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Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects

24 maggio 2018 aggiornato da: GlaxoSmithKline

A Randomized, Open Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine Co-administered Intramuscularly With Boostrix® and/or Menactra™ in Healthy Female Subjects Aged 11-18 Years

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase 3b study is designed to evaluate the safety and immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine (580299) as compared to the administration of any of the vaccines alone.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1330

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Mobile, Alabama, Stati Uniti, 36608
        • GSK Investigational Site
    • Arizona
      • Chandler, Arizona, Stati Uniti, 85224
        • GSK Investigational Site
      • Mesa, Arizona, Stati Uniti, 85203
        • GSK Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, Stati Uniti, 72401
        • GSK Investigational Site
      • Little Rock, Arkansas, Stati Uniti, 72205
        • GSK Investigational Site
    • California
      • Fountain Valley, California, Stati Uniti, 92708
        • GSK Investigational Site
      • Fresno, California, Stati Uniti, 93720
        • GSK Investigational Site
      • Long Beach, California, Stati Uniti, 90806
        • GSK Investigational Site
      • Madera, California, Stati Uniti, 93637
        • GSK Investigational Site
      • Rolling Hills Estates, California, Stati Uniti, 90274
        • GSK Investigational Site
    • Colorado
      • Centennial, Colorado, Stati Uniti, 80112
        • GSK Investigational Site
      • Golden, Colorado, Stati Uniti, 80401
        • GSK Investigational Site
      • Thornton, Colorado, Stati Uniti, 80233
        • GSK Investigational Site
    • Florida
      • Cocoa Beach, Florida, Stati Uniti, 32931
        • GSK Investigational Site
      • West Palm Beach, Florida, Stati Uniti, 33409
        • GSK Investigational Site
    • Georgia
      • Marietta, Georgia, Stati Uniti, 30062
        • GSK Investigational Site
    • Kansas
      • Arkansas City, Kansas, Stati Uniti, 67005
        • GSK Investigational Site
      • Lenexa, Kansas, Stati Uniti, 66219
        • GSK Investigational Site
      • Wichita, Kansas, Stati Uniti, 67207
        • GSK Investigational Site
    • Kentucky
      • Bardstown, Kentucky, Stati Uniti, 40004
        • GSK Investigational Site
      • Lexington, Kentucky, Stati Uniti, 40503
        • GSK Investigational Site
      • Louisville, Kentucky, Stati Uniti, 40202
        • GSK Investigational Site
    • Louisiana
      • Bossier City, Louisiana, Stati Uniti, 71111
        • GSK Investigational Site
    • Massachusetts
      • Milford, Massachusetts, Stati Uniti, 01757
        • GSK Investigational Site
    • Michigan
      • Niles, Michigan, Stati Uniti, 49120
        • GSK Investigational Site
      • Stevensville, Michigan, Stati Uniti, 49127
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68134
        • GSK Investigational Site
    • New Jersey
      • Edison, New Jersey, Stati Uniti, 08817
        • GSK Investigational Site
      • Whitehouse Station, New Jersey, Stati Uniti, 08889
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87131
        • GSK Investigational Site
    • New York
      • Rochester, New York, Stati Uniti, 14620
        • GSK Investigational Site
    • North Carolina
      • Cary, North Carolina, Stati Uniti, 27518
        • GSK Investigational Site
      • Laurinburg, North Carolina, Stati Uniti, 28352
        • GSK Investigational Site
      • Raleigh, North Carolina, Stati Uniti, 27609
        • GSK Investigational Site
      • Sylva, North Carolina, Stati Uniti, 28779
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, Stati Uniti, 44308
        • GSK Investigational Site
      • Boardman, Ohio, Stati Uniti, 44512
        • GSK Investigational Site
      • Cleveland, Ohio, Stati Uniti, 44118
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, Stati Uniti, 97216
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Stati Uniti, 16501
        • GSK Investigational Site
      • Greenville, Pennsylvania, Stati Uniti, 16125
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Stati Uniti, 15220
        • GSK Investigational Site
      • Uniontown, Pennsylvania, Stati Uniti, 15401
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29407
        • GSK Investigational Site
      • Charleston, South Carolina, Stati Uniti, 29401
        • GSK Investigational Site
    • Tennessee
      • Gray, Tennessee, Stati Uniti, 37615
        • GSK Investigational Site
    • Texas
      • San Angelo, Texas, Stati Uniti, 76904
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, Stati Uniti, 22015
        • GSK Investigational Site
      • Vienna, Virginia, Stati Uniti, 22180
        • GSK Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 11 anni a 18 anni (Bambino, Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Subjects who the investigator believes that they can, and will, comply with the requirements of the protocol should be enrolled in the study.
  • A female between, and including, 11 and 18 years of age at the time of the first vaccination.
  • Written informed consent obtained from parents/legally acceptable representative of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject is 18 years of age.
  • Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study.
  • Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases, according to the recommended vaccination schedule at the time.
  • Subjects must have a negative urine pregnancy test.
  • Subjects of childbearing potential at the time of study entry are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects also are required to agree to continue such precautions for two months after completion of the vaccination series. Female subjects who reach menarche (began menstruating) during the study and therefore become of child-bearing potential are required to agree to follow the same precautions.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period (up to the Month 12/13 visit), in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine. Administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
  • A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
  • Pregnant or breastfeeding women.
  • Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
  • previous administration of components of the investigational vaccine
  • Administration of a pre-school booster of diphtheria, tetanus, pertussis vaccine within the previous five years.
  • Administration of a diphtheria-tetanus booster or tetanus-diphteria-acellular pertussis (Tdap) vaccine within the previous five years.
  • Previous vaccination against Neisseria meningitidis.
  • Hypersensitivity to latex.
  • Cancer or autoimmune disease under treatment.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine.
  • History of encephalopathy within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
  • Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy.
  • Temperature of >= 105°F within 48 hours of receipt of a prior dose of diphteria- tetanu-pertussis (DTP) vaccine, not due to another identifiable cause.
  • Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP vaccine.
  • Seizures with or without fever within three days of a prior dose of DTP vaccine.
  • Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid within the previous 10 years.
  • Previous history of Guillain-Barré syndrome.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition
  • Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
Biologico: Different formulations of GSK Biologicals' HPV vaccine (580299)
Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
Biologico: Menactra TM
One dose of vaccine administered intramuscularly
Biologico: Boostrix TM
One dose of vaccine administered intramuscularly
Sperimentale: Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
Biologico: Different formulations of GSK Biologicals' HPV vaccine (580299)
Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
Biologico: Menactra TM
One dose of vaccine administered intramuscularly
Biologico: Boostrix TM
One dose of vaccine administered intramuscularly
Sperimentale: Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
Biologico: Different formulations of GSK Biologicals' HPV vaccine (580299)
Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
Biologico: Menactra TM
One dose of vaccine administered intramuscularly
Biologico: Boostrix TM
One dose of vaccine administered intramuscularly
Sperimentale: Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
Biologico: Different formulations of GSK Biologicals' HPV vaccine (580299)
Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
Biologico: Menactra TM
One dose of vaccine administered intramuscularly
Biologico: Boostrix TM
One dose of vaccine administered intramuscularly
Sperimentale: Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
Biologico: Different formulations of GSK Biologicals' HPV vaccine (580299)
Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
Biologico: Menactra TM
One dose of vaccine administered intramuscularly
Sperimentale: Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Biologico: Different formulations of GSK Biologicals' HPV vaccine (580299)
Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)
Lasso di tempo: Before and one month after vaccination with Boostrix
Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)
Before and one month after vaccination with Boostrix
Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Lasso di tempo: Before and one month after vaccination with Boostrix
Concentrations given as Geometric Means Concentrations (GMCs)
Before and one month after vaccination with Boostrix
Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
Lasso di tempo: Before and one month after vaccination with Menactra
Titers given as Geometric Mean Titers (GMTs)
Before and one month after vaccination with Menactra

