Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs
28. juni 2018 opdateret af: GlaxoSmithKline
Evaluation of the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing
Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer.
GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers.
In previous trials this vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities and cervical dysplasia.
In this partially-blind study, GSK Biologicals will evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and an alternative dosing when administered in healthy young females aged 9 to 25 years, as compared to the standard HPV vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
The protocol posting has been updated following a protocol amendment.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
961
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2C8
- GSK Investigational Site
-
-
British Columbia
-
Langley, British Columbia, Canada, V3A 4H9
- GSK Investigational Site
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canada, A1E 2C2
- GSK Investigational Site
-
-
Nova Scotia
-
Truro, Nova Scotia, Canada, B2N 1L2
- GSK Investigational Site
-
-
Quebec
-
Quebec City, Quebec, Canada, G1E 7G9
- GSK Investigational Site
-
-
-
-
-
Berlin, Tyskland, 13086
- GSK Investigational Site
-
Berlin, Tyskland, 13125
- GSK Investigational Site
-
Hamburg, Tyskland, 20246
- GSK Investigational Site
-
Hamburg, Tyskland, 22525
- GSK Investigational Site
-
Hamburg, Tyskland, 22159
- GSK Investigational Site
-
-
Baden-Wuerttemberg
-
Karlsruhe, Baden-Wuerttemberg, Tyskland, 76199
- GSK Investigational Site
-
Kehl, Baden-Wuerttemberg, Tyskland, 77694
- GSK Investigational Site
-
Rheinstetten, Baden-Wuerttemberg, Tyskland, 76287
- GSK Investigational Site
-
Tauberbischofsheim, Baden-Wuerttemberg, Tyskland, 97941
- GSK Investigational Site
-
-
Bayern
-
Muenchen, Bayern, Tyskland, 80637
- GSK Investigational Site
-
Weilheim, Bayern, Tyskland, 82362
- GSK Investigational Site
-
Wuerzburg, Bayern, Tyskland, 97070
- GSK Investigational Site
-
-
Hessen
-
Frankfurt, Hessen, Tyskland, 60439
- GSK Investigational Site
-
-
Niedersachsen
-
Hannover, Niedersachsen, Tyskland, 30625
- GSK Investigational Site
-
Hannover, Niedersachsen, Tyskland, 30657
- GSK Investigational Site
-
Wolfenbuettel, Niedersachsen, Tyskland, 38302
- GSK Investigational Site
-
-
Rheinland-Pfalz
-
Trier, Rheinland-Pfalz, Tyskland, 54290
- GSK Investigational Site
-
-
Sachsen
-
Leipzig, Sachsen, Tyskland, 04109
- GSK Investigational Site
-
-
Schleswig-Holstein
-
Flensburg, Schleswig-Holstein, Tyskland, 24937
- GSK Investigational Site
-
-
Thueringen
-
Nordhausen, Thueringen, Tyskland, 99734
- 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
9 år til 25 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parents can and will comply with the requirements of the protocol should be enrolled in the study.
- A female subject between, and including, 9 and 25 years of age at the time of the first vaccination.
- Written informed consent/assent obtained from the subject prior to enrolment. For subjects above the legal age of consent, written informed consent must be obtained from the subject. For subjects below the legal age of consent, written informed consent from the subject's parents/legally acceptable representative, and written informed assent must be obtained from the subject.
- Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
- Subject must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 24).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Concurrently participating in another clinical study, at any time during the study period (up to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. Planned administration/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.
- Pregnant or breastfeeding female.
- A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
- Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (up to Month 24).
- Previous administration of components of the investigational vaccine.
- Cancer or autoimmune disease under treatment.
- Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to latex.
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period (up to Month 24).
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cervarix 1/Placebo Group
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6.
The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
|
Intramuscular injection, different dosing /schedule
Andre navne:
Intramuscular injection, different dosing /schedule
|
|
Eksperimentel: Cervarix 1/Placebo/Cervarix 1 Group
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
|
Intramuscular injection, different dosing /schedule
Andre navne:
Intramuscular injection, different dosing /schedule
|
|
Eksperimentel: Cervarix 2/Placebo/Cervarix 2 Group
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
|
Intramuscular injection, different dosing /schedule
Andre navne:
Intramuscular injection, different dosing /schedule
|
|
Eksperimentel: Cervarix 2 Group
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6.
The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
|
Intramuscular injection, different dosing /schedule
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Tidsramme: One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).
|
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
|
One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).
|
|
Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms
Tidsramme: Within 7 days (Day 0-6) after vaccination.
|
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the solicited local symptom irrespective of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling larger than (>) 50 millimeters (mm).
|
Within 7 days (Day 0-6) after vaccination.
