- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00714285
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
9 maggio 2018 aggiornato da: GlaxoSmithKline
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.
The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
420
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Hradec Kralove, Cechia, 500 03
- GSK Investigational Site
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 60 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential, if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
- Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
- Confirmed influenza infection within a year preceding the study start.
- Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- History of hypersensitivity to a previous dose of influenza vaccine
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- History of administration of experimental/licensed vaccine.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Quadrivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Single intramuscular dose on Day 0.
|
|
Sperimentale: Quadrivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Single intramuscular dose on Day 0.
|
|
Comparatore attivo: Trivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Single intramuscular dose on Day 0.
|
|
Comparatore attivo: Trivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Single intramuscular dose on Day 0.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
Lasso di tempo: At Day 0 and Day 21
|
Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
|
At Day 0 and Day 21
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
Lasso di tempo: At Day 21
|
A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
|
At Day 21
|
|
HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
Lasso di tempo: Day 21
|
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
|
Day 21
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
Lasso di tempo: At Days 0 and 21
|
A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
|
At Days 0 and 21
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Lasso di tempo: During a 7 day (Days 0-6) follow-up period after vaccination
|
Solicited local symptoms assessed were pain, redness and swelling.
Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade.
Grade 3 pain was defined as considerable pain that prevented normal activity.
Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
|
During a 7 day (Days 0-6) follow-up period after vaccination
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Lasso di tempo: During a 7-day follow-up period (Days 0-6) after vaccination
|
Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling.
Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade.
Grade 3 pain was defined as pain that prevented normal activity.
Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
|
During a 7-day follow-up period (Days 0-6) after vaccination
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Lasso di tempo: During a 7-day follow-up period (Days 0-6) after vaccination
|
Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination.
Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities.
Grade 3 fever = oral temperature ≥39.0°C.
Related = symptoms considered by the investigator to have a causal relationship to vaccination
|
During a 7-day follow-up period (Days 0-6) after vaccination
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Lasso di tempo: During a 7-day follow-up period (Days 0-6) after vaccination
|
Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination.
Any fever = oral temperature ≥ 37.5 °C.
Grade 3 symptoms = symptoms that prevented normal activities.
Grade 3 fever = oral temperature above 39.0°C. .
Related = symptoms considered by the investigator to have a causal relationship to vaccination.
|
During a 7-day follow-up period (Days 0-6) after vaccination
|
|
Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
Lasso di tempo: During the entire study period (Days 0-180)
|
MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.
|
During the entire study period (Days 0-180)
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
Lasso di tempo: During a 21 day (Days 0-20) follow-up period after vaccination-
|
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination
|
During a 21 day (Days 0-20) follow-up period after vaccination-
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Lasso di tempo: During the entire study period (Days 0-180)
|
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
|
During the entire study period (Days 0-180)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
14 luglio 2008
Completamento primario (Effettivo)
28 gennaio 2009
Completamento dello studio (Effettivo)
28 gennaio 2009
Date di iscrizione allo studio
Primo inviato
11 luglio 2008
Primo inviato che soddisfa i criteri di controllo qualità
11 luglio 2008
Primo Inserito (Stima)
14 luglio 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 giugno 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 maggio 2018
Ultimo verificato
1 marzo 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 111295
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Dati/documenti di studio
-
Modulo di consenso informato
Identificatore informazioni: 111295Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Rapporto di studio clinico
Identificatore informazioni: 111295Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Modulo di segnalazione del caso annotato
Identificatore informazioni: 111295Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Protocollo di studio
Identificatore informazioni: 111295Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Set di dati del singolo partecipante
Identificatore informazioni: 111295Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Specifica del set di dati
Identificatore informazioni: 111295Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Piano di analisi statistica
Identificatore informazioni: 111295Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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 GSK Biologicals' quadrivalent influenza vaccine
-
GlaxoSmithKlineCompletato
-
GlaxoSmithKlineCompletato
-
GlaxoSmithKlineCompletato
-
GlaxoSmithKlineCompletatoInfezioni, streptococcoNigeria, Mali
-
GlaxoSmithKlineCompletato
-
GlaxoSmithKlineCompletato
-
GlaxoSmithKlineCompletatoInfezioni, papilloma virus | Vaccini contro il papilloma virusBelgio
-
GlaxoSmithKlineCompletato
-
GlaxoSmithKlineAerasCompletato
-
GlaxoSmithKlineCompletatoMelanomaFrancia, Italia, Germania, Olanda, Svizzera, Regno Unito, Austria, Australia