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Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects

torstai 26. huhtikuuta 2018 päivittänyt: GlaxoSmithKline

Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007

The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

This open study will have two parallel groups based on the vaccination received in the primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30 months of age. Blood sampling will be done prior to (pre) and one month after (post) the Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum 7 to maximum 16 months per subject.

Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an inconsistency in the earlier version of the protocol posting and to reflect the actual situation.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

168

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

      • Brits, Etelä-Afrikka, 0250
        • GSK Investigational Site
      • Ga-Rankuwa, Etelä-Afrikka, 0208
        • GSK Investigational Site
      • Rooihuiskraal, Etelä-Afrikka, 0145
        • GSK Investigational Site

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

1 vuosi - 1 vuosi (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 15 and 18 months of age at the time of vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Having participated in the primary vaccination study (CPMS N° 759346/007).

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 (defined as more 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.
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007).
  • History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines administered in the study.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures including febrile seizures in infancy.
  • Acute disease at the time of enrolment.
  • Axillary temperature ≥ 37.5°C at the time of vaccination.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period.
  • Anaphylactic reaction following the administration of vaccine in the primary vaccination study.
  • Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: AC primed Group
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months
Active Comparator: AC unprimed Group
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies
Aikaikkuna: At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.
At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
Aikaikkuna: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128.
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Anti-rSBA-MenA, C, W-135 Antibody Titers
Aikaikkuna: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody titers were expressed as geometric mean titers (GMTs).
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
Aikaikkuna: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL).
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Anti-PSA and Anti-PSC Antibody Concentrations
Aikaikkuna: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31
Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values
Aikaikkuna: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody concentrations were ≥ 0.3 µg/mL.
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Anti-PSW Antibody Concentrations
Aikaikkuna: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values
Aikaikkuna: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL).
Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Anti-HBs Antibody Concentrations
Aikaikkuna: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135
Aikaikkuna: At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre < 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination.
At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Number of Subjects With Fever
Aikaikkuna: During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine
Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade.
During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine
Number of Subjects With Solicited Local Symtoms
Aikaikkuna: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade.
During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Number of Subjects With Solicited General Symptoms
Aikaikkuna: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination.
During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Number of Subjects With Unsolicited Adverse Events (AEs)
Aikaikkuna: During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine
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.
During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine
Number of Subjects With Serious Adverse Events (SAEs)
Aikaikkuna: From Months 15-18 and up to Months 25-31 post vaccination
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.
From Months 15-18 and up to Months 25-31 post vaccination

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Julkaisuja ja hyödyllisiä linkkejä

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Opintojen ennätyspäivät

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Opi tärkeimmät päivämäärät

Opiskelun aloitus

Keskiviikko 19. huhtikuuta 2006

Ensisijainen valmistuminen (Todellinen)

Tiistai 1. toukokuuta 2007

Opintojen valmistuminen (Todellinen)

Torstai 17. toukokuuta 2007

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 3. helmikuuta 2006

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 20. huhtikuuta 2006

Ensimmäinen Lähetetty (Arvio)

Maanantai 24. huhtikuuta 2006

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 6. kesäkuuta 2018

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 26. huhtikuuta 2018

Viimeksi vahvistettu

Sunnuntai 1. tammikuuta 2017

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Yksittäisten osallistujien tietojen suunnitelma (IPD)

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IPD-suunnitelman kuvaus

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

Tutkimustiedot/asiakirjat

  1. Tutkimuspöytäkirja
    Tiedon tunniste: 104756
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  2. Tietojoukon määritys
    Tiedon tunniste: 104756
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  3. Tilastollinen analyysisuunnitelma
    Tiedon tunniste: 104756
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  4. Ilmoitettu suostumuslomake
    Tiedon tunniste: 104756
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  5. Yksittäisen osallistujan tietojoukko
    Tiedon tunniste: 104756
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  6. Kliinisen tutkimuksen raportti
    Tiedon tunniste: 104756
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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