Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 Season

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier:
NCT01146015
First received: June 14, 2010
Last updated: August 24, 2011
Last verified: August 2011
  Purpose

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of subjects in good health: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly)


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2010/2011. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects and Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • HI titers and its derived parameters after 3 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 121
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: 1 Biological: Trivalent influenza subunit vaccine Influvac
3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1

  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 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. A history of Guillain-Barré syndrome or active neurological disease
  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 ClinicalTrials.gov identifier: NCT01146015

Locations
Belgium
Site Reference ID/Investigator# 44974
Tessenderlo, Belgium, 3890
Germany
Site Reference ID/Investigator# 44975
Hamburg, Germany, 22769
Sponsors and Collaborators
Abbott Biologicals
Quintiles
Investigators
Study Director: Hanka de Voogd, MD Abbott Healthcare Products B.V.
  More Information

No publications provided

Responsible Party: Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier: NCT01146015     History of Changes
Other Study ID Numbers: S201.3.130, 2010-018350-13
Study First Received: June 14, 2010
Last Updated: August 24, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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 October 19, 2014