Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier:
NCT00999206
First received: October 20, 2009
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity


Condition Intervention Phase
Influenza
Biological: Influenza Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 3138
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Experimental: 2 Biological: Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Experimental: 3 Biological: Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Active Comparator: 4 Biological: Influenza Vaccine
surface antigen, inactivated, prepared in egg (influvac ®)

  Eligibility

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

Inclusion Criteria

  1. Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or elderly >= 61 years of age).
  2. Willing and able to give informed consent before any protocol procedures are performed.
  3. Able to adhere to visit schedules and all protocol required study procedures.
  4. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).

Exclusion Criteria

  1. Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
  2. Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
  3. A serious adverse reaction after a previous (influenza) vaccination.
  4. A history of Guillain-Barré syndrome.
  5. Known to be allergic to constituents of the study vaccines.
  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: NCT00999206

Locations
Australia
Site Reference ID/Investigator# 44652
Adelaide, Australia, 5000
Site Reference ID/Investigator# 44662
Auchenflower, Australia, 4066
Site Reference ID/Investigator# 44659
Blacktown, Australia, 2148
Site Reference ID/Investigator# 44651
Blacktown, Australia, 2148
Site Reference ID/Investigator# 44647
Broadmeadow, Australia, 2292
Site Reference ID/Investigator# 44649
Caboolture, Australia, 4510
Site Reference ID/Investigator# 44646
Carina Heights, Australia, 4152
Site Reference ID/Investigator# 44650
Herston, Australia, 4006
Site Reference ID/Investigator# 44663
Hornsby, Australia, 2077
Site Reference ID/Investigator# 44645
Kippa-Ring, Australia, 4020
Site Reference ID/Investigator# 44644
Malvern East, Australia, 3145
Site Reference ID/Investigator# 44648
Maroubra Junction, Australia, 2035
Site Reference ID/Investigator# 44643
Sherwood, Australia, 4075
New Zealand
Site Reference ID/Investigator# 44653
Christchurch, New Zealand
Site Reference ID/Investigator# 44658
Dunedin, New Zealand, 9012
Site Reference ID/Investigator# 44656
Grafton, New Zealand, 1150
Site Reference ID/Investigator# 44655
Rotorua, New Zealand, 3010
Site Reference ID/Investigator# 44654
Tauranga, New Zealand, 3110
Site Reference ID/Investigator# 44657
Wellington, New Zealand, 6035
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: NCT00999206     History of Changes
Other Study ID Numbers: S203.3.013
Study First Received: October 20, 2009
Last Updated: August 25, 2011
Health Authority: Australia: National Health and Medical Research Council
New Zealand: Medsafe

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 August 20, 2014