- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01751165
Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older
Open-label Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Tartu, Estonia, 50106
- GSK Investigational Site
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California
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Spring Valley, California, Stati Uniti, 91978
- GSK Investigational Site
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Kansas
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Wichita, Kansas, Stati Uniti, 67207
- GSK Investigational Site
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Pennsylvania
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Uniontown, Pennsylvania, Stati Uniti, 15401
- GSK Investigational Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female aged 50 years or older at the time of the first vaccination.
- Written informed consent obtained from the subject.
Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, a prednisone dose of < 20 mg/day, or equivalent, is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
- Administration or planned administration of a live vaccine in the period starting 30 days before and ending 30 days after either dose of study vaccine.
- Administration or planned administration of a non-replicating vaccine within eight days prior to or within 14 days after either dose of study vaccine.
- Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.
- Previous vaccination against varicella or HZ (either registered product or participation in a previous vaccine study).
- Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
- History of HZ.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g. malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g. medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C (99.5°F) for oral, axillary or tympanic route, or ≥ 38.0°C (100.4°F) for rectal route. The preferred route for recording temperature in this study will be oral.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.
- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
- Pregnant or lactating female.
- Female planning to become pregnant during the entire treatment period and for two months after completion of the vaccination series, or planning to discontinue contraceptive precautions (if of childbearing potential).
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 |
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Sperimentale: HZ/su-0,2 Group
Subjects will receive HZ/su vaccine on a 0,2-month schedule.
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2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
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Sperimentale: HZ/su-0,6 Group
Subjects will receive HZ/su vaccine on a 0,6-month schedule.
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2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
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Sperimentale: HZ/su-0,12 Group
Subjects will receive HZ/su vaccine on a 0,12-month schedule.
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2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA).
Lasso di tempo: At one month (M1) after Dose 2
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Vaccine response was defined as: for initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. The objective required a comparison of VRR between 0,6-months and 0,12-months schedules. |
At one month (M1) after Dose 2
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Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
Lasso di tempo: At one month (M1) after Dose 2
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At one month (M1) after Dose 2
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
Lasso di tempo: Prior (PRE) to vaccination and twelve (M12) post Dose 2
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Prior (PRE) to vaccination and twelve (M12) post Dose 2
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Number of Subjects With Solicited Local Symptoms.
Lasso di tempo: During the 7 day period (Days 0-6) following each dose (D)
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Solicited local symptoms assessed include pain, redness and swelling.
"Grade 3 pain" was defined as crying when limb was moved/spontaneously painful.
"Grade 3 swelling/redness" was defined as swelling/redness larger than (>) 100 millimeters (mm).
"Any" is defined as incidence of the specified symptom regardless of intensity.
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During the 7 day period (Days 0-6) following each dose (D)
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Number of Subjects With Solicited General Symptoms.
Lasso di tempo: During the 7 day period (Days 0-6) following each dose (D)
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Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than [≥] 37.5 degrees Celsius [°C]).
"Any" = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination.
"Related" = occurrence of the specified symptom assessed by the investigators as causally related to vaccination.
"Grade 3 Fatigue" = fatigue that prevented normal activity.
"Grade 3 Gastrointestinal" = gastrointestinal that prevented normal every day activities.
"Grade 3 Headache" = headache that prevented normal activity.
"Grade 3 Myalgia" = myalgia that prevented normal activity.
"Grade 3 Shivering" = shivering that prevented normal activity.
"Grade 3 Temperature" = temperature higher than (>) 39.0°C.
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During the 7 day period (Days 0-6) following each dose (D)
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Number of Subjects With Unsolicited Adverse Events (AEs).
Lasso di tempo: During the 30 Days (Day 0-29) following vaccination
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An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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During the 30 Days (Day 0-29) following vaccination
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Number of Subjects With Serious Adverse Events (SAEs).
Lasso di tempo: From first vaccination up to one month (30 Days) post last vaccination
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SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
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From first vaccination up to one month (30 Days) post last vaccination
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Number of Subjects With SAE(s).
Lasso di tempo: Starting from 30 Days post last vaccine administration up to study end at Month 24
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SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
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Starting from 30 Days post last vaccine administration up to study end at Month 24
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Number of Days With Solicited Local Symptoms.
