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Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls

Primary Purpose

Infections, Papillomavirus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

GSK Biologicals' HPV vaccine 580299

About this trial

This is an interventional prevention trial for Infections, Papillomavirus focused on measuring HPV infection, Human Papillomavirus, Cervical cancer, HPV-16, HPV-18, vaccine

Eligibility Criteria

9 Years - 25 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Subjects who the investigator believes can and will comply with the requirements of the protocol or/ and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
A female between, and including, 9 and 25 years of age at the time of the first vaccination
Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form
Healthy subjects
Female subjects of non-childbearing potential may be enrolled in the study
Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire vaccination period and up to two months after the last study vaccine dose

Exclusion Criteria:

Pregnant or breastfeeding
A female planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose
Previous vaccination against HPV or planned administration of another HPV vaccine during the study
Child in care. A child in care is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines
Cancer or autoimmune disease under treatment
Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
Previous administration of MPL or AS04 adjuvant.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period
Any confirmed or suspected immunosuppressive or immunodeficient condition
Family history of congenital or hereditary immunodeficiency
Major congenital defects or serious chronic illness
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine
Acute disease and/or fever at the time of enrolment

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Cervarix 1 Group

Cervarix 2 Group

Cervarix 3 Group

Arm Description

Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.

Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.

Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.

Outcomes

Primary Outcome Measures

Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7

Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 concentrations ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration lower than (<) 8/7 EL.U/mL, respectively.

Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7

Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.

Secondary Outcome Measures

Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36

Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL [applicable for Day 0, Month 7 and Month 12 time points] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL [applicable for Month 18, Month 24 and Month 36 time points]) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (<) the aforementioned cut-offs. Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards.

Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36

Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.

Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group

Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL [applicable for Day 0 and Month 13 time points] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL [applicable for Month 18, Month 24 and Month 36 time points]) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (<) the aforementioned cut-offs. Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards.

Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group

Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.

Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group

Antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group

Antibody titers were expressed as GMTs. The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects per study group.

Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects

The CMI response represents the measure of the cytokines production [i.e. interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and the cluster of differentiation 40 Ligand (CD40L)] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16. The frequency was presented as number of cytokine-positive cluster of differentiation (CD)4 i.e. CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.

Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects

The CMI response represents the measure of the cytokines production [IL-2, IFN-γ, TNF-α, and CD40L] by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < the cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.

Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects

The CMI response represents the measure of the cytokines production (IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-16. The frequency was presented as a number of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects

The CMI response represents the measure of the cytokines production (i.e. IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects

The CMI response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.

Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects

The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.

Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects

The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects

The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

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).

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any fever = axillary temperature ≥ 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.

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any = any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = unsolicited AE preventing normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.

Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)

pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

Number of Subjects With Medically Significant Conditions (MSCs)

MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs)

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 = any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as causally related to the study vaccination.

Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies

Outcomes of reported pregnancies were: Ectopic pregnancy, Elective termination NO apparent congenital anomaly (ACA), Live Infant NO ACA, Stillbirth NO ACA.

Number of Subjects Completing the Vaccination Course

The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study.

Full Information

NCT ID

NCT01381575

First Posted

June 17, 2011

Last Updated

May 19, 2020

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01381575

Brief Title

Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls

Official Title

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

June 29, 2011 (Actual)

Primary Completion Date

June 28, 2012 (Actual)

Study Completion Date

November 13, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule (0,1,6 months) in 15-25 year old females.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Papillomavirus

Keywords

HPV infection, Human Papillomavirus, Cervical cancer, HPV-16, HPV-18, vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1447 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cervarix 1 Group

Arm Type

Experimental

Arm Description

Arm Title

Cervarix 2 Group

Arm Type

Active Comparator

Arm Description

Arm Title

Cervarix 3 Group

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

GSK Biologicals' HPV vaccine 580299

Other Intervention Name(s)

Cervarix

Intervention Description

Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.

Primary Outcome Measure Information:

Title

Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7

Description

Time Frame

At Month 7 (i.e. one month after the last dose of study vaccine)

Title

Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7

Description

Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.

Time Frame

At Month 7 (i.e. one month after the last dose of study vaccine)

Secondary Outcome Measure Information:

Title

Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36

Description

Time Frame

At Day 0 and at Months 7, 12, 18, 24 and 36

Title

Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36

Description

Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.

Time Frame

At Day 0 and at Months 7, 12, 18, 24 and 36

Title

Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group

Description

Time Frame

At Day 0 and at Months 13, 18, 24 and 36

Title

Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group

Description

Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.

