Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine
This study has been completed.
Sponsor:
Abbott Biologicals
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
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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:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
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
- Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or elderly >= 61 years of age).
- Willing and able to give informed consent before any protocol procedures are performed.
- Able to adhere to visit schedules and all protocol required study procedures.
- 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
- 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).
- Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
- A serious adverse reaction after a previous (influenza) vaccination.
- A history of Guillain-Barré syndrome.
- Known to be allergic to constituents of the study vaccines.
Contacts and Locations
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 June 13, 2013