- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00635128
Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine
27 april 2018 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
415
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
9 år till 13 år (Barn)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Number of Subjects With Any Grade 3 Solicited Local Symptoms
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Antal försökspersoner med eventuella efterfrågade lokala symtom
Tidsram: Under 4-dagars (dagarna 0-3) uppföljningsperioden efter boostervaccination
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Bedömda begärda lokala symtom var smärta, rodnad och svullnad.
Alla = förekomst av symtom oavsett intensitetsgrad.
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Under 4-dagars (dagarna 0-3) uppföljningsperioden efter boostervaccination
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Number of Subjects With Any Solicited General Symptoms
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2008
Primärt slutförande (Faktisk)
8 juli 2008
Avslutad studie (Faktisk)
8 juli 2008
Studieregistreringsdatum
Först inskickad
6 mars 2008
Först inskickad som uppfyllde QC-kriterierna
6 mars 2008
Första postat (Uppskatta)
13 mars 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 juni 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 april 2018
Senast verifierad
1 april 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Luftvägsinfektioner
- Luftvägssjukdomar
- Neuromuskulära sjukdomar
- Infektioner i centrala nervsystemet
- Bordetella infektioner
- Gram-negativa bakteriella infektioner
- Bakteriella infektioner
- Bakteriella infektioner och mykoser
- Gram-positiva bakteriella infektioner
- Actinomycetales infektioner
- Enterovirusinfektioner
- Picornaviridae-infektioner
- Ryggmärgssjukdomar
- Clostridium infektioner
- Corynebacterium-infektioner
- Myelit
- Kikhosta
- Stelkramp
- Difteri
- Polio
Andra studie-ID-nummer
- 110947
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokument
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Datauppsättningsspecifikation
Informationsidentifierare: 110947Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informationsidentifierare: 110947Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Informerat samtycke
Informationsidentifierare: 110947Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättning för individuella deltagare
Informationsidentifierare: 110947Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informationsidentifierare: 110947Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analysplan
Informationsidentifierare: 110947Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annoterad fallrapportformulär
Informationsidentifierare: 110947Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Stelkramp
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Changchun BCHT Biotechnology Co.The First Affiliated Hospital of Yunnan University of Traditional Chinese... och andra samarbetspartnersHar inte rekryterat ännu
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Women and Infants Hospital of Rhode IslandHar inte rekryterat ännuVaccinexponering under graviditet | Tdap - Tetanus, difteri och acellulär pertussisvaccination | Icke-födande partnervaccination under graviditet
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National Institute of Allergy and Infectious Diseases...AvslutadKikhosta | Stelkramp | Difteri | Immunisering mot difteri | Tetanus immunisering | Clostridium Difficile-immuniseringMali
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Children's Mercy Hospital Kansas CityUniversity of Kansas Medical Center; Midwest Cancer AllianceAvslutadKommunikation | Meningit, meningokocker | Tillfredsställelse | Mänskligt papillomvirus | Tdap - Tetanus, difteri och acellulär pertussisvaccinationFörenta staterna
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Sanofi Pasteur, a Sanofi CompanyAvslutadImmunisering av pertussis | Immunisering mot difteri | Tetanus immunisering | Immunisering mot pneumokocker | Hepatit B-vaccination | Poliovaccination | Immunisering av Haemophilus Influenzae Typ B | Immunisering mot rotavirusThailand
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Sanofi Pasteur, a Sanofi CompanyAvslutadImmunisering av pertussis | Immunisering mot difteri | Tetanus immunisering | PoliomyelitvaccinSydafrika
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Sanofi Pasteur, a Sanofi CompanyAvslutadImmunisering av pertussis | Immunisering mot difteri | Tetanus immunisering | Immunisering mot pneumokocker | Hepatit B-vaccination | Haemophilus Influenzae Typ b Immunisering | Poliovaccination | Vaccination mot mässling | Immunisering av röda hund | Varicellavaccination | Immunisering mot påssjukaFörenta staterna, Kanada, Honduras, Puerto Rico
Kliniska prövningar på Boostrix-Polio
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Norwegian Institute of Public HealthAvslutadImmunogenicitet och säkerhetsstudie av en boosterdos (5:e) av difteri-stelkramp-kikhosta-poliovaccinKikhosta | Stelkramp | Difteri | PolioNorge
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GlaxoSmithKlineAvslutadStelkramp | Difteri | Acellulär PertussisBelgien
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GlaxoSmithKlineAvslutadStelkramp | Difteri | Acellulär PertussisMexiko, Chile
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St. Justine's HospitalMinistere de la Sante et des Services SociauxAvslutad
-
Sanofi Pasteur, a Sanofi CompanyAvslutad
-
Sanofi Pasteur, a Sanofi CompanyAvslutad
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University of Prince Edward IslandThe Queen Elizabeth HospitalAvslutad
-
GlaxoSmithKlineAvslutadStelkramp | Difteri | Acellulär PertussisFörenta staterna
-
GlaxoSmithKlineAvslutadStelkramp | Difteri | Acellulär PertussisKina
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GlaxoSmithKlineAvslutadDifteri-stelkramp-acellulära pertussisvaccinerRyska Federationen