- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01061541
Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™
A Phase II, Double-blind, Randomized Study to Compare the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB/Hib2.5 to GSK Biologicals' Tritanrix™-HepB/Hiberix™ When Administered as a Three-dose Primary Vaccination Course to Healthy Infants at 6, 10 and 14 Weeks of Age. A Dose of Unconjugated Hib Vaccine (Plain PRP Booster) Will be Administered at the Age of 10 Months to 50% of the Subjects
In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5). The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive Tritanrix™-HepB/Hiberix™.
Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects 50% were randomised to participate in the PRP challenge study (208108/092) (open), and all subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Muntinlupa, Filippine, 1781
- 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 the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks.
- Born to a mother proven seronegative for HBsAg.
Exclusion Criteria:
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine, with the exception of oral polio vaccine (OPV).
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) 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 since birth.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B and/or Hib.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Hib disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions 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 enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or history.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Gruppo A
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One dose as intramuscular injection at 6, 10 and 14 weeks of age.
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
One dose as intramuscular injection at 10 months of age
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Comparatore attivo: Gruppo B
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One dose as intramuscular injection at 10 months of age
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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anti-PRP antibody concentration above a protocol defined cut-off value.
Lasso di tempo: One month after the third dose of the primary vaccination course.
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One month after the third dose of the primary vaccination course.
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Comparsa di sintomi sollecitati
Lasso di tempo: Durante il periodo di follow-up di 4 giorni dopo ciascuna dose
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Durante il periodo di follow-up di 4 giorni dopo ciascuna dose
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anti-HBs antibody concentration
Lasso di tempo: One month after the third dose of the primary vaccination course
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One month after the third dose of the primary vaccination course
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anti-PRP antibody concentration
Lasso di tempo: One month after the third dose of the primary vaccination course
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One month after the third dose of the primary vaccination course
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anti-tetanus antibody concentration
Lasso di tempo: One month after the third dose of the primary vaccination course
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One month after the third dose of the primary vaccination course
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anti-diphtheria antibody concentration
Lasso di tempo: One month after the third dose of the primary vaccination course
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One month after the third dose of the primary vaccination course
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anti-Bordetella pertussis (BPT) antibody concentration
Lasso di tempo: One month after the third dose of the primary vaccination course
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One month after the third dose of the primary vaccination course
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Vaccine response to Bordetella pertussis antigen.
Lasso di tempo: One month after the third dose of the primary vaccination course
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One month after the third dose of the primary vaccination course
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Seropositivity/seroprotection rates and GMCs for antibodies against all vaccine antigens
Lasso di tempo: Before the first dose of the primary vaccination course
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Before the first dose of the primary vaccination course
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anti-PRP antibody concentration
Lasso di tempo: Before and one month after the plain PRP challenge dose.
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Before and one month after the plain PRP challenge dose.
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Occurrence of unsolicited symptoms
Lasso di tempo: During the 31-day follow-up period after each dose
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During the 31-day follow-up period after each dose
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Occurrence of serious adverse events
Lasso di tempo: Over the full course of the study
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Over the full course of the study
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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 (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 208108/091
- 208108/092 (Altro identificatore: GSK)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Dati/documenti di studio
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Specifica del set di dati
Identificatore informazioni: 208108/091Commenti 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: 208108/091Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 208108/091 are summarised with study 208108/092 on the GSK Clinical Study Register.
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Piano di analisi statistica
Identificatore informazioni: 208108/091Commenti 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: 208108/091Commenti 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: 208108/091Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Protocollo di studio
Identificatore informazioni: 208108/091Commenti 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 Haemophilus Influenzae Tipo b
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Johns Hopkins Bloomberg School of Public HealthMerck Sharp & Dohme LLCCompletatoInfezione da Haemophilus influenzae di tipo BStati Uniti
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Beijing Minhai Biotechnology Co., LtdSconosciutoInfezioni da Haemophilus Influenzae di tipo bCina
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Novartis VaccinesCompletatoInfezione da Haemophilus influenzae di tipo BCorea, Repubblica di
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Novartis VaccinesCompletatoHaemophilus Influenzae Tipo bCina
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GlaxoSmithKlineCompletatoNeisseria Meningitidis | Haemophilus Influenzae Tipo bAustralia
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Novartis VaccinesCompletatoHaemophilus Influenzae Tipo bCina
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GlaxoSmithKlineCompletatoNeisseria Meningitidis | Haemophilus Influenzae Tipo bBelgio, Germania
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GlaxoSmithKlineCompletatoNeisseria Meningitidis | Haemophilus Influenzae Tipo bStati Uniti, Messico
Prove cliniche su Tritanrix™-HepB low thio /
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GlaxoSmithKlineCompletatoEpatite B | Tetano | Difterite | Haemophilus Influenzae Tipo b | Pertosse a cellule intereFilippine
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GlaxoSmithKlineCompletatoInfezioni, MeningococcoFilippine
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GlaxoSmithKlineCompletatoEpatite B | Tetano | Difterite | Haemophilus Influenzae Tipo b | Pertosse a cellule intere | Difterite-Tetano-Pertosse-Epatite B-Haemophilus Influenzae Tipo b-Neisseria Meningitidis VaccinoTailandia, Filippine
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GlaxoSmithKlineCompletatoEpatite B | Tetano | Difterite | Haemophilus Influenzae Tipo b | Pertosse a cellule intereIndia
-
GlaxoSmithKlineCompletatoEpatite B | Tetano | Difterite | Haemophilus Influenzae Tipo b | Pertosse a cellule intereArgentina, Nicaragua
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GlaxoSmithKlineCompletatoEpatite B | Tetano | Difterite | Haemophilus Influenzae Tipo b | Pertosse a cellule intere | Difterite-Tetano-Pertosse-Epatite B-Haemophilus Influenzae Tipo b-Neisseria Meningitidis VaccinoTailandia
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GlaxoSmithKlineCompletato
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Sanofi Pasteur, a Sanofi CompanyCompletatoEpatite B | Pertosse | Tetano | Difterite | Haemophilus Influenzae Tipo bFilippine
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Sanofi Pasteur, a Sanofi CompanyCompletatoEpatite B | Pertosse | Tetano | Difterite | Haemophilus Influenzae Tipo bPerù, Messico
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GlaxoSmithKlineCompletato