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Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

25. listopadu 2019 aktualizováno: GlaxoSmithKline

A Dose-range Study to Assess the Safety and Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-month) in Healthy Adult Females (18-25 Years of Age)

Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

383

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Belgie
      • Bruxelles, Belgie, 1070
        • GSK Investigational Site
      • Gent, Belgie, 9000
        • GSK Investigational Site
      • Leuven, Belgie, 3000
        • GSK Investigational Site
      • Liège, Belgie, 4000
        • GSK Investigational Site
      • Roeselare, Belgie, 8800
        • GSK Investigational Site
      • Wilrijk, Belgie, 2610
        • GSK Investigational Site
  • Spojené státy
    • Colorado
      • Aurora, Colorado, Spojené státy, 80045
        • GSK Investigational Site
      • Golden, Colorado, Spojené státy, 80401
        • GSK Investigational Site
    • Rhode Island
      • Kingston, Rhode Island, Spojené státy, 02881
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, Spojené státy, 84109
        • GSK Investigational Site
      • Salt Lake City, Utah, Spojené státy, 84121
        • GSK Investigational Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 25 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  • A woman between, and including, 18 and 25 years of age at the time of the first vaccination
  • Written informed consent from the subject prior to enrolment
  • Subject must be free of obvious health problems
  • Subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners

Exclusion Criteria:

  • Pregnant or breastfeeding
  • A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
  • Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality
  • History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease
  • Previous vaccination against human papillomavirus (HPV)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: HPV-16/18 Group
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Biologický: HPV 16/18 L1 AS04
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
Experimentální: HPV-TETRA A Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Biologický: HPV-16/18/31/45 L1 AS04 Formulation 1
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
Experimentální: HPV-TETRA B Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Biologický: HPV-16/18/31/45 L1 AS04 Formulation 2
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
Experimentální: HPV-TETRA C Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Biologický: HPV-16/18/31/45 L1 AS04 Formulation 3
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
Experimentální: HPV-TETRA D Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Biologický: HPV-16/18/31/45 L1 AS04 Formulation 4
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
Experimentální: HPV-TETRA E Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Biologický: HPV-16/18/31/45 L1 AS04 Formulation 5
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
Experimentální: HPV-TETRA F Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Biologický: HPV-16/18/31/45 L1 AS04 Formulation 6
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
Časové okno: At Month 7
Seroconversion was defined as the appearance of anti-HPV-16 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
At Month 7
Number of Seroconverted Subjects for Anti-HPV-18 at Month 7
Časové okno: At Month 7
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
At Month 7
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7
Časové okno: At Month 7
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.
At Month 7
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7
Časové okno: At Month 7
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
At Month 7

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Seroconverted Subjects for Anti-HPV-16 at Month 2
Časové okno: At Month 2
Seroconversion was defined as the appearance of anti-HPV-16 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 8 EL.U/mL.
At Month 2
Number of Seroconverted Subjects for Anti-HPV-18 at Month 2
Časové okno: At Month 2
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
At Month 2
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2
Časové okno: At Month 2
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
At Month 2
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2
Časové okno: At Month 2
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
At Month 2
Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7
Časové okno: At Month 2 and Month 7
Seroconversion was defined as the appearance of anti-HPV-31 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.
At Month 2 and Month 7
Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7
Časové okno: At Month 2 and Month 7
Seroconversion was defined as the appearance of anti-HPV-45 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.
At Month 2 and Month 7
Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7
Časové okno: At Month 2 and Month 7
Anti-HPV-31 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
At Month 2 and Month 7
Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7
Časové okno: At Month 2 and Month 7
Anti-HPV-45 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
At Month 2 and Month 7
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Časové okno: During the 7 day post-vaccination period following each dose and across doses
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm). All the reported local symptoms are considered related to the vaccination in the study.
During the 7 day post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Časové okno: During the 7 day post-vaccination period following each dose and across doses
Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (>) 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.
During the 7 day post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Časové okno: During the 30-day post-vaccination period
An unsolicited adverse event (AE) was defined as any 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. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination. Grade 3 unsolicited AE = an AE that prevented normal, everyday activities. Related AE = an AE assessed by the investigator as causally related to the study vaccination.
During the 30-day post-vaccination period
Number of Subjects With Any Serious Adverse Events (SAEs)
Časové okno: From Day 0 to Month 7
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
From Day 0 to Month 7
Number of Subjects With Any SAEs During the Extended Safety Follow-up
Časové okno: From Day 0 to Month 12
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
From Day 0 to Month 12
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Časové okno: From Day 0 to Month 12
Outcomes of reported pregnancies were: Healthy baby, Spontaneous abortion, Elective abortion.
From Day 0 to Month 12
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
Časové okno: From Day 0 up to Month 12
NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.
From Day 0 up to Month 12
Number of Subjects Reporting Medically Significant Conditions
Časové okno: From Day 0 up to Month 12
Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.
From Day 0 up to Month 12
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Časové okno: At Month 2 and Month 7
The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological [basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes (white blood cells) = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA]. Abnormal values of a parameter at Months 2 and 7 are defined as below and above the normal ranges, as compared to the baseline status of the same parameter.
At Month 2 and Month 7

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

GlaxoSmithKline

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

4. března 2005

Primární dokončení (Aktuální)

27. března 2006

Dokončení studie (Aktuální)

27. března 2006

Termíny zápisu do studia

První předloženo

3. října 2005

První předloženo, které splnilo kritéria kontroly kvality

3. října 2005

První zveřejněno (Odhad)

4. října 2005

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. prosince 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. listopadu 2019

Naposledy ověřeno

1. listopadu 2019

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 102115
  • 2004-003766-14 (Číslo EudraCT)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

IPD is available via the Clinical Study Data Request site (click on the link provided below).

Časový rámec sdílení IPD

IPD is available via the Clinical Study Data Request site (click on the link provided below).

Kritéria přístupu pro sdílení IPD

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • CSR

Studijní data/dokumenty

  1. Specifikace datové sady
    Identifikátor informace: 102115
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  2. Plán statistické analýzy
    Identifikátor informace: 102115
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protokol studie
    Identifikátor informace: 102115
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  4. Soubor dat jednotlivých účastníků
    Identifikátor informace: 102115
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 102115 are summarised with studies 107919 and 108052 on the GSK Clinical Study Register.
  5. Formulář informovaného souhlasu
    Identifikátor informace: 102115
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  6. Zpráva o klinické studii
    Identifikátor informace: 102115
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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