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
Lasso di tempo: Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)
Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies.
Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)
Lasso di tempo: Before and one month after vaccination with Boostrix
Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL)
Before and one month after vaccination with Boostrix
Concentration of Anti-D and Anti-T Antibodies
Lasso di tempo: Before and one month after vaccination with Boostrix
Concentrations given as Geometric Mean Concentrations (GMCs)
Before and one month after vaccination with Boostrix
Number of Subjects With Booster Response for Anti-D and Anti-T
Lasso di tempo: One month after vaccination with Boostrix

Booster responses for anti-D and anti-T defined as:

  • For initially seronegative subjects (pre-vaccination titer below cut-off: < 0.1 IU/mL): antibody titer at least 4 times the cut-off (post-vaccination titer ≥ 0.4 IU/mL)
  • For initially seropositive subjects (pre-vaccination titer above 0.1 IU/mL): an increase in antibody titer of at least 4 times the pre-vaccination titer
One month after vaccination with Boostrix
Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN
Lasso di tempo: One month after vaccination with Boostrix

Booster responses defined as:

  • For initially seronegative subjects (pre-vaccination titer below cut-off: < 5 EL.U/mL): antibody titers at least 4 times the cut-off,
  • For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,
  • For initially seropositive subjects with pre-vaccination titer ≥ 20 EL.U/mL: an increase in antibody titers of at least two times the pre-vaccination titer
One month after vaccination with Boostrix
Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response
Lasso di tempo: One month after vaccination with Menactra

Vaccine responses for anti-A, C, Y and W-135 defined as:

  • For initially seronegative subjects (pre-vaccination titer below cut-off of 8): antibody titers at least 4 times the cut-off (post vaccination titer ≥ 32)
  • For initially seropositive subjects (pre-vaccination titer above 8): antibody titers at least 4 times the pre-vaccination antibody titer
One month after vaccination with Menactra
Number of Subjects Reporting Solicited Local Symptoms
Lasso di tempo: During the 7-day period following each vaccination
Solicited local symptoms assessed include pain, redness and swelling.
During the 7-day period following each vaccination
Number of Subjects Reporting Solicited General Symptoms
Lasso di tempo: During the 7-day period following each vaccination
Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria
During the 7-day period following each vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Lasso di tempo: During the 30-day period following each vaccination
Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
During the 30-day period following each vaccination
Number of Subjects Reporting Serious Adverse Events
Lasso di tempo: During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
Serious adverse events assessed include medical occurrences that results in death, is 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.
During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)
Lasso di tempo: During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes
During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)
Number of Subjects Reporting Medically Significant Adverse Events (AEs)
Lasso di tempo: During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.
During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

26 settembre 2006

Completamento primario (Effettivo)

22 novembre 2007

Completamento dello studio (Effettivo)

13 febbraio 2008

Date di iscrizione allo studio

Primo inviato

28 agosto 2006

Primo inviato che soddisfa i criteri di controllo qualità

28 agosto 2006

Primo Inserito (Stima)

29 agosto 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 luglio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 maggio 2018

Ultimo verificato

1 novembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 107682

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Dati/documenti di studio

  1. Set di dati del singolo partecipante
    Identificatore informazioni: 107682
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Rapporto di studio clinico
    Identificatore informazioni: 107682
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Modulo di consenso informato
    Identificatore informazioni: 107682
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Protocollo di studio
    Identificatore informazioni: 107682
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Specifica del set di dati
    Identificatore informazioni: 107682
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Piano di analisi statistica
    Identificatore informazioni: 107682
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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