Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
1 marca 2017 zaktualizowane przez: GlaxoSmithKline
Persistence of Antibodies After Vaccination With GSK Biologicals' Meningococcal Vaccine GSK134612 in Adolescents and Young Adults
Subjects were previously vaccinated at 11 to 17 years of age.
This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase.
No new subjects will be enrolled.
Przegląd badań
Szczegółowy opis
Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™.
This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase.
No new studies will be enrolled.
The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
697
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
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
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
- Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
- 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 subject's first visit.
- History of meningococcal disease; such cases will be documented.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit.
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
- Subjects who withdrew consent to be contacted for follow-up studies.
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 who received GSK Biologicals' meningococcal vaccine 134612 in the primary vaccination study 109069.
|
A blood sample will be taken yearly at each long-term follow-up visit (i.e.
Year 2 through Year 5) after vaccination during the primary study.
No vaccines are administered in the long-term follow-up study
|
|
Aktywny komparator: Group B
Subjects who received MencevaxTM ACWY in the primary vaccination study 109069.
|
A blood sample will be taken yearly at each long-term follow-up visit (i.e.
Year 2 through Year 5) after vaccination during the primary study.
No vaccines are administered in the long-term follow-up study
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Ramy czasowe: At Month 24 post primary dose
|
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses were performed at the GSK Biologicals' laboratory.
|
At Month 24 post primary dose
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Ramy czasowe: At Month 36 post primary dose
|
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
|
At Month 36 post primary dose
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Ramy czasowe: At Month 48 post primary dose
|
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
|
At Month 48 post primary dose
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Ramy czasowe: At Month 60 post primary dose
|
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
|
At Month 60 post primary dose
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
Ramy czasowe: At Months 24, 36, 48 and 60 post primary dose
|
A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
|
At Months 24, 36, 48 and 60 post primary dose
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
Ramy czasowe: At Months 24, 36, 48 and 60 post primary dose
|
Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128.
Antibody titers were presented as geometric mean titers (GMTs).
The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
|
At Months 24, 36, 48 and 60 post primary dose
|
|
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Ramy czasowe: At Month 24 post primary dose
|
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL).
Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
|
At Month 24 post primary dose
|
|
Antibody Concentrations Against the Vaccine Polysaccharides
Ramy czasowe: At Month 24 post primary dose
|
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL).
Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
|
At Month 24 post primary dose
|
Współpracownicy i badacze
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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
1 września 2009
Zakończenie podstawowe (Rzeczywisty)
1 maja 2013
Ukończenie studiów (Rzeczywisty)
1 maja 2013
Daty rejestracji na studia
Pierwszy przesłany
7 września 2009
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 września 2009
Pierwszy wysłany (Oszacować)
10 września 2009
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
12 kwietnia 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
1 marca 2017
Ostatnia weryfikacja
1 grudnia 2016
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 112148
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