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Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects

8 maja 2018 zaktualizowane przez: GlaxoSmithKline

Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY

The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.

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

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

1025

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Filipiny
      • Muntinlupa, Filipiny, 1781
        • GSK Investigational Site
  • Indie
      • Goa, Indie, 403202
        • GSK Investigational Site
      • Indore, Indie, 452001
        • GSK Investigational Site
      • New Delhi, Indie, 110002
        • GSK Investigational Site
      • Pune, Indie, 411 011
        • GSK Investigational Site
  • Tajwan
      • Taipei, Tajwan, 100
        • GSK Investigational Site
      • Tao Yuan County, Tajwan, 333
        • GSK Investigational Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

11 lat do 17 lat (Dziecko)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 11 and 17 years of age at the time of the vaccination.
  • Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge.
  • If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after vaccination.

Exclusion Criteria:

  • 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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
  • Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
  • Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
  • Previous vaccination with tetanus toxoid within the last month.
  • History of meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
  • History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Group A
Subjects of 11-17 years of age who will receive GSK134612
Biologiczny: Szczepionka meningokokowa GSK134612
Jedna dawka domięśniowa
Aktywny komparator: Group B
Subjects of 11-17 years of age who will receive MencevaxTM ACWY
Biologiczny: Mencevax™ ACWY
One subcutaneous dose

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Subjects With Vaccine Response to Meningococcal Antigens
Ramy czasowe: One month post-vaccination (At Month 1)
Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8].
One month post-vaccination (At Month 1)
Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms
Ramy czasowe: During the 4-day (Days 0-3) period after vaccination
General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C).
During the 4-day (Days 0-3) period after vaccination

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values
Ramy czasowe: Prior to (Month 0) and one month after vaccination (Month 1)
Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Prior to (Month 0) and one month after vaccination (Month 1)
Meningococcal rSBA Antibody Titers
Ramy czasowe: Prior to (Month 0) and one month after vaccination (Month 1)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).
Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value
Ramy czasowe: Prior to (Month 0) and one month after vaccination (Month 1)
The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL).
Prior to (Month 0) and one month after vaccination (Month 1)
Anti-TT Antibody Concentrations
Ramy czasowe: Prior to (Month 0) and one month after vaccination (Month 1)
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values
Ramy czasowe: Prior to (Month 0) and one month after vaccination (Month 1)
The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Prior to (Month 0) and one month after vaccination (Month 1)
Anti-meningococcal Polysaccharide Concentrations
Ramy czasowe: Prior to (Month 0) and one month after vaccination (Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Ramy czasowe: During the 4-day (Days 0-3) period after vaccination
Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm).
During the 4-day (Days 0-3) period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Ramy czasowe: During the 4-day (Days 0-3) period after vaccination
Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination.
During the 4-day (Days 0-3) period after vaccination
Number of Subjects With Any Unsolicited Adverse Events
Ramy czasowe: During the 31-day (Days 0-30) post-vaccination period
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) post-vaccination period
Number of Subjects With Any Serious Adverse Events (SAEs)
Ramy czasowe: Up to study end (Month 6)
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.
Up to study end (Month 6)
Number of Subjects With Specific Adverse Events
Ramy czasowe: Up to study end (Month 6)
These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease).
Up to study end (Month 6)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

GlaxoSmithKline

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

2 maja 2007

Zakończenie podstawowe (Rzeczywisty)

16 kwietnia 2008

Ukończenie studiów (Rzeczywisty)

10 września 2008

Daty rejestracji na studia

Pierwszy przesłany

23 kwietnia 2007

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 kwietnia 2007

Pierwszy wysłany (Oszacować)

24 kwietnia 2007

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 czerwca 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 maja 2018

Ostatnia weryfikacja

1 marca 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 109069

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Badanie danych/dokumentów

  1. Plan analizy statystycznej
    Identyfikator informacji: 109069
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formularz zgłoszenia przypadku z adnotacjami
    Identyfikator informacji: 109069
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  3. Specyfikacja zestawu danych
    Identyfikator informacji: 109069
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  4. Protokół badania
    Identyfikator informacji: 109069
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  5. Raport z badania klinicznego
    Identyfikator informacji: 109069
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  6. Indywidualny zestaw danych uczestnika
    Identyfikator informacji: 109069
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  7. Formularz świadomej zgody
    Identyfikator informacji: 109069
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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