Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
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)
Studie Overzicht
Toestand
Toestand
Conditie
Conditie
Interventie / Behandeling
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Studietype
Inschrijving (Werkelijk)
Inschrijving
Fase
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Muntinlupa, Filippijnen, 1781
- GSK Investigational Site
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Bangkok, Thailand, 10400
- GSK Investigational Site
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Deelname Criteria
Geschiktheidscriteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Aantal wapens
Wapens en interventies
Deelnemersgroep / ArmDeelnemersgroep / Arm |
Interventie / BehandelingInterventie / Behandeling |
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Experimenteel: 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
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Gecombineerde difterie, tetanus, kinkhoest met hele cellen, hepatitis B, Haemophilus influenzae Type b meningokokken AC-tetanustoxoïde conjugaatvaccin
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Experimenteel: 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
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Gecombineerd difterie-, tetanus-, kinkhoest-, hepatitis-B-vaccin, Haemophilus influenzae type B-conjugaatvaccin
Meningococcal Serogroups A, C, W-135 and Y Vaccine
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Experimenteel: 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
|
Gecombineerde difterie, tetanus, kinkhoest met hele cellen, hepatitis B, Haemophilus influenzae Type b meningokokken AC-tetanustoxoïde conjugaatvaccin
Meningococcal Serogroups A, C, W-135 and Y Vaccine
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Experimenteel: 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
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Gecombineerd difterie-, tetanus-, kinkhoest-, hepatitis-B-vaccin, Haemophilus influenzae type B-conjugaatvaccin
Meningococcal Serogroups A, C, W-135 and Y Vaccine
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Experimenteel: 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
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Gecombineerde difterie, tetanus, kinkhoest met hele cellen, hepatitis B, Haemophilus influenzae Type b meningokokken AC-tetanustoxoïde conjugaatvaccin
|
|
Experimenteel: 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
|
Gecombineerd difterie-, tetanus-, kinkhoest-, hepatitis-B-vaccin, Haemophilus influenzae type B-conjugaatvaccin
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
|
Experimenteel: 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
|
Gecombineerde difterie, tetanus, kinkhoest met hele cellen, hepatitis B, Haemophilus influenzae Type b meningokokken AC-tetanustoxoïde conjugaatvaccin
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
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Experimenteel: 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
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Gecombineerd difterie-, tetanus-, kinkhoest-, hepatitis-B-vaccin, Haemophilus influenzae type B-conjugaatvaccin
Meningococcal Serogroups A, C, W-135 and Y Vaccine
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Wat meet het onderzoek?
Primaire uitkomstmaten
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Subjects With Fever >39°C (Rectal Route).
Tijdsspanne: 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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Secundaire uitkomstmaten
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Tijdsspanne: 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.
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Studie start
Primaire voltooiing (Werkelijk)
Primaire voltooiing
Studie voltooiing (Werkelijk)
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Eerst geplaatst
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update geplaatst
Laatste update ingediend die voldeed aan QC-criteria
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Metabole ziekten
- Ziekten van het zenuwstelsel
- RNA-virusinfecties
- Virusziekten
- Infecties
- Luchtweginfecties
- Ziekten van de luchtwegen
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Neurologische manifestaties
- Lever Ziekten
- Hepatitis, viraal, menselijk
- Hepadnaviridae-infecties
- DNA-virusinfecties
- Bordetella-infecties
- Gram-negatieve bacteriële infecties
- Bacteriële infecties
- Bacteriële infecties en mycosen
- Gram-positieve bacteriële infecties
- Neuromusculaire manifestaties
- Actinomycetales-infecties
- Enterovirusinfecties
- Picornaviridae-infecties
- Orthomyxoviridae-infecties
- Clostridium-infecties
- Hypocalciëmie
- Calciummetabolismestoornissen
- Corynebacterium-infecties
- Hepatitis B
- Kinkhoest
- Hepatitis
- Hepatitis A
- Influenza, mens
- Tetanus
- Difterie
- Tetanie
Andere studie-ID-nummers
Andere studie-ID-nummers
- 103812
- 104171 (Andere identificatie: GSK)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Bestudeer gegevens/documenten
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Statistisch analyseplan
Informatie-ID: 103812Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Gegevensset individuele deelnemers
Informatie-ID: 103812Informatie opmerkingen: 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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Formulier geïnformeerde toestemming
Informatie-ID: 103812Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Leerprotocool
Informatie-ID: 103812Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Specificatie gegevensset
Informatie-ID: 103812Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisch onderzoeksrapport
Informatie-ID: 103812Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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