Influenza
Conditions
Keywords
Influenza, Virus, Vaccination, Immunisation
Brief summary
A study to assess whether the Northern Hemisphere 2010/2011 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines
Interventions
BIOLOGICALInflexal V
Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2010-2011 season, containing per 0.5 mL dose: * 15 µg hemagglutinin (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 Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1
Sponsors
Crucell Holland BV
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy female and male adults * Aged ≥18 to ≤60 years or \>60 years on Day 1 * Written informed consent
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, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed) * Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity) * 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 or spouse of the investigator * Suspected non-compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion | Day 22 ± 2 days | Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40 |
| Seroprotection | Day 22 ± 2 days | Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40 |
| Fold Increase in Geometric Mean Titer (GMT) | Day 22/Day 1 | GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Numbers of Subjects Reporting Solicited Local Adverse Events | Days 1 to 4 inclusive, and Days 8, 15 and 22 | Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination. |
| Numbers of Subjects Reporting Solicited Systemic Adverse Events | Days 1 to 4 inclusive, and Days 8, 15 and 22 | Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination. |
Countries
Switzerland
Participant flow
Recruitment details
Participants were recruited at one center in Switzerland First subject first visit (FSFV): 28-Jun-2010 Last subject last visit (LSLV): 20-Jul-2010
Participants by arm
| Arm | Count |
|---|---|
| Adults Adults from 18 to 60 years old inclusive | 55 |
| Elderly Elderly subjects aged over 60 years | 55 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrew consent | 1 | 0 |
Baseline characteristics
| Characteristic | Adults | Elderly | Total |
|---|---|---|---|
| Age Continuous | 43.0 years STANDARD_DEVIATION 11.9 | 69.8 years STANDARD_DEVIATION 5.7 | 56.4 years STANDARD_DEVIATION 16.4 |
| Sex: Female, Male Female | 29 Participants | 28 Participants | 57 Participants |
| Sex: Female, Male Male | 26 Participants | 27 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 55 | 26 / 55 |
| serious Total, serious adverse events | 0 / 55 | 1 / 55 |
Outcome results
Primary
Fold Increase in Geometric Mean Titer (GMT)
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Time frame: Day 22/Day 1
Population: ITT/ATP
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults | Fold Increase in Geometric Mean Titer (GMT) | A/California/7/2009 | 25.9 Fold (ratio) |
| Adults | Fold Increase in Geometric Mean Titer (GMT) | A/Perth/16/2009 | 10.6 Fold (ratio) |
| Adults | Fold Increase in Geometric Mean Titer (GMT) | B/Brisbane/60/2008 | 6.1 Fold (ratio) |
| Elderly | Fold Increase in Geometric Mean Titer (GMT) | A/California/7/2009 | 30.8 Fold (ratio) |
| Elderly | Fold Increase in Geometric Mean Titer (GMT) | A/Perth/16/2009 | 14.0 Fold (ratio) |
| Elderly | Fold Increase in Geometric Mean Titer (GMT) | B/Brisbane/60/2008 | 5.7 Fold (ratio) |
Primary
Seroconversion
Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40
Time frame: Day 22 ± 2 days
Population: Intention-to-treat (ITT) and According-to-protocol (ATP) populations excludes one subject lost to follow up and one subject who withdrew consent
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults | Seroconversion | A/California/7/2009 | 43 Number of subjects |
| Adults | Seroconversion | A/Perth/16/2009 | 45 Number of subjects |
| Adults | Seroconversion | B/Brisbane/60/2008 | 27 Number of subjects |
| Elderly | Seroconversion | A/California/7/2009 | 50 Number of subjects |
| Elderly | Seroconversion | A/Perth/16/2009 | 48 Number of subjects |
| Elderly | Seroconversion | B/Brisbane/60/2008 | 33 Number of subjects |
Primary
Seroprotection
Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40
Time frame: Day 22 ± 2 days
Population: ITT/ATP
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults | Seroprotection | A/California/7/2009 | 45 Number of subjects |
| Adults | Seroprotection | A/Perth/16/2009 | 52 Number of subjects |
| Adults | Seroprotection | B/Brisbane/60/2008 | 50 Number of subjects |
| Elderly | Seroprotection | A/California/7/2009 | 51 Number of subjects |
| Elderly | Seroprotection | A/Perth/16/2009 | 55 Number of subjects |
| Elderly | Seroprotection | B/Brisbane/60/2008 | 51 Number of subjects |
Secondary
Numbers of Subjects Reporting Solicited Systemic Adverse Events
Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Time frame: Days 1 to 4 inclusive, and Days 8, 15 and 22
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults | Numbers of Subjects Reporting Solicited Systemic Adverse Events | Shivering | 0 Subjects |
| Adults | Numbers of Subjects Reporting Solicited Systemic Adverse Events | Malaise | 2 Subjects |
| Adults | Numbers of Subjects Reporting Solicited Systemic Adverse Events | Fever | 0 Subjects |
| Elderly | Numbers of Subjects Reporting Solicited Systemic Adverse Events | Shivering | 0 Subjects |
| Elderly | Numbers of Subjects Reporting Solicited Systemic Adverse Events | Malaise | 3 Subjects |
| Elderly | Numbers of Subjects Reporting Solicited Systemic Adverse Events | Fever | 2 Subjects |
Secondary
Safety: Numbers of Subjects Reporting Solicited Local Adverse Events
Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Time frame: Days 1 to 4 inclusive, and Days 8, 15 and 22
Population: Safety population includes all subjects who received study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults | Safety: Numbers of Subjects Reporting Solicited Local Adverse Events | Ecchymosis | 1 Subjects |
| Adults | Safety: Numbers of Subjects Reporting Solicited Local Adverse Events | Erythema | 16 Subjects |
| Adults | Safety: Numbers of Subjects Reporting Solicited Local Adverse Events | Induration | 6 Subjects |
| Adults | Safety: Numbers of Subjects Reporting Solicited Local Adverse Events | Pain | 20 Subjects |
| Elderly | Safety: Numbers of Subjects Reporting Solicited Local Adverse Events | Pain | 9 Subjects |
| Elderly | Safety: Numbers of Subjects Reporting Solicited Local Adverse Events | Ecchymosis | 2 Subjects |
| Elderly | Safety: Numbers of Subjects Reporting Solicited Local Adverse Events | Induration | 6 Subjects |
| Elderly | Safety: Numbers of Subjects Reporting Solicited Local Adverse Events | Erythema | 16 Subjects |