Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine
perjantai 27. huhtikuuta 2018 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
415
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Berlin, Saksa, 12627
- GSK Investigational Site
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Berlin, Saksa, 13507
- GSK Investigational Site
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Berlin, Saksa, 13355
- GSK Investigational Site
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Baden-Wuerttemberg
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Ettenheim, Baden-Wuerttemberg, Saksa, 77955
- GSK Investigational Site
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Kehl, Baden-Wuerttemberg, Saksa, 77694
- GSK Investigational Site
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Oberkirch, Baden-Wuerttemberg, Saksa, 77704
- GSK Investigational Site
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Offenburg, Baden-Wuerttemberg, Saksa, 77654
- GSK Investigational Site
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Bayern
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Cham, Bayern, Saksa, 93413
- GSK Investigational Site
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Kaufering, Bayern, Saksa, 86916
- GSK Investigational Site
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Landshut, Bayern, Saksa, 84032
- GSK Investigational Site
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Muenchen, Bayern, Saksa, 80939
- GSK Investigational Site
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Olching, Bayern, Saksa, 82140
- GSK Investigational Site
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Weilheim, Bayern, Saksa, 82362
- GSK Investigational Site
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Hessen
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Eschwege, Hessen, Saksa, 37269
- GSK Investigational Site
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Koenigstein, Hessen, Saksa, 61462
- GSK Investigational Site
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Niedersachsen
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Salzgitter, Niedersachsen, Saksa, 38226
- GSK Investigational Site
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Wolfenbuettel, Niedersachsen, Saksa, 38302
- GSK Investigational Site
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Nordrhein-Westfalen
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Erkrath, Nordrhein-Westfalen, Saksa, 40699
- GSK Investigational Site
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Goch, Nordrhein-Westfalen, Saksa, 47574
- GSK Investigational Site
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Guetersloh, Nordrhein-Westfalen, Saksa, 33332
- GSK Investigational Site
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Heiligenhaus, Nordrhein-Westfalen, Saksa, 42579
- GSK Investigational Site
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Kleve-Materborn, Nordrhein-Westfalen, Saksa, 47533
- GSK Investigational Site
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Krefeld, Nordrhein-Westfalen, Saksa, 47798
- GSK Investigational Site
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Loehne, Nordrhein-Westfalen, Saksa, 32584
- GSK Investigational Site
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Muenster, Nordrhein-Westfalen, Saksa, 48159
- GSK Investigational Site
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Willich, Nordrhein-Westfalen, Saksa, 47877
- GSK Investigational Site
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Rheinland-Pfalz
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Bad Kreuznach, Rheinland-Pfalz, Saksa, 55543
- GSK Investigational Site
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Frankenthal, Rheinland-Pfalz, Saksa, 67227
- GSK Investigational Site
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Mainz, Rheinland-Pfalz, Saksa, 55131
- GSK Investigational Site
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Trier, Rheinland-Pfalz, Saksa, 54294
- GSK Investigational Site
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Worms, Rheinland-Pfalz, Saksa, 67547
- GSK Investigational Site
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Worms, Rheinland-Pfalz, Saksa, 67549
- GSK Investigational Site
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Sachsen
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Dresden, Sachsen, Saksa, 01307
- GSK Investigational Site
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Dresden, Sachsen, Saksa, 01169
- GSK Investigational Site
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Schleswig-Holstein
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Brunsbuettel, Schleswig-Holstein, Saksa, 25541
- GSK Investigational Site
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Flensburg, Schleswig-Holstein, Saksa, 24937
- GSK Investigational Site
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Flensburg, Schleswig-Holstein, Saksa, 24939
- GSK Investigational Site
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Flensburg, Schleswig-Holstein, Saksa, 24943
- GSK Investigational Site
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
9 vuotta - 13 vuotta (Lapsi)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Kokeellinen: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Number of Subjects With Any Grade 3 Solicited Local Symptoms
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Kohteiden lukumäärä, joilla on pyydettyjä paikallisia oireita
Aikaikkuna: 4 päivän (päivät 0-3) seurantajakson aikana tehosterokotuksen jälkeen
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Arvioidut paikalliset oireet olivat kipu, punoitus ja turvotus.
Mikä tahansa = oireen esiintyminen voimakkuusasteesta riippumatta.
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4 päivän (päivät 0-3) seurantajakson aikana tehosterokotuksen jälkeen
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Number of Subjects With Any Solicited General Symptoms
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Perjantai 1. helmikuuta 2008
Ensisijainen valmistuminen (Todellinen)
Tiistai 8. heinäkuuta 2008
Opintojen valmistuminen (Todellinen)
Tiistai 8. heinäkuuta 2008
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 6. maaliskuuta 2008
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 6. maaliskuuta 2008
Ensimmäinen Lähetetty (Arvio)
Torstai 13. maaliskuuta 2008
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 6. kesäkuuta 2018
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 27. huhtikuuta 2018
Viimeksi vahvistettu
Lauantai 1. huhtikuuta 2017
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Keskushermoston sairaudet
- Hermoston sairaudet
- RNA-virusinfektiot
- Virussairaudet
- Infektiot
- Hengitysteiden infektiot
- Hengityselinten sairaudet
- Neuromuskulaariset sairaudet
- Keskushermoston infektiot
- Bordetella-infektiot
- Gram-negatiiviset bakteeri-infektiot
- Bakteeri-infektiot
- Bakteeri-infektiot ja mykoosit
- Gram-positiiviset bakteeri-infektiot
- Actinomycetales -infektiot
- Enterovirusinfektiot
- Picornaviridae-infektiot
- Selkäydinsairaudet
- Clostridium-infektiot
- Corynebacterium-infektiot
- Myeliitti
- Hinkuyskä
- Jäykkäkouristus
- Kurkkumätä
- Poliomyeliitti
Muut tutkimustunnusnumerot
- 110947
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Tutkimustiedot/asiakirjat
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Tietojoukon määritys
Tiedon tunniste: 110947Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Kliinisen tutkimuksen raportti
Tiedon tunniste: 110947Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Ilmoitettu suostumuslomake
Tiedon tunniste: 110947Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Yksittäisen osallistujan tietojoukko
Tiedon tunniste: 110947Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Tutkimuspöytäkirja
Tiedon tunniste: 110947Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Tilastollinen analyysisuunnitelma
Tiedon tunniste: 110947Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Selosteilla varustettu tapausraporttilomake
Tiedon tunniste: 110947Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .