- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00471081
Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.
11 giugno 2019 aggiornato da: GlaxoSmithKline
Study to Assess Immunogenicity, Reactogenicity and Safety of Primary Vaccination With GSK Biologicals' MenACWY Vaccine (GSK134612) Given as 1 or 2 Doses to Healthy Toddlers 9-12 Months of Age
The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the FDA amendment Act, Sep 2007.
Sections impacted are Brief Title, Official Title of the study, Brief Summary, Key Inclusion & Exclusion criteria.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
385
Fase
- Fase 2
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
-
-
Alabama
-
Birmingham, Alabama, Stati Uniti, 35205
- GSK Investigational Site
-
-
Arkansas
-
Benton, Arkansas, Stati Uniti, 72015
- GSK Investigational Site
-
Little Rock, Arkansas, Stati Uniti, 72205
- GSK Investigational Site
-
-
California
-
Antioch, California, Stati Uniti, 94509
- GSK Investigational Site
-
Fremont, California, Stati Uniti, 94538
- GSK Investigational Site
-
Hayward, California, Stati Uniti, 94545
- GSK Investigational Site
-
Madera, California, Stati Uniti, 93637
- GSK Investigational Site
-
Santa Rosa, California, Stati Uniti, 95403
- GSK Investigational Site
-
Vacaville, California, Stati Uniti, 95688
- GSK Investigational Site
-
-
Colorado
-
Lakewood, Colorado, Stati Uniti, 80226
- GSK Investigational Site
-
Littleton, Colorado, Stati Uniti, 80234
- GSK Investigational Site
-
Littleton, Colorado, Stati Uniti, 80122
- GSK Investigational Site
-
Westminster, Colorado, Stati Uniti, 80234
- GSK Investigational Site
-
Wheat Ridge, Colorado, Stati Uniti, 80033
- GSK Investigational Site
-
-
Georgia
-
Birmingham, Georgia, Stati Uniti, 35244
- GSK Investigational Site
-
-
Ohio
-
Canton, Ohio, Stati Uniti, 44718
- GSK Investigational Site
-
-
Pennsylvania
-
Erie, Pennsylvania, Stati Uniti, 16501
- GSK Investigational Site
-
Greenville, Pennsylvania, Stati Uniti, 16125
- GSK Investigational Site
-
-
Texas
-
Amarillo, Texas, Stati Uniti, 79124
- 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 9 mesi a 9 mesi (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
- A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment.
- Up to date on vaccinations based on ACIP recommendations and the standard practice at the investigational site.
- Written informed consent obtained from parents/guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine.
- Planned administration of a tetanus toxoid (TT) containing vaccine throughout the active phase of the study (through one month after the last vaccination).
- Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W and/or Y.
- History of meningococcal diseases.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
- A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrollment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active phase of the study (through one month after the last dose of study 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: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Group A
Single dose GSK134612.
|
One or 2 intramuscular injections.
|
Sperimentale: Group B
Two doses of GSK134612.
|
One or 2 intramuscular injections.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
Lasso di tempo: One month after the last dose (at Month 4)
|
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
|
One month after the last dose (at Month 4)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
Lasso di tempo: One month after the first dose (at Month 1)
|
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
|
One month after the first dose (at Month 1)
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
Lasso di tempo: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
|
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
|
At Month 1 (for GSK 134612 2 doses Group only) and Month 4
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
Lasso di tempo: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
|
Antibody titers were presented as geometric mean titers (GMTs).
|
At Month 1 (for GSK 134612 2 doses Group only) and Month 4
|
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
Lasso di tempo: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
|
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
|
At Month 1 (for GSK 134612 2 doses Group only) and Month 4
|
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
Lasso di tempo: At Month 1 (GSK 134612 2 doses Group only) and Month 4
|
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.
|
At Month 1 (GSK 134612 2 doses Group only) and Month 4
|
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
Lasso di tempo: At Month 1 (GSK 134612 2 doses Group only) and Month 4
|
Antibody titers were presented as geometric mean titers (GMTs).
