- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00635128
Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine
27. april 2018 oppdatert av: GlaxoSmithKline
Evaluation of GSK Biological's dTpa-IPV Booster Vaccine in Children and Adolescents, 5 Years After Previous dTpa-IPV Boosting.
Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
415
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Berlin, Tyskland, 12627
- GSK Investigational Site
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Berlin, Tyskland, 13507
- GSK Investigational Site
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Berlin, Tyskland, 13355
- GSK Investigational Site
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Baden-Wuerttemberg
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Ettenheim, Baden-Wuerttemberg, Tyskland, 77955
- GSK Investigational Site
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Kehl, Baden-Wuerttemberg, Tyskland, 77694
- GSK Investigational Site
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Oberkirch, Baden-Wuerttemberg, Tyskland, 77704
- GSK Investigational Site
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Offenburg, Baden-Wuerttemberg, Tyskland, 77654
- GSK Investigational Site
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Bayern
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Cham, Bayern, Tyskland, 93413
- GSK Investigational Site
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Kaufering, Bayern, Tyskland, 86916
- GSK Investigational Site
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Landshut, Bayern, Tyskland, 84032
- GSK Investigational Site
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Muenchen, Bayern, Tyskland, 80939
- GSK Investigational Site
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Olching, Bayern, Tyskland, 82140
- GSK Investigational Site
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Weilheim, Bayern, Tyskland, 82362
- GSK Investigational Site
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Hessen
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Eschwege, Hessen, Tyskland, 37269
- GSK Investigational Site
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Koenigstein, Hessen, Tyskland, 61462
- GSK Investigational Site
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Niedersachsen
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Salzgitter, Niedersachsen, Tyskland, 38226
- GSK Investigational Site
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Wolfenbuettel, Niedersachsen, Tyskland, 38302
- GSK Investigational Site
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Nordrhein-Westfalen
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Erkrath, Nordrhein-Westfalen, Tyskland, 40699
- GSK Investigational Site
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Goch, Nordrhein-Westfalen, Tyskland, 47574
- GSK Investigational Site
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Guetersloh, Nordrhein-Westfalen, Tyskland, 33332
- GSK Investigational Site
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Heiligenhaus, Nordrhein-Westfalen, Tyskland, 42579
- GSK Investigational Site
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Kleve-Materborn, Nordrhein-Westfalen, Tyskland, 47533
- GSK Investigational Site
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Krefeld, Nordrhein-Westfalen, Tyskland, 47798
- GSK Investigational Site
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Loehne, Nordrhein-Westfalen, Tyskland, 32584
- GSK Investigational Site
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Muenster, Nordrhein-Westfalen, Tyskland, 48159
- GSK Investigational Site
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Willich, Nordrhein-Westfalen, Tyskland, 47877
- GSK Investigational Site
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Rheinland-Pfalz
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Bad Kreuznach, Rheinland-Pfalz, Tyskland, 55543
- GSK Investigational Site
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Frankenthal, Rheinland-Pfalz, Tyskland, 67227
- GSK Investigational Site
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Mainz, Rheinland-Pfalz, Tyskland, 55131
- GSK Investigational Site
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Trier, Rheinland-Pfalz, Tyskland, 54294
- GSK Investigational Site
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Worms, Rheinland-Pfalz, Tyskland, 67547
- GSK Investigational Site
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Worms, Rheinland-Pfalz, Tyskland, 67549
- GSK Investigational Site
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Sachsen
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Dresden, Sachsen, Tyskland, 01307
- GSK Investigational Site
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Dresden, Sachsen, Tyskland, 01169
- GSK Investigational Site
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Schleswig-Holstein
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Brunsbuettel, Schleswig-Holstein, Tyskland, 25541
- GSK Investigational Site
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Flensburg, Schleswig-Holstein, Tyskland, 24937
- GSK Investigational Site
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Flensburg, Schleswig-Holstein, Tyskland, 24939
- GSK Investigational Site
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Flensburg, Schleswig-Holstein, Tyskland, 24943
- GSK Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
9 år til 13 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.
- Written informed consent obtained from both parents/ guardians of the subject; assent from the subject himself/herself should also be requested whenever possible.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to the booster dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during study period.
- 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.
- Previous booster vaccination against tetanus, diphtheria, pertussis, or poliomyelitis since the booster dose received in study 711866/001.
- History of diphtheria, tetanus, pertussis, or poliomyelitis diseases.
- Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine: hypersensitivity reaction to any component of the vaccine, encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine, fever ≥ 40°C within 48 hours of vaccination not due to another identifiable cause, collapse or shock-like state within 48 hours of vaccination
- Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine convulsions with or without fever, occurring within 3 days of vaccination.
- Acute disease at the time of enrolment.
- Pregnant or lactating female.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: BOOSTRIX-POLIO GROUP
Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
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A single booster dose of dTpa-IPV vaccine will be administered to all subjects.
IM administration in the deltoid muscle of the non-dominant arm.
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Eksperimentell: BOOSTRIX + IPV MÉRIEUX GROUP
Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
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A single booster dose of dTpa-IPV vaccine will be administered to all subjects.
IM administration in the deltoid muscle of the non-dominant arm.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of Subjects With Any Grade 3 Solicited Local Symptoms
Tidsramme: During the 4-day (Days 0-3) follow-up period after booster vaccination
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Assessed solicited local symptoms were pain, redness and swelling.
