- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00228917
Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
17. Februar 2020 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
798
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Muntinlupa, Philippinen, 1781
- GSK Investigational Site
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Bangkok, Thailand, 10400
- GSK Investigational Site
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
1 Jahr bis 1 Jahr (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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
|
Kombinierter Diphtherie-, Tetanus-, Ganzzell-Pertussis-, Hepatitis B-, Haemophilus influenzae Typ B-Meningokokken-AC-Tetanustoxoid-Konjugat-Impfstoff
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Experimental: 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
|
Kombinierter Diphtherie-, Tetanus-, Ganzzell-Pertussis-, Hepatitis-B-Impfstoff, Haemophilus-influenzae-Typ-B-Konjugatimpfstoff
Meningococcal Serogroups A, C, W-135 and Y Vaccine
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Experimental: 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
|
Kombinierter Diphtherie-, Tetanus-, Ganzzell-Pertussis-, Hepatitis B-, Haemophilus influenzae Typ B-Meningokokken-AC-Tetanustoxoid-Konjugat-Impfstoff
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
Experimental: 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
|
Kombinierter Diphtherie-, Tetanus-, Ganzzell-Pertussis-, Hepatitis-B-Impfstoff, Haemophilus-influenzae-Typ-B-Konjugatimpfstoff
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
Experimental: 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
|
Kombinierter Diphtherie-, Tetanus-, Ganzzell-Pertussis-, Hepatitis B-, Haemophilus influenzae Typ B-Meningokokken-AC-Tetanustoxoid-Konjugat-Impfstoff
|
Experimental: 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
|
Kombinierter Diphtherie-, Tetanus-, Ganzzell-Pertussis-, Hepatitis-B-Impfstoff, Haemophilus-influenzae-Typ-B-Konjugatimpfstoff
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
Experimental: 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
|
Kombinierter Diphtherie-, Tetanus-, Ganzzell-Pertussis-, Hepatitis B-, Haemophilus influenzae Typ B-Meningokokken-AC-Tetanustoxoid-Konjugat-Impfstoff
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
Experimental: 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
|
Kombinierter Diphtherie-, Tetanus-, Ganzzell-Pertussis-, Hepatitis-B-Impfstoff, Haemophilus-influenzae-Typ-B-Konjugatimpfstoff
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Subjects With Fever >39°C (Rectal Route).
Zeitfenster: During the 4-day (Day 0-3) follow-up period after booster vaccination
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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.
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During the 4-day (Day 0-3) follow-up period after booster vaccination
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Zeitfenster: During the 4-day (Day 0-3) follow-up period after vaccination
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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.
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During the 4-day (Day 0-3) follow-up period after vaccination
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Zeitfenster: During the 4-day (Day 0-3) follow-up period after booster vaccination
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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.
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During the 4-day (Day 0-3) follow-up period after booster vaccination
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Number of Subjects With Any Unsolicited Adverse Events (AEs).
Zeitfenster: During the 31-day (Day 0-30) following booster vaccination
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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.
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During the 31-day (Day 0-30) following booster vaccination
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Number of Subjects With Serious Adverse Events (SAEs).
Zeitfenster: From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination
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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.
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From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
16. Juni 2005
Primärer Abschluss (Tatsächlich)
20. Januar 2006
Studienabschluss (Tatsächlich)
20. Januar 2006
Studienanmeldedaten
Zuerst eingereicht
27. September 2005
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. September 2005
Zuerst gepostet (Schätzen)
29. September 2005
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. Februar 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. Februar 2020
Zuletzt verifiziert
1. Februar 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Stoffwechselerkrankungen
- Erkrankungen des Nervensystems
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Infektionen der Atemwege
- Erkrankungen der Atemwege
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Neurologische Manifestationen
- Leberkrankheiten
- Hepatitis, viral, menschlich
- Hepadnaviridae-Infektionen
- DNA-Virusinfektionen
- Bordetella-Infektionen
- Gramnegative bakterielle Infektionen
- Bakterielle Infektionen
- Bakterielle Infektionen und Mykosen
- Grampositive bakterielle Infektionen
- Neuromuskuläre Manifestationen
- Actinomycetales-Infektionen
- Enterovirus-Infektionen
- Picornaviridae-Infektionen
- Orthomyxoviridae-Infektionen
- Clostridium-Infektionen
- Hypokalzämie
- Störungen des Kalziumstoffwechsels
- Corynebacterium-Infektionen
- Hepatitis B
- Keuchhusten
- Hepatitis
- Hepatitis A
- Grippe, Mensch
- Tetanus
- Diphtherie
- Tetanie
Andere Studien-ID-Nummern
- 103812
- 104171 (Andere Kennung: GSK)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Ja
Beschreibung des IPD-Plans
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiendaten/Dokumente
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Statistischer Analyseplan
Informationskennung: 103812Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einzelner Teilnehmerdatensatz
Informationskennung: 103812Informationskommentare: 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.
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Einwilligungserklärung
Informationskennung: 103812Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Studienprotokoll
Informationskennung: 103812Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Datensatzspezifikation
Informationskennung: 103812Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Klinischer Studienbericht
Informationskennung: 103812Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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