- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00554333
Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine
An Open-label, Multi-centre, Randomised, Comparative Study of the Immunogenicity and Safety of an Inactivated Split-Virion Influenza Vaccine Administered by Intradermal Route (Flu-ID 15μg) Versus an Inactivated Adjuvanted Influenza Vaccine Administered by Intramuscular Route in Subjects 65 Years of Age or Older
Primary objective:
* Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres
Secondary objectives
Immunogenicity
- To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route..
- To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects
Safety
- To describe the safety profile after vaccination in each group
Acceptability
- To describe the pain at the injection site
- To describe the comfort of the injection
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Aged 65 years or older on the day of inclusion
Exclusion Criteria:
- Febrile illness (oral temperature ≥37.5°C) on the day of inclusion
- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- Unstable chronic illness
- Congenital or acquired immunodeficiency,
- Any blood or blood-derived product in the past 3 months
- Current abuse of alcohol or drug addiction
- Any vaccination in the past 4 weeks or planned in the 4 weeks following study vaccination
- Any vaccination against influenza in the past 6 months
- Subjects who previously received a vaccination against influenza by intradermal route
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
Inactivated Split-Virion Influenza Vaccine for Intradermal Route
|
Inactivated Split-Virion Influenza Vaccine for Intradermal Route
|
Aktiv komparator: 2
Inactivated adjuvanted Influenza Vaccine for Intramuscular Route
|
Inactivated adjuvanted Influenza Vaccine for Intramuscular Route
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.
Tidsramme: 21 days
|
21 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0]
Tidsramme: 21 days
|
21 days
|
Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21
Tidsramme: 21 days
|
21 days
|
Seroconversion or significant increase status at Day 21:anti-HA individual post-vaccination titre ≥40 (1/dil) on D21 for subjects with a pre-vaccination anti-HA individual titre <10 (1/dil) on D0
Tidsramme: 21 days
|
21 days
|
Seroconversion or significant increase status at D21: ≥4-fold increase from pre- to post-vaccination anti-HA individual titre on D21 for subjects with a pre-vaccination anti-HA individual titre ≥10 (1/dil)
Tidsramme: 21 days
|
21 days
|
Occurrence, time to onset, number of days of occurrence, and intensity of solicited injection site adverse reactions and systemic adverse reactions occurring from D0 to D7 after vaccination
Tidsramme: 7 days
|
7 days
|
Occurrence of some solicited adverse reactions occurring from D0 to D3 after vaccination as defined by the EMEA Note for Guidance [CPMP/BWP/214/96]
Tidsramme: 3 days
|
3 days
|
Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of unsolicited (spontaneously reported) adverse events (injection site and systemic) occurring from D0 to visit 2
Tidsramme: 21 days (plus or minus 3 days)
|
21 days (plus or minus 3 days)
|
Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of serious adverse events occurring from D0 to visit 2
Tidsramme: 21 days (plus or minus 3 days)
|
21 days (plus or minus 3 days)
|
Intensity of pain at the time of injection evaluated just after vaccination on D0 using a Verbal Rating Scale
Tidsramme: 1 day (day of vaccination)
|
1 day (day of vaccination)
|
Answers to the Vaccination Comfort Questionnaire completed on D21
Tidsramme: 21 days
|
21 days
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FID01C
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