Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)
BiologicalOne single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1
NCT Number: NCT00310804
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 3
2nd Department of Internal Diseases, Panevezys Hospital,, Panevezys, Lithuania
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Day 22 postvaccination
The haemagglutinin Inhibition (HI) antibody titer response following
The HI GMTs were evaluated using egg-derived antigen assay.
Time frame: Day 22 postvaccination
Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following
The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5.
Time frame: Day 22 postvaccination
Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after
European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >70%.
Time frame: Day 22 postvaccination
Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after
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.
Time frame: Day 1 to Day 7 postvaccination
To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of
Time frame: Day 1 - Day 181 postvaccination
Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.
Novartis Vaccines
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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