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Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine

4. august 2016 oppdatert av: GlaxoSmithKline

Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Mixed With Hib Vaccine in Healthy Infants, Followed by a Dose of the Same Vaccine Administered Simultaneously With One Dose of Oral Polio Vaccine (OPV)

This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Fase 3

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

2 måneder til 3 måneder (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study.

  • Healthy male and female subjects in the ≥12 and <16 weeks of life at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parents/guardians of the infant after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

Exclusion Criteria:

The exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn.

  • 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.
  • Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination).
  • Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
  • Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
  • History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • 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 seizures or of any neurological disease at study entry.
  • Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
  • Acute disease at the time of enrolment.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Gruppe A
Biologisk: DTPa-HBV-IPV/Hib (Infanrix hexa™)
Tre doser administrert intramuskulært
Biologisk: OPV
One dose administered orally

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
Tidsramme: One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)
One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)

Sekundære resultatmål

Resultatmål
Tidsramme
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
Tidsramme: Before the first dose ( Month 0 )
Before the first dose ( Month 0 )
Immunogenicity with respect to the components of the study vaccine in terms of antibody titers
Tidsramme: Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).
Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response
Tidsramme: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values
Tidsramme: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Number of subjects with solicited and unsolicited adverse events
Tidsramme: After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall
After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall
Number of subjects with serious adverse events
Tidsramme: During the study period (Month 0 to Month 9)
During the study period (Month 0 to Month 9)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2000

Primær fullføring (Faktiske)

1. april 2001

Studiet fullført (Faktiske)

1. april 2001

Datoer for studieregistrering

Først innsendt

20. oktober 2011

Først innsendt som oppfylte QC-kriteriene

20. oktober 2011

Først lagt ut (Anslag)

24. oktober 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. august 2016

Sist bekreftet

1. august 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 217744/060

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokumenter

  1. Skjema for informert samtykke
    Informasjonsidentifikator: 217744/060
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinisk studierapport
    Informasjonsidentifikator: 217744/060
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Datasett for individuell deltaker
    Informasjonsidentifikator: 217744/060
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datasettspesifikasjon
    Informasjonsidentifikator: 217744/060
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Studieprotokoll
    Informasjonsidentifikator: 217744/060
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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