Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)
A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult Subjects Aged >=18 to <=60
2 other identifiers
interventional
1,200
1 country
2
Brief Summary
The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2005
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 3, 2006
CompletedFirst Posted
Study publicly available on registry
April 5, 2006
CompletedResults Posted
Study results publicly available
January 18, 2013
CompletedAugust 15, 2019
August 1, 2019
1 month
April 3, 2006
December 11, 2012
August 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
The haemagglutinin Inhibition (HI) antibody titer response following 1. one dose of cTIV for each of the three lots separately and 2. one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs). The HI GMTs were evaluated using egg-derived antigen assay.
Day 22 postvaccination
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is \>2.5.
Day 22 postvaccination
Percentage of Subjects With HI Titers ≥40
Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is \>70%.
Day 22 postvaccination
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine
Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after 1. one dose of cTIV for each of the three vaccine lots separately and 2. one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is \>40%. As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer \<10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination.
Day 22 postvaccination
Secondary Outcomes (2)
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
Day 1 to Day 7 postvaccination
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
Day 1 - Day 181 postvaccination
Study Arms (4)
cTIV_lot 1
EXPERIMENTALcTIV_lot 2
EXPERIMENTALcTIV_lot 3
EXPERIMENTALTIV group
ACTIVE COMPARATORInterventions
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3
One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
Eligibility Criteria
You may qualify if:
- to \<61 years of age
- mentally competent to understand the nature, the scope and the consequences of the study
- able and willing to give written informed consent prior to study entry
- in good health as determined by:
- medical history,
- physical examination,
- clinical judgment of the Investigator.
You may not qualify if:
- unwilling or unable to give written informed consent to participate in the study
- participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
- currently experiencing an acute infectious disease
- any serious disease, such as, for example:
- cancer,
- autoimmune disease (including rheumatoid arthritis),
- advanced arteriosclerotic disease or complicated diabetes mellitus,
- chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
- acute or progressive hepatic disease,
- acute or progressive renal disease,
- congestive heart failure
- surgery planned during the study period
- bleeding diathesis
- history of hypersensitivity to any component of the study medication or chemically related substances
- history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
2nd Department of Internal Diseases, Panevezys Hospital,
Panevezys, Lithuania
Dept. Infectious Diseases and Microbiology of Vilnius University
Vilnius, Lithuania
Related Publications (1)
Ambrozaitis A, Groth N, Bugarini R, Sparacio V, Podda A, Lattanzi M. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine. 2009 Oct 9;27(43):6022-9. doi: 10.1016/j.vaccine.2009.07.083. Epub 2009 Aug 8.
PMID: 19666152RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Because of potential issues related to Good Clinical Practice (GCP), data from one of the sites were not used in the analyses.
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines & Diagnostics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2006
First Posted
April 5, 2006
Study Start
September 1, 2005
Primary Completion
October 1, 2005
Study Completion
April 1, 2006
Last Updated
August 15, 2019
Results First Posted
January 18, 2013
Record last verified: 2019-08