Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.
25 novembre 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
- Biologico: HPV 16/18 L1 AS04
- Biologico: HPV-16/18/31/45 L1 AS04 Formulation 1
- Biologico: HPV-16/18/31/45 L1 AS04 Formulation 2
- Biologico: HPV-16/18/31/45 L1 AS04 Formulation 3
- Biologico: HPV-16/18/31/45 L1 AS04 Formulation 4
- Biologico: HPV-16/18/31/45 L1 AS04 Formulation 5
- Biologico: HPV-16/18/31/45 L1 AS04 Formulation 6
Tipo di studio
Interventistico
Iscrizione (Effettivo)
383
Fase
- Fase 2
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
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Bruxelles, Belgio, 1070
- GSK Investigational Site
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Gent, Belgio, 9000
- GSK Investigational Site
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Leuven, Belgio, 3000
- GSK Investigational Site
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Liège, Belgio, 4000
- GSK Investigational Site
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Roeselare, Belgio, 8800
- GSK Investigational Site
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Wilrijk, Belgio, 2610
- GSK Investigational Site
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- GSK Investigational Site
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Golden, Colorado, Stati Uniti, 80401
- GSK Investigational Site
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Rhode Island
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Kingston, Rhode Island, Stati Uniti, 02881
- GSK Investigational Site
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Utah
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Salt Lake City, Utah, Stati Uniti, 84109
- GSK Investigational Site
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Salt Lake City, Utah, Stati Uniti, 84121
- GSK Investigational Site
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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 18 anni a 25 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Femmina
Descrizione
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)
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: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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.
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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.
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Sperimentale: 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.
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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.
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Sperimentale: 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.
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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.
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Sperimentale: 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.
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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.
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Sperimentale: 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.
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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.
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Sperimentale: 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.
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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.
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Sperimentale: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
Lasso di tempo: At Month 7
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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).
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At Month 7
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Number of Seroconverted Subjects for Anti-HPV-18 at Month 7
Lasso di tempo: At Month 7
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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.
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At Month 7
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Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7
Lasso di tempo: At Month 7
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Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.
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At Month 7
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Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7
Lasso di tempo: At Month 7
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Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
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At Month 7
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Seroconverted Subjects for Anti-HPV-16 at Month 2
Lasso di tempo: At Month 2
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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.
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At Month 2
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Number of Seroconverted Subjects for Anti-HPV-18 at Month 2
Lasso di tempo: At Month 2
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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.
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At Month 2
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Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2
Lasso di tempo: At Month 2
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Anti-HPV-16 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
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At Month 2
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Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2
Lasso di tempo: At Month 2
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Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
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At Month 2
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Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7
Lasso di tempo: At Month 2 and Month 7
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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.
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At Month 2 and Month 7
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Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7
Lasso di tempo: At Month 2 and Month 7
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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.
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At Month 2 and Month 7
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Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7
Lasso di tempo: At Month 2 and Month 7
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Anti-HPV-31 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
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At Month 2 and Month 7
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Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7
Lasso di tempo: At Month 2 and Month 7
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Anti-HPV-45 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
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At Month 2 and Month 7
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Lasso di tempo: During the 7 day post-vaccination period following each dose and across doses
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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.
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During the 7 day post-vaccination period following each dose and across doses
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Lasso di tempo: During the 7 day post-vaccination period following each dose and across doses
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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.
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During the 7 day post-vaccination period following each dose and across doses
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Lasso di tempo: During the 30-day post-vaccination period
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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.
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During the 30-day post-vaccination period
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Number of Subjects With Any Serious Adverse Events (SAEs)
Lasso di tempo: From Day 0 to Month 7
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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.
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From Day 0 to Month 7
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Number of Subjects With Any SAEs During the Extended Safety Follow-up
Lasso di tempo: From Day 0 to Month 12
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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.
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From Day 0 to Month 12
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Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Lasso di tempo: From Day 0 to Month 12
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Outcomes of reported pregnancies were: Healthy baby, Spontaneous abortion, Elective abortion.
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From Day 0 to Month 12
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Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
Lasso di tempo: From Day 0 up to Month 12
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NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.
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From Day 0 up to Month 12
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Number of Subjects Reporting Medically Significant Conditions
Lasso di tempo: From Day 0 up to Month 12
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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.
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From Day 0 up to Month 12
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Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Lasso di tempo: At Month 2 and Month 7
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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.
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At Month 2 and Month 7
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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.
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 (Effettivo)
4 marzo 2005
Completamento primario (Effettivo)
27 marzo 2006
Completamento dello studio (Effettivo)
27 marzo 2006
Date di iscrizione allo studio
Primo inviato
3 ottobre 2005
Primo inviato che soddisfa i criteri di controllo qualità
3 ottobre 2005
Primo Inserito (Stima)
4 ottobre 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 dicembre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 novembre 2019
Ultimo verificato
1 novembre 2019
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 102115
- 2004-003766-14 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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Descrizione del piano IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below).
Periodo di condivisione IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below).
Criteri di accesso alla condivisione 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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
Dati/documenti di studio
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Specifica del set di dati
Identificatore informazioni: 102115Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Piano di analisi statistica
Identificatore informazioni: 102115Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Protocollo di studio
Identificatore informazioni: 102115Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Set di dati del singolo partecipante
Identificatore informazioni: 102115Commenti informativi: 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.
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Modulo di consenso informato
Identificatore informazioni: 102115Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Rapporto di studio clinico
Identificatore informazioni: 102115Commenti 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 .