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Tidsramme: Within 7 days (Day 0-6) after vaccination.
|
Assessed solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature equal or above (≥) 37.5 degrees Celsius (°C), gastrointestinal symptoms, which included nausea, vomiting, diarrhoea and/or abdominal pain, headache, myalgia, rash and urticaria.
Grade 3 symptoms = symptoms that prevented normal activity.
Grade 3 fever = axillary temperature ≥ 39 °C.
Grade 3 urticaria = urticaria distributed on at least 4 body areas.
Related symptom = symptom assessed by the investigator to be causally related to vaccination.
|
Within 7 days (Day 0-6) after vaccination.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .
Tidsramme: At Month 3, 1 month after the second dose of vaccine or placebo
|
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
The analysis was performed on the subjects who were administered a 2-dose vaccination schedule.
|
At Month 3, 1 month after the second dose of vaccine or placebo
|
|
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Tidsramme: At Month 7, 1 month after the last dose of vaccine or placebo.
|
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Groups were stratified into 3 age strata: 9-14, 15-19 and 20-25 years of age at the time of first vaccination.
The 15-19 years age stratum in the group receiving the Cervarix vaccine on a 3-dose vaccination schedule was considered an active comparator.
|
At Month 7, 1 month after the last dose of vaccine or placebo.
|
|
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Tidsramme: At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
|
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
|
At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
|
|
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Tidsramme: At Month 7, 1 month after the last dose of vaccine or placebo.
|
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
|
At Month 7, 1 month after the last dose of vaccine or placebo.
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Tidsramme: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents BAS results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Tidsramme: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.This outcome presents CREA results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Tidsramme: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents EOS results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Tidsramme: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents Hct results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Tidsramme: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents ALT results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Tidsramme: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents LYM results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Tidsramme: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents MON results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Tidsramme: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents NEU results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Tidsramme: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents RBC results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Tidsramme: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents WBC results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Tidsramme: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents PLA results.
|
At Month 7 (M7)
|
|
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)
Tidsramme: At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
|
Seroconversion was defined as the appearance of antibodies (i.e.titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination.
Assay cut-off was defined as ≥ 8 ELISA units per milliliter (EL.U/mL) for HPV-16, and 7 EL.U/mL for HPV-18.
Seronegative subjects are subjects who had an antibody concentration below cut-off value.
Cut-off values were 8 EL.U/mL for antibody concentrations against HPV-16, and 7 EL.U/mL for antibody concentrations against HPV-18.
|
At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
|
|
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Tidsramme: At Month 60 of the safety follow-up phase
|
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
The assay cut-off for Month 60 was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).
|
At Month 60 of the safety follow-up phase
|
|
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)
Tidsramme: At Month 60 of the safety follow-up phase
|
Seroconversion was defined as the appearance of antibodies (i.e.
titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination.
Assay cut-off was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).
Seronegative subjects are subjects who had an antibody concentration below cut-off value.
|
At Month 60 of the safety follow-up phase
|
|
Number of Subjects With Pregnancy Outcomes.
Tidsramme: From Month 0 to Month 48.
|
Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.
|
From Month 0 to Month 48.
|
|
Number of Subjects With Pregnancy Outcomes.
Tidsramme: Throughout the study period, from Month 0 to Month 60.
|
Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.
|
Throughout the study period, from Month 0 to Month 60.
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Tidsramme: Within 30 days (Day 0-29) after vaccination.
|
An unsolicited adverse event (AE) is any adverse event (i.e.
any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Grade 3 = an event that prevented normal activity.
Related = an event assessed by the investigator as causally related to the study vaccination.
|
Within 30 days (Day 0-29) after vaccination.
|
|
Number of Subjects With Medically Significant Conditions (MSCs).
Tidsramme: From Month 0 to Month 7.
|
MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.
The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
|
From Month 0 to Month 7.
|
|
Number of Subjects With Medically Significant Conditions (MSCs).
Tidsramme: From Month 0 to Month 48.
|
MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.
The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
|
From Month 0 to Month 48.
|
|
Number of Subjects With Medically Significant Conditions (MSCs).
Tidsramme: Throughout the study period, from Month 0 to Month 60.
|
MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.
