A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere
This study has been completed.
Sponsor:
Crucell Holland BV
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01303510
First received: February 23, 2011
Last updated: November 15, 2011
Last verified: November 2011
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Purpose
A study to assess whether the Northern Hemisphere 2008/2009 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Inflexal V |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2008/2009-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations |
Resource links provided by NLM:
Further study details as provided by Crucell Holland BV:
Primary Outcome Measures:
- Seroconversion [ Time Frame: Day 22 ± 2 days ] [ Designated as safety issue: No ]Seroconversion rate was defined as the proportion of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40
- Seroprotection [ Time Frame: Day 22 ± 2 days ] [ Designated as safety issue: No ]Seroprotection rate, defined as the proportion of subjects with HI antibody titer ≥1:40
- Fold Increase in Geometric Mean Titer (GMT) [ Time Frame: Day 22/Day 1 ] [ Designated as safety issue: No ]GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Secondary Outcome Measures:
- Safety: Incidence of Solicited Local Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Day 22 ] [ Designated as safety issue: Yes ]Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
- Incidence of Solicited Systemic Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Day 22 ] [ Designated as safety issue: Yes ]Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
| Enrollment: | 111 |
| Study Start Date: | July 2008 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Adults from 18 to 60 years old inclusive
|
Biological: Inflexal V
Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2008-2009 season, containing per 0.5 mL dose:
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1 |
|
Experimental: Group B
Elderly subjects aged over 60 years
|
Biological: Inflexal V
Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2008-2009 season, containing per 0.5 mL dose:
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 study vaccine; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303510
Locations
| Switzerland | |
| 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 |
More Information
No publications provided
| Responsible Party: | Crucell Holland BV |
| ClinicalTrials.gov Identifier: | NCT01303510 History of Changes |
| Other Study ID Numbers: | INF-V-A002 |
| Study First Received: | February 23, 2011 |
| Results First Received: | October 10, 2011 |
| Last Updated: | November 15, 2011 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Crucell Holland BV:
|
Influenza Virus Vaccination Immunisation |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013