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

21. august 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

450

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 1 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)
Intramuscular injection, administered as a single dose
Andre navne:
  • Pneumococcal vaccine GSK1024850A
Biologisk: GSK Biologicals' Hiberix™
Intramuscular injection, administered as a single dose
Andre navne:
  • Hib
Aktiv komparator: 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.
Biologisk: GSK Biologicals' Hiberix™
Intramuscular injection, administered as a single dose
Andre navne:
  • Hib
Biologisk: Wyeth-Lederle's Prevenar™
Intramuscular injection, administered as a single dose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Subjects Reporting Grade 3 Adverse Events
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Subjects Reporting Solicited Symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

11. juni 2009

Primær færdiggørelse (Faktiske)

11. januar 2010

Studieafslutning (Faktiske)

11. januar 2010

Datoer for studieregistrering

Først indsendt

28. maj 2009

Først indsendt, der opfyldte QC-kriterier

28. maj 2009

Først opslået (Skøn)

1. juni 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. august 2018

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 112933

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Studiedata/dokumenter

  1. Formular til informeret samtykke
    Informations-id: 112933
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Datasætspecifikation
    Informations-id: 112933
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individuelt deltagerdatasæt
    Informations-id: 112933
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annoteret sagsbetænkningsformular
    Informations-id: 112933
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Studieprotokol
    Informations-id: 112933
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistisk analyseplan
    Informations-id: 112933
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinisk undersøgelsesrapport
    Informations-id: 112933
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

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Kliniske forsøg med Infektioner, streptokok

Kliniske forsøg med GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)

Søg i lignende forsøg

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Medicinske tilstande

Narkotikainterventioner

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Betingelser

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Narkotikainterventioner

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