A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere

NCT01306305 | Completed Phase 4 Results

• 1 other identifier: INF-V-A004
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Influenza

Keywords

Influenza; Virus; Vaccination; Immunisation

Outcome Measures

Primary Outcomes (3)

• 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

  Day 22 ± 2 days

• Seroprotection

  Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40

  Day 22 ± 2 days

• Fold Increase in Geometric Mean Titer (GMT)

  GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value

  Day 22/Day 1

Secondary Outcomes (2)

• Safety: Numbers of Subjects Reporting Solicited Local Adverse Events

  Days 1 to 4 inclusive, and Days 8, 15 and 22

• Numbers of Subjects Reporting Solicited Systemic Adverse Events

  Days 1 to 4 inclusive, and Days 8, 15 and 22

Study Arms (2)

Elderly

EXPERIMENTAL

Elderly subjects aged over 60 years

Biological: Inflexal V

Adults

EXPERIMENTAL

Adults from 18 to 60 years old inclusive

Biological: Inflexal V

Interventions

Inflexal V BIOLOGICAL

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

Adults; Elderly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female and male adults
• Aged ≥18 to ≤60 years or \>60 years on Day 1
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Crucell Holland BV: lead

Study Sites (1)

Covance Clinical Research Unit AG

Allschwil, 4123, Switzerland

Location

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Interventions

Inflexal V

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Affairs Director
• Organization: Crucell Switzerland AG

info@crucell.com

+41(0)319806111

Study Officials

• Michael Seiberling, MD

  Covance Clinical Research Unit AG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 1, 2011
• Study Start: June 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 9, 2013
• Results First Posted: March 29, 2012

Record last verified: 2013-08

Locations

CH (1)