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

17 februari 2020 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

798

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 år till 1 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Kombinerad difteri, stelkramp, helcellskikhosta, hepatit B, Haemophilus influenzae Typ b meningokock AC-stelkrampstoxoid konjugatvaccin
Experimentell: 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
Kombinerad difteri, stelkramp, helcellskikhosta, hepatit B-vaccin, Haemophilus influenzae typ b konjugatvaccin
Biologisk: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Experimentell: 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
Kombinerad difteri, stelkramp, helcellskikhosta, hepatit B, Haemophilus influenzae Typ b meningokock AC-stelkrampstoxoid konjugatvaccin
Biologisk: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Experimentell: 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
Kombinerad difteri, stelkramp, helcellskikhosta, hepatit B-vaccin, Haemophilus influenzae typ b konjugatvaccin
Biologisk: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Experimentell: 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
Kombinerad difteri, stelkramp, helcellskikhosta, hepatit B, Haemophilus influenzae Typ b meningokock AC-stelkrampstoxoid konjugatvaccin
Experimentell: 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
Kombinerad difteri, stelkramp, helcellskikhosta, hepatit B-vaccin, Haemophilus influenzae typ b konjugatvaccin
Biologisk: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Experimentell: 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
Kombinerad difteri, stelkramp, helcellskikhosta, hepatit B, Haemophilus influenzae Typ b meningokock AC-stelkrampstoxoid konjugatvaccin
Biologisk: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Experimentell: 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
Kombinerad difteri, stelkramp, helcellskikhosta, hepatit B-vaccin, Haemophilus influenzae typ b konjugatvaccin
Biologisk: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Subjects With Fever >39°C (Rectal Route).
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Tidsram: 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.
Tidsram: 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).
Tidsram: 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).
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GlaxoSmithKline

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 juni 2005

Primärt slutförande (Faktisk)

20 januari 2006

Avslutad studie (Faktisk)

20 januari 2006

Studieregistreringsdatum

Först inskickad

27 september 2005

Först inskickad som uppfyllde QC-kriterierna

27 september 2005

Första postat (Uppskatta)

29 september 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 februari 2020

Senast verifierad

1 februari 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 103812
  • 104171 (Annan identifierare: GSK)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

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

Studiedata/dokument

  1. Statistisk analysplan
    Informationsidentifierare: 103812
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Datauppsättning för individuella deltagare
    Informationsidentifierare: 103812
    Informationskommentarer: 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. Informerat samtycke
    Informationsidentifierare: 103812
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Studieprotokoll
    Informationsidentifierare: 103812
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Datauppsättningsspecifikation
    Informationsidentifierare: 103812
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Klinisk studierapport
    Informationsidentifierare: 103812
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Hepatit B

Kliniska prövningar på Tritanrix-HepB/Hib-MenAC

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