- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00831987
Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine
Annual Study of Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005
To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.
To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The time of onset and duration of local and systemic solicited reactions will be assessed and reported. Unsolicited adverse events (including serious adverse events) will be collected and categorized throughout the study period.
Antibody levels will be evaluated by hemagglutination inhibition (HI) assay from sera obtained pre-vaccination (Day 0) and 21 days post-vaccination, for antigens from the 2004-2005 influenza virus strains: A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2), and B/Jiangsu/10/2003.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
Virginia
-
Norfolk, Virginia, Stati Uniti, 23507
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria :
- Participant aged 18 years or older.
- Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
- Participant is in reasonably good health as assessed by the investigator.
- Participant willing and able to meet protocol requirements.
- Participant willing and able to give informed consent.
Exclusion Criteria :
- Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
- An acute illness with or without fever (temperature >100.4°F) in the 72 hours preceding enrollment in the trial.
- Clinically significant findings in vital signs (including temperature >100.4°F) on review of systems.
- Self-reported history of severe adverse event to any influenza vaccine.
- Vaccination against influenza in the 6 months preceding enrollment in the study.
- Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
- Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study.
- Immunogenicity or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 3 months.
- Receipt of blood or blood products within the 3 months preceding enrollment in the study.
- Diabetes mellitus requiring pharmacological control.
- Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine.
- Person deprived of freedom by an administrative or court order (having legal or medical guardian).
- For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Fluzone® Vaccine Group - Age 18-59 Years
Participants aged 18 to 59 years at enrollment and received 1 dose of Fluzone® Vaccine
|
0.5 mL, Intramuscular
Altri nomi:
|
Sperimentale: Fluzone® Vaccine Group - Age ≥ 60 Years
Participants aged at least 60 years or older at enrollment and received 1 dose of Fluzone® Vaccine
|
0.5 mL, Intramuscular
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Lasso di tempo: 0 to 3 days post-vaccination
|
Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site. Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia |
0 to 3 days post-vaccination
|
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
Lasso di tempo: Day 0 and Day 21 Post-Vaccination
|
GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.
|
Day 0 and Day 21 Post-Vaccination
|
Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
Lasso di tempo: 21 Days post-vaccination
|
21 Days post-vaccination
|
|
Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
Lasso di tempo: Day 21 post-vaccination
|
Day 21 post-vaccination
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GRC20
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Fluzone®: Influenza virus vaccine 2004-2005 formulation
-
Sanofi Pasteur, a Sanofi CompanyCompletato