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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.
Information provided by (Responsible Party):
Abbott ( Abbott Biologicals ) Identifier:
First received: July 2, 2012
Last updated: August 3, 2012
Last verified: August 2012
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: Intervention Model: Single Group Assignment
Masking: None (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:

Further study details as provided by Abbott ( Abbott Biologicals ):

Primary Outcome Measures:
  • Antihemagglutinin antibody titers and the derived parameters seroprotection, seroconversion and mean fold increase [ Time Frame: 3 weeks ]
    Standard parameters to quantify antibody levels. Recommended in the CHMP guideline.

  • Solicited local and systemic reactions, overall inconvenience [ Time Frame: 3 days ]
    Reactogenicity and inconvenience

  • Unsolicited adverse events [ Time Frame: 3 weeks ]
    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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01633749

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

Responsible Party: Abbott Biologicals Identifier: NCT01633749     History of Changes
Other Study ID Numbers: M13-567
2012-001032-57 ( EudraCT Number )
Study First Received: July 2, 2012
Last Updated: August 3, 2012

Keywords provided by Abbott ( Abbott Biologicals ):
CHMP criteria

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017