Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.
25. november 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
- Biologisk: HPV 16/18 L1 AS04
- Biologisk: HPV-16/18/31/45 L1 AS04 Formulation 1
- Biologisk: HPV-16/18/31/45 L1 AS04 Formulation 2
- Biologisk: HPV-16/18/31/45 L1 AS04 Formulation 3
- Biologisk: HPV-16/18/31/45 L1 AS04 Formulation 4
- Biologisk: HPV-16/18/31/45 L1 AS04 Formulation 5
- Biologisk: HPV-16/18/31/45 L1 AS04 Formulation 6
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
383
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Bruxelles, Belgien, 1070
- GSK Investigational Site
-
Gent, Belgien, 9000
- GSK Investigational Site
-
Leuven, Belgien, 3000
- GSK Investigational Site
-
Liège, Belgien, 4000
- GSK Investigational Site
-
Roeselare, Belgien, 8800
- GSK Investigational Site
-
Wilrijk, Belgien, 2610
- GSK Investigational Site
-
-
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- GSK Investigational Site
-
Golden, Colorado, Forenede Stater, 80401
- GSK Investigational Site
-
-
Rhode Island
-
Kingston, Rhode Island, Forenede Stater, 02881
- GSK Investigational Site
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84109
- GSK Investigational Site
-
Salt Lake City, Utah, Forenede Stater, 84121
- GSK Investigational Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 25 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
|
|
Eksperimentel: 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.
|
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.
|
|
Eksperimentel: 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.
|
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.
|
|
Eksperimentel: 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.
|
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.
|
|
Eksperimentel: 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.
|
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.
|
|
Eksperimentel: 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.
|
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.
|
|
Eksperimentel: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At Month 7
|
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
|
At Month 7
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Seroconverted Subjects for Anti-HPV-16 at Month 2
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
4. marts 2005
Primær færdiggørelse (Faktiske)
27. marts 2006
Studieafslutning (Faktiske)
27. marts 2006
Datoer for studieregistrering
Først indsendt
3. oktober 2005
Først indsendt, der opfyldte QC-kriterier
3. oktober 2005
Først opslået (Skøn)
4. oktober 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 102115
- 2004-003766-14 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
IPD is available via the Clinical Study Data Request site (click on the link provided below).
IPD-delingstidsramme
IPD is available via the Clinical Study Data Request site (click on the link provided below).
IPD-delingsadgangskriterier
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.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Studiedata/dokumenter
-
Datasætspecifikation
Informations-id: 102115Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistisk analyseplan
Informations-id: 102115Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokol
Informations-id: 102115Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Individuelt deltagerdatasæt
Informations-id: 102115Oplysningskommentarer: 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.
-
Formular til informeret samtykke
Informations-id: 102115Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisk undersøgelsesrapport
Informations-id: 102115Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .