A Study to Assess Immunogenicity Parameters After Vaccination Against Influenza and to Evaluate How These Parameters Change During the Influenza Season

NCT01457027 | Completed Phase 4

• 1 other identifier: INF-V-A007
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine strains and to assess the cross-protection against 4 selected circulating heterogeneous A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.

Conditions

Influenza

Keywords

Influenza; Virus; Vaccination; Immunisation

Outcome Measures

Primary Outcomes (3)

• Seroprotection

  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 will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

  3 weeks after vaccination (Day 22 ± 2 days)

• Seroconversion

  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 will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

  3 weeks after vaccination (Day 22 ± 2 days)

• Geometric Mean Titer

  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 will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

  3 weeks after vaccination (Day 22 ± 2 days)

Secondary Outcomes (3)

• Geometric Mean Titer

  6 months post-vaccination

• Seroprotection

  6 months post-vaccination

• Seroconversion

  6 months post-vaccination

Study Arms (1)

All subjects

EXPERIMENTAL

Biological: Inflexal V

Interventions

Inflexal V BIOLOGICAL

Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2011-2012 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

All subjects

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female and male adults aged \>60 years on the day of enrollment
• Written informed consent
• Females with confirmed menopause (postmenopausal is defined as 12 months with no menses without an alternative medical cause)

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 for season 2011/2012
• 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/day prednisolone or equivalent (inhaled or topical steroids are allowed)
• Known immunodeficiency (including leukemia, HIV seropositivity) or 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)
• Participation in another clinical trial
• Employee at the investigational site or relative of the investigator
• Anticipated non-compliance with study procedures

Sponsors & Collaborators

• Crucell Holland BV: lead

Study Sites (1)

Dept. of Health Sciences, University of Genoa and Hygiene Unit, "San Martino" University Hospital

Genoa, 16100, Italy

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

Study Officials

• Giancarlo Icardi, MD

  San Martino University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 21, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

IT (1)