- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00326118
Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC With Priorix™, Versus MenC-CRM197 Vaccine With Hiberix™ & Priorix™ in Toddlers Primed With Hib But Not MenC & to Evaluate Persistence up to 5 Years After Vaccination.
The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year of life to subjects primed in infancy with a Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available Hib and MenC vaccines.
In the extension phase, at Years 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Australian Capital Territory
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Garran, Australian Capital Territory, Australië, 2606
- GSK Investigational Site
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New South Wales
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Randwick, New South Wales, Australië, 2031
- GSK Investigational Site
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Westmead, New South Wales, Australië, 2145
- GSK Investigational Site
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Queensland
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Herston, Queensland, Australië, 4029
- GSK Investigational Site
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South Australia
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North Adelaide, South Australia, Australië, 5006
- GSK Investigational Site
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Victoria
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Carlton, Victoria, Australië, 3053
- GSK Investigational Site
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Western Australia
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Perth, Western Australia, Australië
- GSK Investigational Site
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
Primary phase:
- Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 18 months of age at the time of vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents'/guardians knowledge.
- Having completed primary vaccination with two doses of Haemophilus influenzae type b outer membrane protein (Hib-OMP) containing vaccine OR three doses of diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b (DTPa/Hib) containing vaccine at least 6 months before the study start.
Long-term persistence phase:
- Having participated in the vaccination study 106445
Exclusion Criteria:
For the primary vaccination phase:
- Use of any investigational or non-registered product (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.
- Chronic administration (defined as more than 14 days) or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination.
- Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before vaccination and ending 30 days after vaccination.
- Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose.
- Previous administration of a booster dose of Hib vaccine.
- Previous vaccination against measles, mumps, rubella.
- History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases.
- Known exposure to measles, mumps or rubella within 30 days prior to the start of the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- A family history of congenital or hereditary immunodeficiency.
- 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 neurological disorders or more than one episode of febrile convulsion.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Additional exclusion criteria for the long-term persistence phase: to be checked each year.
- Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines.
- History of H. influenzae type b, meningococcal serogroup C diseases.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Meningitec + Hiberix Group
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines.
The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
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One subcutaneous dose at 12-18 months of age
One intramuscular dose at 12-18 months of age.
One intramuscular dose at 12-18 months of age
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Experimenteel: Menitorix Group
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine.
Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
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One subcutaneous dose at 12-18 months of age
One intramuscular dose at 12-18 months of age
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)
Tijdsspanne: 1 month after vaccination
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Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
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1 month after vaccination
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Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer
Tijdsspanne: 1 month after vaccination
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rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.
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1 month after vaccination
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
Tijdsspanne: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
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rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers. Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition. |
Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
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Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
Tijdsspanne: 5 years after vaccination
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rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers.
For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
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5 years after vaccination
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Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
Tijdsspanne: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.
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Titers are given as Geometric Mean Titers (GMTs).
Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement.
For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition.
For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
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Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.
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Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
Tijdsspanne: 5 years after vaccination
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Titers are given as Geometric Mean Titers (GMTs).
Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement.
For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
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5 years after vaccination
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Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
Tijdsspanne: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
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Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
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Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
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Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
Tijdsspanne: 5 years after vaccination
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Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
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5 years after vaccination
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Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Tijdsspanne: Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination
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Concentrations are given as Geometric Mean Concentrations (GMCs).
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Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination
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Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Tijdsspanne: 5 years after vaccination
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Concentrations are given as Geometric Mean Concentrations (GMCs).
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5 years after vaccination
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Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
Tijdsspanne: Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
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Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.
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Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
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Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
Tijdsspanne: Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
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Concentrations given as Geometric Mean Concentrations (GMCs).
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Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
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Number of Subjects Reporting Solicited Local and General Symptoms
Tijdsspanne: Within 4 days (Day 0 -Day 3) after vaccination
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Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite. |
Within 4 days (Day 0 -Day 3) after vaccination
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Number of Subjects Reporting Unsolicited Symptoms
Tijdsspanne: Within 31 days (Day 0 - Day 30) after vaccination
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Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study.
Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
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Within 31 days (Day 0 - Day 30) after vaccination
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Number of Subjects Reporting Serious Adverse Events (SAEs)
Tijdsspanne: Throughout the entire study period (up to year 5)
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A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually. |
Throughout the entire study period (up to year 5)
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- Booy R, Richmond P, Nolan T, McVernon J, Marshall H, Nissen M, Reynolds G, Ziegler JB, Heron L, Lambert S, Caubet M, Mesaros N, Boutriau D. Immediate and longer term immunogenicity of a single dose of the combined haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in primed toddlers 12 to 18 months of age. Pediatr Infect Dis J. 2011 Apr;30(4):340-2. doi: 10.1097/INF.0b013e31820013d2.
- Booy R, Richmond P, Nolan T, McVernon J, Marshall H, Nissen M, Reynolds G, Ziegler JB, Stoney T, Heron L, Lambert S, Mesaros N, Peddiraju K, Miller JM. Three-year antibody persistence and safety after a single dose of combined haemophilus influenzae type b (Hib)-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in Hib-primed toddlers. Pediatr Infect Dis J. 2013 Feb;32(2):169-74. doi: 10.1097/INF.0b013e3182787bff.
- Booy R et al. Immunogenicity and safety of the Hib-MenC-TT conjugate vaccine in Hib-primed toddlers: 3 year follow-up. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.
- Booy R et al. Immunogenicity and safety of the Hib-MenC-TT conjugate vaccine in Hib-primed toddlers: 4 year follow-up. Abstract presented at the Communicable Diseases Network Australia - Communicable Diseases Control Conference 2013, Canberra, Australia, 19-20 March 2013.
- Booy R et al. Prolonged immunogenicity and safety of the HibMenC-TT conjugate vaccine in Hib-Primed toddlers. Abstract presented at the PHAA Communicable Disease Conference. Canberra, Australia, 4-6 April 2011.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 106445
- 106446 (Andere identificatie: GSK)
- 106449 (Andere identificatie: GSK)
- 106450 (Andere identificatie: GSK)
- 106452 (Andere identificatie: GSK)
- 106454 (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: 106445Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Formulier geïnformeerde toestemming
Informatie-ID: 106445Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Leerprotocool
Informatie-ID: 106445Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Specificatie gegevensset
Informatie-ID: 106445Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Gegevensset individuele deelnemers
Informatie-ID: 106445Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisch onderzoeksrapport
Informatie-ID: 106445Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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