Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants
27 grudnia 2019 zaktualizowane przez: GlaxoSmithKline
Efficacy, Safety, Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants
This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Szczegółowy opis
Combined diphtheria and tetanus toxoids and acellular pertussis (DTPa) and Hepatitis B (HBV) vaccines are allowed to be co-administered along with Rotarix vaccine/Placebo.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
765
Faza
- Faza 3
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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Aichi, Japonia, 451-0052
- GSK Investigational Site
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Chiba, Japonia, 275-8580
- GSK Investigational Site
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Fukuoka, Japonia, 802-8533
- GSK Investigational Site
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Hiroshima, Japonia, 720-8520
- GSK Investigational Site
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Hiroshima, Japonia, 734-8530
- GSK Investigational Site
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Hiroshima, Japonia, 737-0811
- GSK Investigational Site
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Hiroshima, Japonia, 730-8518
- GSK Investigational Site
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Hiroshima, Japonia, 730-8798
- GSK Investigational Site
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Hokkaido, Japonia, 065-0033
- GSK Investigational Site
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Hokkaido, Japonia, 003-0021
- GSK Investigational Site
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Kagawa, Japonia, 765-8501
- GSK Investigational Site
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Kanagawa, Japonia, 247-8533
- GSK Investigational Site
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Miyagi, Japonia, 983-8520
- GSK Investigational Site
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Miyagi, Japonia, 981-3203
- GSK Investigational Site
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Nagano, Japonia, 386-8610
- GSK Investigational Site
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Nagasaki, Japonia, 856-8562
- GSK Investigational Site
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Niigata, Japonia, 957-8588
- GSK Investigational Site
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Okayama, Japonia, 701-1192
- GSK Investigational Site
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Okayama, Japonia, 701-0204
- GSK Investigational Site
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Osaka, Japonia, 591-8025
- 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
1 miesiąc do 3 miesiące (Dziecko)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Healthy male or female infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parent or guardian of the subject.
- Born between a gestation period of 36 and 42 weeks inclusive.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
- History of use of experimental rotavirus vaccine.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- 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).
- Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Previous confirmed occurrence of RV GE.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
- A family history of congenital or hereditary immunodeficiency.
- Acute disease at the time of enrolment.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
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: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Rotarix Group
Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
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Two-dose oral vaccination.
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Komparator placebo: Placebo Group
Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
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Two-dose oral administration.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
Ramy czasowe: From 2 weeks after Dose 2 up to 2 years of age
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Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
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From 2 weeks after Dose 2 up to 2 years of age
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
Ramy czasowe: From 2 weeks after Dose 2 up to 2 years of age
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A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).
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From 2 weeks after Dose 2 up to 2 years of age
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Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type
Ramy czasowe: From 2 weeks after Dose 2 up to 2 years of age
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Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system). |
From 2 weeks after Dose 2 up to 2 years of age
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Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types
Ramy czasowe: From 2 weeks after Dose 2 up to 2 years of age
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Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system). |
From 2 weeks after Dose 2 up to 2 years of age
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Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains
Ramy czasowe: From 2 weeks after Dose 2 up to 2 years of age
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Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
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From 2 weeks after Dose 2 up to 2 years of age
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Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
Ramy czasowe: From Dose 1 up to 2 years of age
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Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system). |
From Dose 1 up to 2 years of age
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Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration
Ramy czasowe: 2 months after Dose 2
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Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs).
Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL).
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2 months after Dose 2
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Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies
Ramy czasowe: 2 months after Dose 2
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Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e.
prior to the first dose of rotarix) seronegative.
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2 months after Dose 2
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Number of Subjects Reporting Solicited Symptoms
Ramy czasowe: During the 8-day follow-up period after each dose
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Solicited symptoms assessed include cough, diarrhoea, fever, irritability, loss of appetite and vomiting.
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During the 8-day follow-up period after each dose
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Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Ramy czasowe: During the 31-day follow-up period after each dose
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Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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During the 31-day follow-up period after each dose
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Number of Subjects Reporting Serious Adverse Events (SAEs)
Ramy czasowe: Up to 2 years of age
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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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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Up to 2 years of age
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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
- Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.
- Kawamura N, Tokoeda Y, Oshima M, Okahata H, Tsutsumi H, Van Doorn LJ, Muto H, Smolenov I, Suryakiran PV, Han HH. Efficacy, safety and immunogenicity of RIX4414 in Japanese infants during the first two years of life. Vaccine. 2011 Aug 26;29(37):6335-41. doi: 10.1016/j.vaccine.2011.05.017. Epub 2011 Jun 2.
- Kawamura N et al. Efficacy of Human Rotavirus (G1P[8] strain) Vaccine (HRV) RIX4414 in Japanese Infants during the Two-year Efficacy Follow-up Period. Abstract presented at the 114th Annual Meeting of Japan Pediatric Society (JPS). Tokyo, Japan, 12-14 August 2011.
- Kawamura N et al. Efficacy of human rotavirus vaccine RIX4414 in Japanese infants from 2 weeks post dose 2 up to data lock point. Abstract presented at the 28th meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.
- Bergman H, Henschke N, Hungerford D, Pitan F, Ndwandwe D, Cunliffe N, Soares-Weiser K. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev. 2021 Nov 17;11(11):CD008521. doi: 10.1002/14651858.CD008521.pub6.
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)
19 czerwca 2007
Zakończenie podstawowe (Rzeczywisty)
31 marca 2009
Ukończenie studiów (Rzeczywisty)
21 listopada 2009
Daty rejestracji na studia
Pierwszy przesłany
29 maja 2007
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 maja 2007
Pierwszy wysłany (Oszacować)
30 maja 2007
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
2 stycznia 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 grudnia 2019
Ostatnia weryfikacja
1 grudnia 2019
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 107625
- 2015-001543-36 (Numer EudraCT)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Ramy czasowe udostępniania IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Kryteria dostępu do udostępniania IPD
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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- CSR
Badanie danych/dokumentów
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Formularz świadomej zgody
Identyfikator informacji: 107625Komentarze 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: 107625Komentarze 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: 107625Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
-
Protokół badania
Identyfikator informacji: 107625Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
-
Specyfikacja zestawu danych
Identyfikator informacji: 107625Komentarze 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: 107625Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Raport z badania klinicznego
Identyfikator informacji: 107625Komentarze 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 .