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Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine

21 augustus 2018 bijgewerkt door: GlaxoSmithKline

Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines

The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

450

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Korea, republiek van
      • Ansan, Korea, republiek van, 425-707
        • GSK Investigational Site
      • Bucheon-Si, GyeongGi-do,, Korea, republiek van, 420-767
        • GSK Investigational Site
      • Daejeon, Korea, republiek van, 301-723
        • GSK Investigational Site
      • GyeongSangNam-do, Korea, republiek van, 641-560
        • GSK Investigational Site
      • Gyeonggi-do, Korea, republiek van, 411-706
        • GSK Investigational Site
      • Iksan, Korea, republiek van, 570-711
        • GSK Investigational Site
      • Jeju City, Korea, republiek van, 690-121
        • GSK Investigational Site
      • Jeonju Jeonbuk, Korea, republiek van, 561-712
        • GSK Investigational Site
      • Pusan, Korea, republiek van, 602-739
        • GSK Investigational Site
      • Seoul, Korea, republiek van, 150-719
        • GSK Investigational Site
      • Seoul, Korea, republiek van, 130-702
        • GSK Investigational Site
      • Seoul, Korea, republiek van, 158-710
        • GSK Investigational Site
      • Suwon City, Gyeonggi-do, Korea, republiek van, 442-723
        • GSK Investigational Site
      • Wonju-si Kangwon-do, Korea, republiek van, 220-701
        • GSK Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 jaar tot 1 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • A male or female between, and including, 12-18 months of age at the time of booster vaccination.
  • Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
  • Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
  • Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
  • Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
  • Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
  • Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
  • Acute disease at the time of enrolment.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Synflorix Group
Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Biologisch: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)
Intramuscular injection, administered as a single dose
Andere namen:
  • Pneumococcal vaccine GSK1024850A
Biologisch: GSK Biologicals' Hiberix™
Intramuscular injection, administered as a single dose
Andere namen:
  • Hallo
Actieve vergelijker: Prevenar Group
Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Biologisch: GSK Biologicals' Hiberix™
Intramuscular injection, administered as a single dose
Andere namen:
  • Hallo
Biologisch: Wyeth-Lederle's Prevenar™
Intramuscular injection, administered as a single dose

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects Reporting Grade 3 Adverse Events
Tijdsspanne: Within 31 days (Day 0 - Day 30) after booster vaccination.
Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
Within 31 days (Day 0 - Day 30) after booster vaccination.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects Reporting Solicited Symptoms
Tijdsspanne: Within 4 days (Days 0 to 3) after booster vaccination
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.
Within 4 days (Days 0 to 3) after booster vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Tijdsspanne: Within 31 days (Days 0 to 30) after booster vaccination
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) 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.
Within 31 days (Days 0 to 30) after booster vaccination
Number of Subjects Reporting Serious Adverse Events
Tijdsspanne: After booster vaccination up to study end (Month 0 to Month 1)
Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
After booster vaccination up to study end (Month 0 to Month 1)
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes
Tijdsspanne: One month after booster vaccination (Month 1)

Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL).

Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
One month after booster vaccination (Month 1)
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Tijdsspanne: One month after booster vaccination (Month 1)

Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.

Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
One month after booster vaccination (Month 1)
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Tijdsspanne: One month after booster vaccination (Month 1)
Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.
One month after booster vaccination (Month 1)
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Tijdsspanne: One month after booster vaccination (Month 1)
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
One month after booster vaccination (Month 1)
Concentration of Antibodies Against Protein D (PD)
Tijdsspanne: One month after booster vaccination (Month 1)
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).
One month after booster vaccination (Month 1)
Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)
Tijdsspanne: One month after booster vaccination (Month 1)
Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.
One month after booster vaccination (Month 1)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

GlaxoSmithKline

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

11 juni 2009

Primaire voltooiing (Werkelijk)

11 januari 2010

Studie voltooiing (Werkelijk)

11 januari 2010

Studieregistratiedata

Eerst ingediend

28 mei 2009

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2009

Eerst geplaatst (Schatting)

1 juni 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 september 2018

Laatste update ingediend die voldeed aan QC-criteria

21 augustus 2018

Laatst geverifieerd

1 oktober 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 112933

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Bestudeer gegevens/documenten

  1. Formulier geïnformeerde toestemming
    Informatie-ID: 112933
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  2. Specificatie gegevensset
    Informatie-ID: 112933
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  3. Gegevensset individuele deelnemers
    Informatie-ID: 112933
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  4. Geannoteerd casusrapportformulier
    Informatie-ID: 112933
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  5. Leerprotocool
    Informatie-ID: 112933
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistisch analyseplan
    Informatie-ID: 112933
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinisch onderzoeksrapport
    Informatie-ID: 112933
    Informatie 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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