Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)
A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
-
-
-
San Jose, Costa Rica
- Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Children, adolescents, and adults 3 to 64 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion Criteria:
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
For additional entry criteria, please refer to protocol.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 2x7.5adj
Two doses of MF59 adjuvanted (adj) A/H1N1
|
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
|
|
Sperimentale: 7.5adj_1_8
MF59 adjuvanted (adj) A/H1N1 on days 1 and 8
|
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
|
|
Sperimentale: 7.5adj_1_22
MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22
|
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
|
|
Sperimentale: 15_1_22
A/H1N1 on study days 1 and 22
|
Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
|
|
Sperimentale: 2x15_1_22
Two doses of A/H1N1 (one in each arm) on study days 1 and 22
|
Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Lasso di tempo: Day 1 to day 387
|
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS). |
Day 1 to day 387
|
|
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Lasso di tempo: Day 1 to day 387
|
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS). |
Day 1 to day 387
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Age Distribution at Baseline
Lasso di tempo: Baseline
|
Baseline
|
|
|
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
Lasso di tempo: Day 1 to day 387
|
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS). |
Day 1 to day 387
|
|
HI GMRs, in 3 to <9 Years and 9 to 17 Years
Lasso di tempo: Day 1 to day 387
|
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS). |
Day 1 to day 387
|
|
HI GMR, in Adults 18 to 64 Years
Lasso di tempo: Day 1 to day 387
|
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the Per-Protocol Set (PPS). |
Day 1 to day 387
|
|
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
Lasso di tempo: 7 days and 21 days after each vaccination
|
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the per-protocol set (PPS). |
7 days and 21 days after each vaccination
|
|
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
Lasso di tempo: 7 days after each vaccination
|
Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination |
7 days after each vaccination
|
|
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
Lasso di tempo: 7 days after each vaccination
|
Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination. |
7 days after each vaccination
|
|
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
Lasso di tempo: 7 days after each vaccination
|
Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set. |
7 days after each vaccination
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Novartis Vaccines, Novartis Vaccines
Pubblicazioni e link 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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- V112_04
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