The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
|
Throughout the study period, from Month 0 to Month 60.
|
|
Number of Subjects With New Onset of Autoimmune Diseases (NOADs)
Tidsramme: From Month 0 to Month 7.
|
NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
|
From Month 0 to Month 7.
|
|
Number of Subjects With New Onset of Autoimune Diseases (NOADs)
Tidsramme: From Month 0 to Month 48.
|
NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
|
From Month 0 to Month 48.
|
|
Number of Subjects With New Onset of Autoimmune Diseases (NOADs)
Tidsramme: Throughout the study period, from Month 0 to Month 60.
|
NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
|
Throughout the study period, from Month 0 to Month 60.
|
|
Number of Subjects With New Onset of Chronic Diseases (NOCDs)
Tidsramme: From Month 0 to Month 7.
|
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
|
From Month 0 to Month 7.
|
|
Number of Subjects With New Onset of Chronic Diseases (NOCDs)
Tidsramme: From Month 0 to Month 48.
|
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
|
From Month 0 to Month 48.
|
|
Number of Subjects With New Onset of Chronic Diseases (NOCDs)
Tidsramme: Throughout the study period, from Month 0 to Month 60.
|
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
|
Throughout the study period, from Month 0 to Month 60.
|
|
Number of Subjects With Serious Adverse Events (SAEs).
Tidsramme: From Month 0 to Month 7.
|
SAEs assessed include medical occurrences that result in death, are 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.
|
From Month 0 to Month 7.
|
|
Number of Subjects With Serious Adverse Events (SAEs).
Tidsramme: From Month 0 to Month 48.
|
SAEs assessed include medical occurrences that result in death, are 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.
|
From Month 0 to Month 48.
|
|
Number of Subjects With Serious Adverse Events (SAEs)
Tidsramme: Throughout the study period, from Month 0 to Month 60.
|
SAEs assessed include medical occurrences that result in death, are 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.
|
Throughout the study period, from Month 0 to Month 60.
|
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.
Generelle publikationer
- Romanowski B, Schwarz TF, Ferguson LM, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemanns P, Catteau G, Dobbelaere K, Schuind A, Descamps D. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule: results from a randomized study. Hum Vaccin. 2011 Dec;7(12):1374-86. doi: 10.4161/hv.7.12.18322. Epub 2011 Dec 1.
- Boxus M, Lockman L, Fochesato M, Lorin C, Thomas F, Giannini SL. Antibody avidity measurements in recipients of Cervarix vaccine following a two-dose schedule or a three-dose schedule. Vaccine. 2014 May 30;32(26):3232-6. doi: 10.1016/j.vaccine.2014.04.005. Epub 2014 Apr 13.
- Folschweiller N, Behre U, Dionne M, Durando P, Esposito S, Ferguson L, Ferguson M, Hillemanns P, McNeil SA, Peters K, Ramjattan B, Schwarz TF, Supparatpinyo K, Suryakirian PV, Janssens M, Moris P, Decreux A, Poncelet S, Struyf F. Long-term Cross-reactivity Against Nonvaccine Human Papillomavirus Types 31 and 45 After 2- or 3-Dose Schedules of the AS04-Adjuvanted Human HPV-16/18 Vaccine. J Infect Dis. 2019 May 5;219(11):1799-1803. doi: 10.1093/infdis/jiy743.
- Romanowski B, Schwarz TF, Ferguson L, Peters K, Dionne M, Behre U, Schulze K, Hillemanns P, Suryakiran P, Thomas F, Struyf F. Sustained immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine administered as a two-dose schedule in adolescent girls: Five-year clinical data and modeling predictions from a randomized study. Hum Vaccin Immunother. 2016;12(1):20-9. doi: 10.1080/21645515.2015.1065363. Epub 2015 Jul 15.
- Romanowski B, Schwarz TF, Ferguson LM, Ferguson M, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemanns P, Behre U, Suryakiran P, Thomas F, Struyf F. Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination: results from a randomized study. Hum Vaccin Immunother. 2014;10(5):1155-65. doi: 10.4161/hv.28022. Epub 2014 Feb 27.
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
17. oktober 2007
Primær færdiggørelse (Faktiske)
18. marts 2013
Studieafslutning (Faktiske)
18. marts 2013
Datoer for studieregistrering
Først indsendt
9. oktober 2007
Først indsendt, der opfyldte QC-kriterier
9. oktober 2007
Først opslået (Skøn)
10. oktober 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juni 2018
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 110659
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokumenter
-
Statistisk analyseplan
Informations-id: 110659Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Annoteret sagsbetænkningsformular
Informations-id: 110659Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Individuelt deltagerdatasæt
Informations-id: 110659Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokol
Informations-id: 110659Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasætspecifikation
Informations-id: 110659Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Formular til informeret samtykke
Informations-id: 110659Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisk undersøgelsesrapport
Informations-id: 110659Oplysningskommentarer: 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 .