Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains
Study Details
Study Description
Brief Summary
The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Elderly subjects aged over 60 years
|
Biological: Inflexal V
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
Other Names:
|
| Experimental: Adults from 18 to 60 years old inclusive
|
Biological: Inflexal V
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Seroprotection [Day 22 +/- 2 days]
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)
- Seroconversion [Day 22 +/- 2 days]
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)
- Geometric Mean Titer [Day 22 +/- 2 days]
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)
Secondary Outcome Measures
- Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability [Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy female and male adults aged ≥18 on Day 1
-
Written informed consent
-
Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years
Exclusion Criteria:
-
Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
-
Acute febrile illness (≥38.0 °C)
-
Prior vaccination with an influenza vaccine in the past 330 days
-
Known hypersensitivity to any vaccine component
-
Previous history of a serious adverse reaction to influenza vaccine
-
History of egg protein allergy or severe atopy
-
Known blood coagulation disorder
-
Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
-
Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
-
Investigational medicinal product received in the past 3 months (90 days)
-
Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
-
Pregnancy or lactation
-
Participation in another clinical trial
-
Employee at the investigational site, or relative of the investigator
-
Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Covance Clinical Research Unit AG | Allschwil | Switzerland | 4123 |
Sponsors and Collaborators
- Crucell Holland BV
Investigators
- Principal Investigator: Michael Seiberling, MD, Covance Clinical Research Unit AG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INF-V-A010
Study Results
Participant Flow
| Recruitment Details | Recruitment period: 23 July 2012 to 14 August 2012; outpatient study |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Elderly Subjects Aged Over 60 Years | Adults From 18 to 60 Years Old Inclusive |
|---|---|---|
| Arm/Group Description | ||
| Period Title: Overall Study | ||
| STARTED | 55 | 55 |
| COMPLETED | 55 | 55 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Elderly Subjects Aged Over 60 Years | Adults From 18 to 60 Years Old Inclusive | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Overall Participants | 55 | 55 | 110 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
23
41.8%
|
55
100%
|
78
70.9%
|
| >=65 years |
32
58.2%
|
0
0%
|
32
29.1%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
67.3
(6.01)
|
38.3
(11.69)
|
52.8
(17.26)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
22
40%
|
24
43.6%
|
46
41.8%
|
| Male |
33
60%
|
31
56.4%
|
64
58.2%
|
| Region of Enrollment (participants) [Number] | |||
| Switzerland |
55
100%
|
55
100%
|
110
100%
|
Outcome Measures
| Title | Seroprotection |
|---|---|
| Description | 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) |
| Time Frame | Day 22 +/- 2 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers |
| Arm/Group Title | Elderly Subjects Aged Over 60 Years | Adults From 18 to 60 Years Old Inclusive |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 55 | 55 |
| Percentage seroprotected subjects: A/H1N1 |
65.5
|
80.0
|
| Percentage seroprotected subjects: A/H3N2 |
98.2
|
98.2
|
| Percentage seroprotected subjects: B strain |
52.7
|
70.9
|
| Title | Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability |
|---|---|
| Description | 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 |
| Time Frame | Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population, all vaccinated subjects |
| Arm/Group Title | Elderly Subjects Aged Over 60 Years | Adults From 18 to 60 Years Old Inclusive |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 55 | 55 |
| AEs (unsolicited and unsolicited) |
25
45.5%
|
35
63.6%
|
| Unsolicited AEs |
10
18.2%
|
10
18.2%
|
| Solicited local AEs |
17
30.9%
|
33
60%
|
| Solicited systemic AEs |
3
5.5%
|
2
3.6%
|
| Title | Seroconversion |
|---|---|
| Description | 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) |
| Time Frame | Day 22 +/- 2 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers |
| Arm/Group Title | Elderly Subjects Aged Over 60 Years | Adults From 18 to 60 Years Old Inclusive |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 55 | 55 |
| Percentage seroconverted subjects: A/H1N1 |
50.9
|
45.5
|
| Percentage seroconverted subjects: A/H3N2 |
18.2
|
12.7
|
| Percentage seroconverted subjects: B strain |
25.5
|
41.8
|
| Title | Geometric Mean Titer |
|---|---|
| Description | 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) |
| Time Frame | Day 22 +/- 2 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers |
| Arm/Group Title | Elderly Subjects Aged Over 60 Years | Adults From 18 to 60 Years Old Inclusive |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 55 | 55 |
| GMT fold increase: A/H1N1 |
5.15
|
4.36
|
| GMT fold increase: A/H3N2 |
1.96
|
1.72
|
| GMT fold increase: B strain |
2.40
|
3.33
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Elderly Subjects Aged Over 60 Years | Adults From 18 to 60 Years Old Inclusive | ||
| Arm/Group Description | ||||
All Cause Mortality |
||||
| Elderly Subjects Aged Over 60 Years | Adults From 18 to 60 Years Old Inclusive | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Elderly Subjects Aged Over 60 Years | Adults From 18 to 60 Years Old Inclusive | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | 0/55 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Elderly Subjects Aged Over 60 Years | Adults From 18 to 60 Years Old Inclusive | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 25/55 (45.5%) | 35/55 (63.6%) | ||
| Ear and labyrinth disorders | ||||
| Ear pain | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Gastrointestinal disorders | ||||
| Diarrhea | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| General disorders | ||||
| Chills | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Fatigue | 2/55 (3.6%) | 2 | 0/55 (0%) | 0 |
| Injection site pruritus | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Vessel puncture swelling | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Injection site erythema | 6/55 (10.9%) | 6 | 7/55 (12.7%) | 7 |
| Injection site haemorrhage | 2/55 (3.6%) | 2 | 4/55 (7.3%) | 4 |
| Injection site induration | 3/55 (5.5%) | 3 | 6/55 (10.9%) | 6 |
| Injection site pain | 10/55 (18.2%) | 10 | 27/55 (49.1%) | 27 |
| Malaise | 2/55 (3.6%) | 2 | 2/55 (3.6%) | 2 |
| Infections and infestations | ||||
| Oral herpes | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/55 (1.8%) | 3 | 0/55 (0%) | 0 |
| Back pain | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Myalgia | 1/55 (1.8%) | 1 | 1/55 (1.8%) | 1 |
| Nervous system disorders | ||||
| Headache | 2/55 (3.6%) | 2 | 7/55 (12.7%) | 7 |
| Migraine | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Oropharyngeal pain | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Medical Affairs Director |
|---|---|
| Organization | Crucell Switzerland AG |
| Phone | +41(0)319806111 |
| info@crucell.com |
- INF-V-A010