- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00989612
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)
31 lipca 2018 zaktualizowane przez: GlaxoSmithKline
Immunogenicity and Safety Study of GSK Biologicals' Influenza Candidate Vaccine GSK2340274A
This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
This Protocol Posting has been updated following Protocol amendment 1& 2, October 2009.
The sections impacted are study design and outcome measures
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
100
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Fukuoka, Japonia, 813-8588
- GSK Investigational Site
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Tokyo, Japonia, 204-8585
- GSK Investigational Site
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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
20 lat do 64 lata (Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive.
- Good general health as assessed by medical history and physical examination
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
- Females of non-childbearing potential may be enrolled in the study.
- Female of childbearing potential may be enrolled in the study, if she:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- History of previous administration of a novel [H1N1]v vaccine.
- Previous participation in study NCT00742885.
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
- Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence of an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Diagnosed with cancer, or treatment for cancer within 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
- Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome.
- Administration of any vaccines within 30 days before vaccination or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182, with the exception of seasonal influenza vaccine.
- Administration of any seasonal influenza vaccine within 14 days before vaccination on Day 0, or planned administration within the first vaccination up to blood sampling at Day 42 and within 14 days prior to blood sampling at Day 182.
- Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- Known pregnancy or a positive urine test result prior to the time of first vaccination.
- Lactating or nursing female.
- Excessive underweight (Body Mass Index [BMI] < 18.5) or excessive obesity (BMI >= 30).
- Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
- Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
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: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: GSK2340274A GROUP
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
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Two intramuscular injections on Day 0 and Day 21, respectively
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 0
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Titers are presented as geometric mean titers (GMTs).
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At Day 0
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 21
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Titers are presented as geometric mean titers (GMTs).
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At Day 21
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 42
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Titers are presented as geometric mean titers (GMTs).
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At Day 42
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Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 0
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A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
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At Day 0
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Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 21
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A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
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At Day 21
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Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 42
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A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
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At Day 42
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Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 21
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
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At Day 21
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Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 42
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
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At Day 42
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Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 0
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A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
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At Day 0
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Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 21
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A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
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At Day 21
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Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 42
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A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
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At Day 42
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 21
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The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
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At Day 21
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Day 42
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The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
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At Day 42
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Days 0, 21, 42 and 182
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A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
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At Days 0, 21, 42 and 182
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Days 0, 21, 42 and 182
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Titers are presented as geometric mean titers (GMTs).
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At Days 0, 21, 42 and 182
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Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Days 21, 42 and 182
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
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At Days 21, 42 and 182
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Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Days 0, 21, 42 and 182
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A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
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At Days 0, 21, 42 and 182
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Ramy czasowe: At Days 21, 42 and 182
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The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
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At Days 21, 42 and 182
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Titers for Serum Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Ramy czasowe: At Days 0, 21, 42 and 182
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Titers are presented as geometric mean titers (GMTs).
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At Days 0, 21, 42 and 182
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Number of Seropositive Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Ramy czasowe: At Days 0, 21, 42 and 182
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A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:8.
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At Days 0, 21, 42 and 182
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Number of Seroconverted Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Ramy czasowe: At Days 21, 42 and 182
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A seroconverted subject was defined as a vaccinated subject with a minimum 4-fold increase in post vaccination neutralizing titer.
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At Days 21, 42 and 182
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Ramy czasowe: During a 7-day (Days 0-6) follow-up after each vaccination
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Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
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During a 7-day (Days 0-6) follow-up after each vaccination
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Ramy czasowe: During a 7-day (Days 0-6) follow-up after each vaccination
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Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 temperature = fever > 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
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During a 7-day (Days 0-6) follow-up after each vaccination
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Ramy czasowe: During a 21-day (Days 0-20) follow-up period after the first vaccination and during a 63-day (Days 21-84) follow-up after the second vaccination
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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.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
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During a 21-day (Days 0-20) follow-up period after the first vaccination and during a 63-day (Days 21-84) follow-up after the second vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Ramy czasowe: During the entire study period (Days 0-182)
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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.
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During the entire study period (Days 0-182)
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Number of Subjects With Any Adverse Events of Specific Interest (AESIs).
Ramy czasowe: During the entire study period (Days 0-182)
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An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
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During the entire study period (Days 0-182)
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Number of Days With Any Solicited Local Symptoms
Ramy czasowe: During a 7-day (Days 0-6) follow-up after each vaccination
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Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
The number of days with any solicited local symptom was assessed in subjects who have reported at least once the symptom.
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During a 7-day (Days 0-6) follow-up after each vaccination
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Number of Days With Any Solicited General Symptoms
Ramy czasowe: During a 7-day (Days 0-6) follow-up after each vaccination
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Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
The number of days with any solicited general symptom was assessed in subjects who have reported at least once the symptom.
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During a 7-day (Days 0-6) follow-up after each vaccination
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
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
- Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Li P, Walravens K, Gillard P, Roman F. Characterization and long-term persistence of immune response following two doses of an AS03A-adjuvanted H1N1 influenza vaccine in healthy Japanese adults. Hum Vaccin Immunother. 2012 Feb;8(2):260-6. doi: 10.4161/hv.18469. Epub 2012 Feb 1.
- Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Maeda A, Li P, Gillard P, Roman F. Immunogenicity and safety of a novel AS03(A)-adjuvanted H1N1 2009 pandemic influenza vaccine in adults in Japan. Hum Vaccin. 2010 Nov;6(11):888-93. doi: 10.4161/hv.6.11.12851. Epub 2010 Nov 1.
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 października 2009
Zakończenie podstawowe (Rzeczywisty)
19 kwietnia 2010
Ukończenie studiów (Rzeczywisty)
19 kwietnia 2010
Daty rejestracji na studia
Pierwszy przesłany
1 października 2009
Pierwszy przesłany, który spełnia kryteria kontroli jakości
1 października 2009
Pierwszy wysłany (Oszacować)
5 października 2009
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
16 stycznia 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
31 lipca 2018
Ostatnia weryfikacja
1 kwietnia 2017
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 113519
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
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Raport z badania klinicznego
Identyfikator informacji: 113519Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Plan analizy statystycznej
Identyfikator informacji: 113519Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Formularz świadomej zgody
Identyfikator informacji: 113519Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Indywidualny zestaw danych uczestnika
Identyfikator informacji: 113519Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Protokół badania
Identyfikator informacji: 113519Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Formularz zgłoszenia przypadku z adnotacjami
Identyfikator informacji: 113519Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Specyfikacja zestawu danych
Identyfikator informacji: 113519Komentarze 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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