- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00310804
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
-
Panevezys, Litauen
- 2nd Department of Internal Diseases, Panevezys Hospital,
-
Vilnius, Litauen
- Dept. Infectious Diseases and Microbiology of Vilnius University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 18 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.
Exclusion Criteria:
- 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
known or suspected impairment/alteration of immune function, for example resulting from:
- receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
- receipt of immunostimulants,
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,
- high risk for developing an immunocompromising disease
- history of drug or alcohol abuse
- laboratory-confirmed influenza disease within 6 months prior to Visit 1
- receipt of influenza vaccine within 6 months prior to Visit 1
- receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
- any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1
- if female, pregnant or breastfeeding
- if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
- planned relocation abroad during the study period
- any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: cTIV_lot 1
|
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1
|
Eksperimentell: cTIV_lot 2
|
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
|
Eksperimentell: cTIV_lot 3
|
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3
|
Aktiv komparator: TIV group
|
One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
Tidsramme: Day 22 postvaccination
|
The haemagglutinin Inhibition (HI) antibody titer response following
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
Tidsramme: 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. |
Day 22 postvaccination
|
Percentage of Subjects With HI Titers ≥40
Tidsramme: 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%. |
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
Tidsramme: 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. |
Day 22 postvaccination
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
Tidsramme: 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
|
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
Tidsramme: 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.
|
Day 1 - Day 181 postvaccination
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Novartis Vaccines, Novartis Vaccines & Diagnostics
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- V58P9
- EUDRACT: 2005-002257-47
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