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Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 Season

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier:
NCT01633749
First received: July 2, 2012
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose

Annual study to investigate influenza vaccine (flu vaccine) developed for the 2012/2013 season for the prevention of influenza infection. The immunizing effect is being investigated, as well as its tolerability and safety.


Condition Intervention Phase
Prophylaxis of Influenza
 Biological: Trivalent influenza subunit vaccine Influvac
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Northern Hemisphere Season 2012/2013. An Open-label, Baseline-controlled Study in Two Age Groups: Adult Subjects ≥ 18 and ≤ 60 Years and Elderly Subjects ≥ 61 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Antihemagglutinin antibody titers and the derived parameters seroprotection, seroconversion and mean fold increase [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Standard parameters to quantify antibody levels. Recommended in the CHMP guideline.

  • Solicited local and systemic reactions, overall inconvenience [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Reactogenicity and inconvenience

  • Unsolicited adverse events [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Other adverse events


Enrollment: 120
Study Start Date: July 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trivalent influenza subunit vaccine Influvac
3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1
 Biological: Trivalent influenza subunit vaccine Influvac
3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1
Other Name: ABT-SLV201, trivalent influenza subunit vaccine, Influvac

Detailed Description:

An open, baseline-controlled study in two age groups: adults and elderly. The subjects will be screened within 14 days prior to or at Visit 1 (Day 1). At Visit 1 (Day 1) subjects will be vaccinated after blood sampling for baseline serum antihemagglutinin antibody titration. Subjects will be asked to record local and systemic reactions daily on a diary at home for 72 hours after vaccination. One week later (Visit 2, Day 8) the subjects will return to the study site to hand in the diary and for the assessment of safety and tolerability (reactogenicity and overall inconvenience). Three weeks after vaccination (Visit 3, Day 22) the subjects will return to the study site for blood sampling to assess immunogenicity and for the assessment of safety and tolerability.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
  2. Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
  3. Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator.

Exclusion Criteria

  1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
  2. A serious adverse reaction after a previous (influenza) vaccination.
  3. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
  4. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
  5. Having any condition which suppresses the immune system and autoimmune disorders.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633749

Locations
Germany
Site Reference ID/Investigator# 74593
Hamburg, Germany, 22769
Sponsors and Collaborators
Abbott Biologicals
Investigators
Study Director: Serge van de Witte, PhD Abbott Healthcare Products BV
  More Information

No publications provided

Responsible Party: Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier: NCT01633749     History of Changes
Other Study ID Numbers: M13-567, 2012-001032-57
Study First Received: July 2, 2012
Last Updated: August 3, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Paul-Ehrlich-Institut

Keywords provided by Abbott:
Influenza
Vaccine
CHMP criteria

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 19, 2013