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Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age

31 december 2019 bijgewerkt door: GlaxoSmithKline

Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

360

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

      • Kolkata, Indië, 700073
        • GSK Investigational Site
      • Ludhiana, Indië, 141 008
        • GSK Investigational Site
      • Pune, Indië
        • GSK Investigational Site
      • Vellore, Indië, 632004
        • 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 maand tot 2 maanden (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
  • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
  • Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
  • Free of any known or suspected health problems (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) other than the study vaccines within 30 days preceding the first dose of the study vaccines, 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 since birth.
  • A family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
  • Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
  • History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of any neurological disorders or seizures.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Babies for which birth weight is < 2 kilogram.

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: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Synflorix & Tritanrix-HebB/Hib Group
Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Intramusculaire injectie, 3 doses
Intramuscular injection, 3 doses
Andere namen:
  • DTPw-HBV/Hib
Actieve vergelijker: Hiberix group & Tritanrix-HebB Group
Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Intramuscular injection, 3 doses
Andere namen:
  • Hallo
Intramuscular injection, 3 doses
Andere namen:
  • DTPw-HBV

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
Tijdsspanne: One month after primary immunization (month 3)

Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL).

Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

One month after primary immunization (month 3)
Concentration of Antibody Against Protein D (PD)
Tijdsspanne: One month after primary immunization (month 3)
Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
One month after primary immunization (month 3)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes
Tijdsspanne: One month after primary immunization (month 3)

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Cross-reactive pneumococcal serotypes included 6A and 19A.

Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.

One month after primary immunization (month 3)
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value
Tijdsspanne: One month after primary immunization

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.

The cut-off was defined as 0.20 microgram per milliliter (µg/mL).

One month after primary immunization
Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes
Tijdsspanne: One month after primary immunization (month 3)
Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.
One month after primary immunization (month 3)
Number of Subjects Seropositive for Pneumococcal Serotypes
Tijdsspanne: One month after primary immunization (month 3)

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.

Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL

One month after primary immunization (month 3)
Number of Subjects Seropositive for Protein D (PD)
Tijdsspanne: One month after primary immunization (month 3)
Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.
One month after primary immunization (month 3)
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
Tijdsspanne: One month after primary immunization (month 3)
Concentration is expressed as GMC in µg/mL.
One month after primary immunization (month 3)
Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)
Tijdsspanne: One month after primary immunization (month 3)
Concentrations were expressed as GMCs in international units per milliliter (IU/mL).
One month after primary immunization (month 3)
Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)
Tijdsspanne: One month after primary immunization (month 3)
Concentration was expressed as GMC in EL.U/mL.
One month after primary immunization (month 3)
Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Tijdsspanne: One month after primary immunization (month 3)
Concentration was expressed as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.
One month after primary immunization (month 3)
Number of Subjects Seropostive for B. Pertussis
Tijdsspanne: One month after primary immunization (month 3)
Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.
One month after primary immunization (month 3)
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)
Tijdsspanne: One month after primary immunization (month 3)

Seroprotection was defined as:

Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL.

One month after primary immunization (month 3)
Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)
Tijdsspanne: One month after primary immunization (month 3)
Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.
One month after primary immunization (month 3)
Number of Subjects With Solicited Local and General Symptoms
Tijdsspanne: Within 4 days (day 0-3) after vaccination
Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.
Within 4 days (day 0-3) after vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Tijdsspanne: Within 31 days (day 0-30) after vaccination

An AE is 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.

Unsolicited AE covers any AE 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

Within 31 days (day 0-30) after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Tijdsspanne: Following first vaccination (Month 0) throughout the entire study period (month 3)
SAEs assessed include 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.
Following first vaccination (Month 0) throughout the entire study period (month 3)

Medewerkers en onderzoekers

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

Sponsor

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.

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 (Werkelijk)

7 maart 2009

Primaire voltooiing (Werkelijk)

13 november 2009

Studie voltooiing (Werkelijk)

13 november 2009

Studieregistratiedata

Eerst ingediend

23 december 2008

Eerst ingediend dat voldeed aan de QC-criteria

23 december 2008

Eerst geplaatst (Schatting)

25 december 2008

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 januari 2020

Laatste update ingediend die voldeed aan QC-criteria

31 december 2019

Laatst geverifieerd

1 december 2019

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

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

JA

Beschrijving IPD-plan

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD-tijdsbestek voor delen

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD-toegangscriteria voor delen

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Bestudeer gegevens/documenten

  1. Leerprotocool
    Informatie-ID: 111188
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  2. Gegevensset individuele deelnemers
    Informatie-ID: 111188
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  3. Geannoteerd casusrapportformulier
    Informatie-ID: 111188
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  4. Klinisch onderzoeksrapport
    Informatie-ID: 111188
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formulier geïnformeerde toestemming
    Informatie-ID: 111188
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  6. Specificatie gegevensset
    Informatie-ID: 111188
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistisch analyseplan
    Informatie-ID: 111188
    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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