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- Klinische proef 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).
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Muntinlupa, Filippijnen, 1781
- GSK Investigational Site
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Groep 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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Actieve vergelijker: Groep 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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anti-PRP antibody concentration above a protocol defined cut-off value.
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Optreden van gevraagde symptomen
Tijdsspanne: Tijdens de follow-upperiode van 4 dagen na elke dosis
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Tijdens de follow-upperiode van 4 dagen na elke dosis
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anti-HBs antibody concentration
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Over the full course of the study
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Over the full course of the study
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 208108/091
- 208108/092 (Andere identificatie: GSK)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Bestudeer gegevens/documenten
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Specificatie gegevensset
Informatie-ID: 208108/091Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Gegevensset individuele deelnemers
Informatie-ID: 208108/091Informatie opmerkingen: 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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Statistisch analyseplan
Informatie-ID: 208108/091Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Formulier geïnformeerde toestemming
Informatie-ID: 208108/091Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisch onderzoeksrapport
Informatie-ID: 208108/091Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Leerprotocool
Informatie-ID: 208108/091Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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