Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers
18 settembre 2018 aggiornato da: GlaxoSmithKline
Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers
This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study.
The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
957
Fase
- Fase 3
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
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Mengshan Town, Cina
- GSK Investigational Site
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Guangxi
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Wuzhou, Guangxi, Cina
- GSK Investigational Site
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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 1 anno a 2 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
- Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
- Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
- Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) or planned administration during the study period.
- 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.
- Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT01021293.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- Acute disease and/or fever at the time of enrolment.
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: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Group A
Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age.
Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care.
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Single dose, intramuscular administration
Single dose, intramuscular injection.
Part of the local standard of care.
No outcome measures associated.
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Comparatore attivo: Group B
Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint.
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Single dose, intramuscular injection.
Part of the local standard of care.
No outcome measures associated.
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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 Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Lasso di tempo: One month after Poliorix™ booster vaccination.
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A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50).
This outcome measure concerns subjects in the Poliorix Group only.
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One month after Poliorix™ booster vaccination.
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Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Lasso di tempo: Before booster vaccination.
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A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
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Before booster vaccination.
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Antibody Titers Against Poliovirus Type 1, 2 and 3
Lasso di tempo: One month after Poliorix™ booster vaccination.
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Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs).
This outcome measure concerns subjects in the Poliorix Group only.
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One month after Poliorix™ booster vaccination.
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Antibody Titers Against Poliovirus Type 1, 2 and 3.
Lasso di tempo: Before booster vaccination.
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Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
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Before booster vaccination.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Lasso di tempo: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
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Solicited local symptoms assessed were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = Cry when limb was moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
This outcome measure concerns subjects in the Poliorix Group only.
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Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Lasso di tempo: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
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Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever [defined as axillary temperature ≥ 37.1 degrees Celsius (°C)].
Any = occurence of any general symptom regardless of their intensity grade or relationship to study vaccine.
Grade 3 drowsiness = drowsiness that prevented normal activities.
Grade 3 fever = fever (axillary temperature) >39.0°C.
Grade 3 irritability = crying that could not be comforted/ prevented normal activity.
Grade 3 loss of appetite = not eating at all.
Related = symptom assessed by the investigator as causally related to the vaccination.
This outcome measure concerns subjects in the Poliorix Group only.
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Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
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Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Lasso di tempo: Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
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An unsolicited AE covers 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.
Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study.
Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
This outcome measure concerns subjects in the Poliorix Group only.
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Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
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Number of Subjects With Serious Adverse Events (SAEs)
Lasso di tempo: During the entire study period (Day 0 to Month 1).
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Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
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During the entire study period (Day 0 to Month 1).
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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
25 aprile 2011
Completamento primario (Effettivo)
19 settembre 2011
Completamento dello studio (Effettivo)
19 settembre 2011
Date di iscrizione allo studio
Primo inviato
24 marzo 2011
Primo inviato che soddisfa i criteri di controllo qualità
24 marzo 2011
Primo Inserito (Stima)
25 marzo 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 febbraio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 settembre 2018
Ultimo verificato
1 maggio 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 114306
Piano per i dati dei singoli partecipanti (IPD)
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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
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Specifica del set di dati
Identificatore informazioni: 114306Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Set di dati del singolo partecipante
Identificatore informazioni: 114306Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Rapporto di studio clinico
Identificatore informazioni: 114306Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Modulo di consenso informato
Identificatore informazioni: 114306Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Piano di analisi statistica
Identificatore informazioni: 114306Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Protocollo di studio
Identificatore informazioni: 114306Commenti 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 .