|
At Month 1 (GSK 134612 2 doses Group only) and Month 4
|
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Lasso di tempo: At Month 1 (GSK 134612 2 doses Group only) and Month 4
|
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
|
At Month 1 (GSK 134612 2 doses Group only) and Month 4
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
Lasso di tempo: At Month 1 (GSK 134612 s doses Group only) and Month 4
|
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).
|
At Month 1 (GSK 134612 s doses Group only) and Month 4
|
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Lasso di tempo: At Month 1 (GSK 134612 2 doses Group only) and Month 4
|
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
|
At Month 1 (GSK 134612 2 doses Group only) and Month 4
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Lasso di tempo: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
|
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
|
During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Lasso di tempo: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
|
Assessed solicited general symptoms were drowsiness, fever [defined as axillary, oral, tympanic or rectal temperature equal to or above (≥) 38 degrees Celsius (°C)], irritability and loss of appetite.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever higher than (>) 40.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
|
During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Lasso di tempo: Up to 1 month post-vaccination
|
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 and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
|
Up to 1 month post-vaccination
|
Number of Subjects With Serious Adverse Events (SAEs)
Lasso di tempo: Up to study end (Month 9)
|
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
Up to study end (Month 9)
|
Number of Subjects With New Onset Chronic Ilnesses (NOCI)
Lasso di tempo: Up to study end (Month 9)
|
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
|
Up to study end (Month 9)
|
Number of Subjects Reporting Rash
Lasso di tempo: Up to study end (Month 9)
|
Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.
|
Up to study end (Month 9)
|
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Lasso di tempo: Up to study end (Month 9)
|
Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.
|
Up to study end (Month 9)
|
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.
Pubblicazioni generali
- Klein NP, Baine Y, Bianco V, Lestrate PR, Naz A, Blatter M, Friedland LR, Miller JM. One or two doses of quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine is immunogenic in 9- to 12-month-old children. Pediatr Infect Dis J. 2013 Jul;32(7):760-7. doi: 10.1097/INF.0b013e31828693c5.
- Klein N et al. Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Toddlers: 1-year Persistence. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.
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 (Effettivo)
5 luglio 2007
Completamento primario (Effettivo)
23 ottobre 2008
Completamento dello studio (Effettivo)
26 novembre 2008
Date di iscrizione allo studio
Primo inviato
8 maggio 2007
Primo inviato che soddisfa i criteri di controllo qualità
8 maggio 2007
Primo Inserito (Stima)
9 maggio 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 giugno 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 giugno 2019
Ultimo verificato
1 giugno 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 109375
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
IPD for this study will be made available via the Clinical Study Data Request site.
Periodo di condivisione IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Criteri di accesso alla condivisione IPD
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
Dati/documenti di studio
-
Modulo di segnalazione del caso annotato
Identificatore informazioni: 109375Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Specifica del set di dati
Identificatore informazioni: 109375Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Piano di analisi statistica
Identificatore informazioni: 109375Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Set di dati del singolo partecipante
Identificatore informazioni: 109375Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Modulo di consenso informato
Identificatore informazioni: 109375Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Rapporto di studio clinico
Identificatore informazioni: 109375Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Protocollo di studio
Identificatore informazioni: 109375Commenti 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 Meningococcal vaccine GSK134612
-
GlaxoSmithKlineCompletatoInfezioni, MeningococcoStati Uniti
-
GlaxoSmithKlineCompletatoInfezioni, Meningococco | Vaccini meningococciciGermania, Francia
-
GlaxoSmithKlineCompletatoInfezioni, MeningococcoFinlandia
-
PfizerCompletatoInfezioni, MeningococcoFilippine
-
PfizerCompletato
-
GlaxoSmithKlineCompletatoInfezioni, MeningococcoTaiwan, Filippine, India
-
GlaxoSmithKlineCompletatoInfezioni, MeningococcoGermania, Austria, Grecia
-
GlaxoSmithKlineCompletatoInfezioni, MeningococcoFilippine, Libano
-
GlaxoSmithKlineCompletatoInfezioni, MeningococcoTailandia, Estonia, Repubblica Dominicana
-
GlaxoSmithKlineCompletatoInfezioni, MeningococcoGermania, Corea, Repubblica di, Repubblica Dominicana