- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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).
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Muntinlupa, Filippinerne, 1781
- GSK Investigational Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Gruppe 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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Aktiv komparator: Gruppe 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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anti-PRP antibody concentration above a protocol defined cut-off value.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Forekomst af opfordrede symptomer
Tidsramme: I løbet af den 4-dages opfølgningsperiode efter hver dosis
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I løbet af den 4-dages opfølgningsperiode efter hver dosis
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anti-HBs antibody concentration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Over the full course of the study
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Over the full course of the study
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 208108/091
- 208108/092 (Anden identifikator: GSK)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Studiedata/dokumenter
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Datasætspecifikation
Informations-id: 208108/091Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Individuelt deltagerdatasæt
Informations-id: 208108/091Oplysningskommentarer: 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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Statistisk analyseplan
Informations-id: 208108/091Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Formular til informeret samtykke
Informations-id: 208108/091Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk undersøgelsesrapport
Informations-id: 208108/091Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokol
Informations-id: 208108/091Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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