Grade 3 Pain: Pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
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During the 4-day (Days 0-3) follow-up period after booster vaccination
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Antall forsøkspersoner med eventuelle etterspurte lokale symptomer
Tidsramme: I løpet av 4-dagers (dager 0-3) oppfølgingsperiode etter boostervaksinasjon
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Vurderte etterspurte lokale symptomer var smerte, rødhet og hevelse.
Enhver = forekomst av symptom uavhengig av intensitetsgrad.
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I løpet av 4-dagers (dager 0-3) oppfølgingsperiode etter boostervaksinasjon
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Number of Subjects With Any Solicited General Symptoms
Tidsramme: During the 4-day (Days 0-3) follow-up period after booster vaccination
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Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
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During the 4-day (Days 0-3) follow-up period after booster vaccination
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Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids
Tidsramme: Prior to (Month 0) and one month after (Month 1) booster vaccination
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Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA).
Pre-vaccination sera with ELISA concentrations < 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off.
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Prior to (Month 0) and one month after (Month 1) booster vaccination
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Anti-D and Anti-T Antibody Concentrations
Tidsramme: Prior to (Month 0) and one month after (Month 1) booster vaccination
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Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
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Prior to (Month 0) and one month after (Month 1) booster vaccination
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Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Tidsramme: Prior to (Month 0) and one month after (Month 1) booster vaccination
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A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml).
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Prior to (Month 0) and one month after (Month 1) booster vaccination
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Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Tidsramme: Prior to (Month 0) and one month after (Month 1) booster vaccination
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Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
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Prior to (Month 0) and one month after (Month 1) booster vaccination
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Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
Tidsramme: Prior to (Month 0) and one month after (Month 1) booster vaccination
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A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.
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Prior to (Month 0) and one month after (Month 1) booster vaccination
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Anti-Polio 1, 2 and 3 Antibody Titers
Tidsramme: Prior to (Month 0) and one month after (Month 1) booster vaccination
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Antibody titers were presented as geometric mean titers (GMTs).
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Prior to (Month 0) and one month after (Month 1) booster vaccination
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Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Tidsramme: One month after booster vaccination (At Month 1)
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Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL).
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One month after booster vaccination (At Month 1)
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Number of Subjects With Unsolicited Adverse Events (AEs)
Tidsramme: During the 31-day (Days 0-30) follow-up period after booster vaccination
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AEs results are presented for all subjects.
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.
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During the 31-day (Days 0-30) follow-up period after booster vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Tidsramme: During the entire booster period (Month 0 to Month 1)
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Assessed SAEs 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 booster period (Month 0 to Month 1)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Mertsola J et al. The safety of repeated administration of Boostrix™, a reduced-antigen-content dTpa booster. Abstract presented at Excellence In Paediatrics (EIP). Florence, Italy, 3-6 December 2009.
- Knuf M, Baine Y, Bianco V, Boutriau D, Miller JM. Antibody persistence and immune memory 15 months after priming with an investigational tetravalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in toddlers and young children. Hum Vaccin Immunother. 2012 Jul;8(7):866-72. doi: 10.4161/hv.20229. Epub 2012 Apr 9.
- Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009.
- Knuf M et al. The repeated administration of a reduced antigen content diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (dTpa-IPV; BoostrixTM IPV) in adolescents. Abstract presented at IDSA. Philadelphia, USA, 29 October- 1 November 2009.
- Knuf M, Vetter V, Celzo F, Ramakrishnan G, Van Der Meeren O, Jacquet JM. Repeated administration of a reduced-antigen-content diphtheria-tetanus-acellular pertussis and poliomyelitis vaccine (dTpa-IPV; Boostrix IPV). Hum Vaccin. 2010 Jul;6(7):554-61. doi: 10.4161/hv.6.7.11760.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2008
Primær fullføring (Faktiske)
8. juli 2008
Studiet fullført (Faktiske)
8. juli 2008
Datoer for studieregistrering
Først innsendt
6. mars 2008
Først innsendt som oppfylte QC-kriteriene
6. mars 2008
Først lagt ut (Anslag)
13. mars 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juni 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. april 2018
Sist bekreftet
1. april 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Nevromuskulære sykdommer
- Infeksjoner i sentralnervesystemet
- Bordetella-infeksjoner
- Gram-negative bakterielle infeksjoner
- Bakterielle infeksjoner
- Bakterielle infeksjoner og mykoser
- Gram-positive bakterielle infeksjoner
- Actinomycetales infeksjoner
- Enterovirusinfeksjoner
- Picornaviridae-infeksjoner
- Ryggmargssykdommer
- Clostridium-infeksjoner
- Corynebacterium-infeksjoner
- Myelitt
- Kikhoste
- Tetanus
- Difteri
- Poliomyelitt
Andre studie-ID-numre
- 110947
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokumenter
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Datasettspesifikasjon
Informasjonsidentifikator: 110947Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informasjonsidentifikator: 110947Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Skjema for informert samtykke
Informasjonsidentifikator: 110947Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasett for individuell deltaker
Informasjonsidentifikator: 110947Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informasjonsidentifikator: 110947Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analyseplan
Informasjonsidentifikator: 110947Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annotert saksrapportskjema
Informasjonsidentifikator: 110947Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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