A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 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:
NCT01306305
First received: February 28, 2011
Last updated: March 1, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Inflexal V |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-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 2010/2011-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
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 number 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 number 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: Numbers of Subjects Reporting Solicited Local Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Days 8, 15 and 22 ] [ Designated as safety issue: Yes ]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 [ Time Frame: Days 1 to 4 inclusive, and Days 8, 15 and 22 ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 110 |
| Study Start Date: | June 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Elderly
Elderly subjects aged over 60 years
|
Biological: Inflexal V
Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2010-2011 season, containing per 0.5 mL dose:
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1 |
|
Experimental: Adults
Adults from 18 to 60 years old inclusive
|
Biological: Inflexal V
Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2010-2011 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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306305
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: | NCT01306305 History of Changes |
| Other Study ID Numbers: | INF-V-A004 |
| Study First Received: | February 28, 2011 |
| Results First Received: | March 1, 2012 |
| Last Updated: | March 1, 2012 |
| 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 June 17, 2013