Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children

17. februar 2020 oppdatert av: GlaxoSmithKline

Assess Reactogenicity & Safety of a Booster of Either Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix Given (Single-blind) at 15-18 (Philippines)/15-24 Mths (Thailand) & a Dose of Mencevax ACWY at 24-30 Mths (Open Label)

This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child. In the Mencevax ACWY phase at 24-30 months, a dose of Mencevax ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix-HepB/Hib-MenAC. No blood samples will be taken in this safety study.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Subjects previously primed with Tritanrix-HepB/Hib-MenAC will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m), respectively, without or with Mencevax ACWY vaccine at 24 to 30 months of age. Subjects previously primed with Tritanrix-HepB/Hiberix will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m) with Mencevax ACWY vaccine at 24 to 30 months of age.

Studietype

Intervensjonell

Registrering (Faktiske)

798

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Filippinene
      • Muntinlupa, Filippinene, 1781
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • GSK Investigational Site

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

1 år til 1 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (Philippines)/ 15 and 24 months age (Thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
  • Chronic administration (> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral poliovirus vaccine can be given concomitantly.
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study.

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: ACAC_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study ( NCT00317187) are boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
Biologisk: Tritanrix-HepB/Hib-MenAC
Kombinert difteri, stivkrampe, helcellet kikhoste, hepatitt B, Haemophilus influenzae Type b meningokokk AC-tetanus toksoid konjugatvaksine
Eksperimentell: ACHibPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
Biologisk: Tritanrix-HepB/Hiberix
Kombinert difteri, stivkrampe, helcellet pertussis, hepatitt B-vaksine, Haemophilus influenzae type b konjugatvaksine
Biologisk: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Eksperimentell: HibACPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
Biologisk: Tritanrix-HepB/Hib-MenAC
Kombinert difteri, stivkrampe, helcellet kikhoste, hepatitt B, Haemophilus influenzae Type b meningokokk AC-tetanus toksoid konjugatvaksine
Biologisk: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Eksperimentell: HibHibPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
Biologisk: Tritanrix-HepB/Hiberix
Kombinert difteri, stivkrampe, helcellet pertussis, hepatitt B-vaksine, Haemophilus influenzae type b konjugatvaksine
Biologisk: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Eksperimentell: ACAC_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
Biologisk: Tritanrix-HepB/Hib-MenAC
Kombinert difteri, stivkrampe, helcellet kikhoste, hepatitt B, Haemophilus influenzae Type b meningokokk AC-tetanus toksoid konjugatvaksine
Eksperimentell: ACHibPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
Biologisk: Tritanrix-HepB/Hiberix
Kombinert difteri, stivkrampe, helcellet pertussis, hepatitt B-vaksine, Haemophilus influenzae type b konjugatvaksine
Biologisk: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Eksperimentell: HibACPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
Biologisk: Tritanrix-HepB/Hib-MenAC
Kombinert difteri, stivkrampe, helcellet kikhoste, hepatitt B, Haemophilus influenzae Type b meningokokk AC-tetanus toksoid konjugatvaksine
Biologisk: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Eksperimentell: HibHibPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
Biologisk: Tritanrix-HepB/Hiberix
Kombinert difteri, stivkrampe, helcellet pertussis, hepatitt B-vaksine, Haemophilus influenzae type b konjugatvaksine
Biologisk: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Subjects With Fever >39°C (Rectal Route).
Tidsramme: During the 4-day (Day 0-3) follow-up period after booster vaccination
Among solicited general symptoms fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )] was assessed, post vaccination. Grade 3 fever = fever > 39.0 °C.
During the 4-day (Day 0-3) follow-up period after booster vaccination

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Tidsramme: During the 4-day (Day 0-3) follow-up period after vaccination
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
During the 4-day (Day 0-3) follow-up period after vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Tidsramme: During the 4-day (Day 0-3) follow-up period after booster 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 (Day 0-3) follow-up period after booster vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Tidsramme: During the 31-day (Day 0-30) following booster 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.
During the 31-day (Day 0-30) following booster vaccination
Number of Subjects With Serious Adverse Events (SAEs).
Tidsramme: From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination
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.
From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination

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.

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 (Faktiske)

16. juni 2005

Primær fullføring (Faktiske)

20. januar 2006

Studiet fullført (Faktiske)

20. januar 2006

Datoer for studieregistrering

Først innsendt

27. september 2005

Først innsendt som oppfylte QC-kriteriene

27. september 2005

Først lagt ut (Anslag)

29. september 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. februar 2020

Sist bekreftet

1. februar 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 103812
  • 104171 (Annen identifikator: GSK)

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. Statistisk analyseplan
    Informasjonsidentifikator: 103812
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Datasett for individuell deltaker
    Informasjonsidentifikator: 103812
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103812 are summarised with study 104727 on the GSK Clinical Study Register.
  3. Skjema for informert samtykke
    Informasjonsidentifikator: 103812
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Studieprotokoll
    Informasjonsidentifikator: 103812
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Datasettspesifikasjon
    Informasjonsidentifikator: 103812
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Klinisk studierapport
    Informasjonsidentifikator: 103812
    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. .

Abonnere