- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00480324
Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants
Efficacy, Safety, Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Aichi, Japan, 451-0052
- GSK Investigational Site
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Chiba, Japan, 275-8580
- GSK Investigational Site
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Fukuoka, Japan, 802-8533
- GSK Investigational Site
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Hiroshima, Japan, 720-8520
- GSK Investigational Site
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Hiroshima, Japan, 734-8530
- GSK Investigational Site
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Hiroshima, Japan, 737-0811
- GSK Investigational Site
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Hiroshima, Japan, 730-8518
- GSK Investigational Site
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Hiroshima, Japan, 730-8798
- GSK Investigational Site
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Hokkaido, Japan, 065-0033
- GSK Investigational Site
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Hokkaido, Japan, 003-0021
- GSK Investigational Site
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Kagawa, Japan, 765-8501
- GSK Investigational Site
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Kanagawa, Japan, 247-8533
- GSK Investigational Site
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Miyagi, Japan, 983-8520
- GSK Investigational Site
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Miyagi, Japan, 981-3203
- GSK Investigational Site
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Nagano, Japan, 386-8610
- GSK Investigational Site
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Nagasaki, Japan, 856-8562
- GSK Investigational Site
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Niigata, Japan, 957-8588
- GSK Investigational Site
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Okayama, Japan, 701-1192
- GSK Investigational Site
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Okayama, Japan, 701-0204
- GSK Investigational Site
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Osaka, Japan, 591-8025
- GSK Investigational Site
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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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Placebo komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
Tidsramme: 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
Tidsramme: 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
Tidsramme: From 2 weeks after Dose 2 up to 2 years of age
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 107625
- 2015-001543-36 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Studiedata/dokumenter
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Skjema for informert samtykke
Informasjonsidentifikator: 107625Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analyseplan
Informasjonsidentifikator: 107625Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasett for individuell deltaker
Informasjonsidentifikator: 107625Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informasjonsidentifikator: 107625Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasettspesifikasjon
Informasjonsidentifikator: 107625Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annotert saksrapportskjema
Informasjonsidentifikator: 107625Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informasjonsidentifikator: 107625Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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