- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00396630
A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator.
One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study.
The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo.
The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
-
-
-
Santo Domingo, Dominicaanse Republiek
- GSK Investigational Site
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Subjects with a live twin living in the same household who is also enrolled in this study.
- Born after a gestation period of ≥32 weeks,
- Discharged from hospital neonatal care stay,
- 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.
- A male or female between, and including, 6 and 14 weeks of age at the time of the first study vaccination.
- 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 subjects.
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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Any clinically significant history of chronic gastrointestinal disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Contact with an immunosuppressed individual.
- 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).
- Chronic administration of immunosuppressants since birth.
- Gastroenteritis within 7 days preceding the first study vaccine administration.
- Documented HIV-positive subject.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Rotarix Group
All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). |
Two-dose oral vaccination.
|
Placebo-vergelijker: Placebo Group
All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). |
Two-dose oral vaccination.
Two-dose oral administration.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.
Tijdsspanne: On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.
|
Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.
|
On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Duration of Human Rotavirus (HRV) Shedding Per Study Group.
Tijdsspanne: From Day 0 up to Week 13.
|
Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen.
|
From Day 0 up to Week 13.
|
Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.
Tijdsspanne: During the entire study period (up to Visit 4, Week 17).
|
Dissimilar amino acid substitutions in the HRV vaccine strain isolated from the twin receiving placebo, when compared to the genetic variation of HRV vaccine strain isolated from the Rotarix vaccine recipients, were counted as genetic variation differences.
|
During the entire study period (up to Visit 4, Week 17).
|
Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.
Tijdsspanne: During the entire study period (up to Visit 4, Week 17).
|
Number of subjects in the Placebo Group with live virus identified in at least one stool sample in case of transmission.
|
During the entire study period (up to Visit 4, Week 17).
|
Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.
Tijdsspanne: At Visit 3 (Week 13).
|
Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose.
|
At Visit 3 (Week 13).
|
Anti-rotavirus IgA Antibody Concentration.
Tijdsspanne: At Visit 3 (Week 13).
|
Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals.
|
At Visit 3 (Week 13).
|
Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.
Tijdsspanne: Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.
|
GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting. RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA). |
Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Tijdsspanne: Within 31 days after any doses.
|
An AE is 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.
|
Within 31 days after any doses.
|
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
Tijdsspanne: Up to Visit 4.
|
A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
Up to Visit 4.
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 106260
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Bestudeer gegevens/documenten
-
Formulier geïnformeerde toestemming
Informatie-ID: 106260Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
-
Specificatie gegevensset
Informatie-ID: 106260Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
-
Leerprotocool
Informatie-ID: 106260Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
-
Gegevensset individuele deelnemers
Informatie-ID: 106260Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistisch analyseplan
Informatie-ID: 106260Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisch onderzoeksrapport
Informatie-ID: 106260Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
-
Geannoteerd casusrapportformulier
Informatie-ID: 106260Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Infecties, rotavirus
-
GlaxoSmithKlineVoltooidRotavirus-infectie | Rotavirus vaccinsVerenigde Staten
-
GlaxoSmithKlineVoltooidInfecties, rotavirus | Rotavirus vaccinsVerenigde Staten, Finland, Duitsland, Taiwan, Spanje, Costa Rica, Korea, republiek van, Japan
-
GlaxoSmithKlineVoltooidInfecties, rotavirus | Rotavirus vaccinsJapan
-
Academisch Medisch Centrum - Universiteit van Amsterdam...University of Padova; Centers for Disease Control and Prevention; Aga Khan University en andere medewerkersVoltooid
-
Merck Sharp & Dohme LLCBeëindigd
-
Sichuan Center for Disease Control and PreventionChina National Biotec Group Company LimitedOnbekend
-
GlaxoSmithKlineVoltooidInfecties, rotavirus | Rotavirus vaccinsFilippijnen
-
GlaxoSmithKlineVoltooidInfecties, rotavirus | Rotavirus vaccinsFilippijnen
Klinische onderzoeken op Rotarix
-
University of VermontInternational Centre for Diarrhoeal Disease Research, Bangladesh; Thrasher Research... en andere medewerkersVoltooidRotavirus-infectie | Vaccinrespons verminderd | Verspreiding van vaccinvirussenBangladesh
-
National Institute of Hygiene and Epidemiology,...Center for Research and Production of Vaccines and Biologicals, VietnamVoltooidMisselijkheid | Diarree | Koorts | Braaksel | PrikkelbaarheidVietnam
-
GlaxoSmithKlineVoltooidInfecties, rotavirusKorea, republiek van
-
Telethon Kids InstituteMenzies School of Health ResearchActief, niet wervendVirale gastro-enteritis door rotavirusAustralië
-
Oxford University Clinical Research Unit, VietnamChildren's Hospital Number 1, Ho Chi Minh City, Vietnam; Hospital for Tropical... en andere medewerkersVoltooidDiarree | RotavirusVietnam
-
University of VermontWashington University School of Medicine; Bill and Melinda Gates Foundation; Stanford... en andere medewerkersVoltooidVerspreiding van vaccinvirussen | Tropische enteropathie | Rotavirus diarreeBangladesh
-
GlaxoSmithKlineVoltooid