of events 2
Infections and infestations
Oral herpes
1.8%
1/55 • Number of events 1
0.00%
0/55
Metabolism and nutrition disorders
Diabetes mellitus
1.8%
1/55 • Number of events 1
0.00%
0/55
Musculoskeletal and connective tissue disorders
Arthralgia
1.8%
1/55 • Number of events 3
0.00%
0/55
Musculoskeletal and connective tissue disorders
Back pain
1.8%
1/55 • Number of events 1
0.00%
0/55
Musculoskeletal and connective tissue disorders
Myalgia
1.8%
1/55 • Number of events 1
1.8%
1/55 • Number of events 1
Nervous system disorders
Headache
3.6%
2/55 • Number of events 2
12.7%
7/55 • Number of events 7
Nervous system disorders
Migraine
1.8%
1/55 • Number of events 1
0.00%
0/55
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/55
1.8%
1/55 • Number of events 1

Additional Information

Medical Affairs Director

Crucell Switzerland AG

Phone: +41(0)319806111

Results disclosure agreements

  • Principal investigator is a sponsor employee Material for public dissemination will be submitted to the sponsor for review at least ninety (90) days prior to submission for publication, public dissemination, or review by a publication committee.
  • Publication restrictions are in place

Restriction type: OTHER