Lasso di tempo: During the 7 Days (Day 0-6) following vaccination
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Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.
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During the 7 Days (Day 0-6) following vaccination
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Number of Days With Solicited General Symptoms.
Lasso di tempo: During the 7 Days (Day 0-6) following vaccination
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Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.
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During the 7 Days (Day 0-6) following vaccination
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Number of Subjects With Potential Immune-mediated Diseases (pIMDs).
Lasso di tempo: From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)
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pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
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From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)
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Number of Subjects With pIMDs.
Lasso di tempo: From one month (30 Days) following the last vaccine administration up to study end at Month 24
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pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
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From one month (30 Days) following the last vaccine administration up to study end at Month 24
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Collaboratori e investigatori
Sponsor
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 (Effettivo)
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
- 116697
- 2012-004456-11 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
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 Fuoco di Sant'Antonio
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Immorna Biotherapeutics, Inc.ICON plcAttivo, non reclutanteMalattia infettiva | Herpes zoster | Herpes zoster (HZ)Stati Uniti
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PfizerReclutamentoHerpes zoster | Umano | Infezione da herpes zosterStati Uniti
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Northwestern UniversityBausch & Lomb IncorporatedTerminatoHerpes zoster cheratiteStati Uniti
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Curevo IncGreen Cross Corporation; Mogam Biotechnology Research InstituteAttivo, non reclutanteFuoco di Sant'Antonio | Herpes zosterStati Uniti
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University of Colorado, DenverGlaxoSmithKlineCompletatoFuoco di Sant'Antonio | Herpes zosterStati Uniti
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Bristol-Myers SquibbCompletatoFuoco di Sant'Antonio | Herpes zoster
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Emory UniversityNational Institute of Allergy and Infectious Diseases (NIAID)CompletatoZoster | Zoster varicella | Herpes zoster | VaricellaStati Uniti
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Tanta UniversityNon ancora reclutamentoGestione del dolore acuto da Herpes Zoster
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Centrexion TherapeuticsTerminatoDolore da herpes zoster ad esordio acutoAustralia
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The University of Hong KongReclutamentoNeuropatia acuta da herpes zosterHong Kong
Prove cliniche su Herpes zoster vaccine GSK1437173A
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GlaxoSmithKlineCompletatoFuoco di Sant'AntonioStati Uniti, Australia, Spagna, Finlandia, Germania, Giappone, Taiwan, Svezia, Corea, Repubblica di, Brasile, Messico, Canada, Italia, Francia, Cechia, Estonia, Hong Kong, Regno Unito
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GlaxoSmithKlineCompletatoFuoco di Sant'AntonioAustralia
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University Health Network, TorontoCompletatoVaccino Varicella ZosterCanada
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GlaxoSmithKlineCompletatoFuoco di Sant'AntonioStati Uniti, Australia, Spagna, Finlandia, Germania, Giappone, Taiwan, Canada, Svezia, Corea, Repubblica di, Cechia, Hong Kong, Messico, Italia, Brasile, Estonia, Francia, Regno Unito
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GlaxoSmithKlineCompletatoFuoco di Sant'AntonioGermania, Cechia, Svezia
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GlaxoSmithKlineCompletatoFuoco di Sant'AntonioStati Uniti, Australia, Germania, Spagna, Finlandia, Giappone, Taiwan, Svezia, Corea, Repubblica di, Hong Kong, Messico, Canada, Italia, Francia, Brasile, Estonia, Regno Unito, Cechia
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GlaxoSmithKlineCompletatoFuoco di Sant'Antonio | Vaccino contro l'herpes zosterStati Uniti, Australia, Spagna, Finlandia, Germania, Giappone, Taiwan, Canada, Svezia, Corea, Repubblica di, Cechia, Hong Kong, Messico, Italia, Brasile, Estonia, Francia, Regno Unito
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GlaxoSmithKlineAttivo, non reclutanteFuoco di Sant'AntonioSpagna, Panama, Messico, Federazione Russa, Finlandia, Estonia, Hong Kong, Regno Unito
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NYU Langone HealthReclutamentoLupus eritematoso sistemicoStati Uniti
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GlaxoSmithKlineCompletato