Time Frame

At Day 0 and at Months 13, 18, 24 and 36

Title

Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group

Description

Time Frame

At Day 0 and at Months 13, 18, 24 and 36

Title

Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group

Description

Antibody titers were expressed as GMTs. The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects per study group.

Time Frame

At Day 0 and at Months 7, 12, 18, 24 and 36

Title

Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects

Description

Time Frame

At Day 0 and at Months 7, 12, 24 and 36

Title

Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects

Description

Time Frame

At Day 0 and at Months 7, 12, 24 and 36

Title

Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects

Description

Time Frame

At Day 0 and at Months 13, 18 and 36

Title

Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects

Description

Time Frame

At Day 0 and at Months 13, 18 and 36

Title

Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects

Description

Time Frame

At Day 0 and at Months 7, 12, 24 and 36

Title

Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects

Description

Time Frame

At Day 0 and at Months 7, 12, 24 and 36

Title

Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects

Description

Time Frame

At Day 0 and at Months 13, 18 and 36

Title

Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects

Description

The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Time Frame

At Day 0 and at Months 13, 18 and 36

Title

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Description

Time Frame

During the 7-day period (Days 0-6) after each vaccine dose and across doses

Title

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Description

Time Frame

During the 7-day period (Days 0-6) after each vaccine dose and across doses

Title

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Description

Time Frame

During the 30 day (Days 0-29) post-vaccination period

Title

Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)

Description

pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

Time Frame

From Day 0 up to Month 13 (for Cervarix 1 Group and Cervarix 2 Group) and from Day 0 up to Month 18 (for Cervarix 3 Group)

Title

Number of Subjects With Medically Significant Conditions (MSCs)

Description

Time Frame

From Day 0 up to Month 36 (throughout the study period)

Title

Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs)

Description

Time Frame

From Day 0 up to Month 36 (throughout the study period)

Title

Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies

Description

Outcomes of reported pregnancies were: Ectopic pregnancy, Elective termination NO apparent congenital anomaly (ACA), Live Infant NO ACA, Stillbirth NO ACA.

Time Frame

From Day 0 up to Month 36 (throughout the study period)

Title

Number of Subjects Completing the Vaccination Course

Description

The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study.

Time Frame

From Day 0 up to Month 13

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol or/ and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol A female between, and including, 9 and 25 years of age at the time of the first vaccination Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form Healthy subjects Female subjects of non-childbearing potential may be enrolled in the study Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire vaccination period and up to two months after the last study vaccine dose Exclusion Criteria: Pregnant or breastfeeding A female planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose Previous vaccination against HPV or planned administration of another HPV vaccine during the study Child in care. A child in care is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian. Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines Cancer or autoimmune disease under treatment Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product Previous administration of MPL or AS04 adjuvant. Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period Any confirmed or suspected immunosuppressive or immunodeficient condition Family history of congenital or hereditary immunodeficiency Major congenital defects or serious chronic illness Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine Acute disease and/or fever at the time of enrolment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Coquitlam

State/Province

British Columbia

ZIP/Postal Code

V3K 3P4

Country

Canada

Facility Name

GSK Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

Facility Name

GSK Investigational Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 1H5

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

GSK Investigational Site

City

Woodstock

State/Province

Ontario

ZIP/Postal Code

N4S 5P5

Country

Canada

Facility Name

GSK Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 2G2

Country

Canada

Facility Name

GSK Investigational Site

City

Freiburg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

79106

Country

Germany

Facility Name

GSK Investigational Site

City

Kehl

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

77694

Country

Germany

Facility Name

GSK Investigational Site

City

Schoenau Am Koenigssee

State/Province

Bayern

ZIP/Postal Code

83471

Country

Germany

Facility Name

GSK Investigational Site

City

Wuerzburg

State/Province

Bayern

ZIP/Postal Code

97070

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30657

Country

Germany

Facility Name

GSK Investigational Site

City

Wolfenbuettel

State/Province

Niedersachsen

ZIP/Postal Code

38302

Country

Germany

Facility Name

GSK Investigational Site

City

Wolfsburg

State/Province

Niedersachsen

ZIP/Postal Code

38440

Country

Germany

Facility Name

GSK Investigational Site

City

Kleve-Materborn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

47533

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55116

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

GSK Investigational Site

City

Trier

State/Province

Rheinland-Pfalz

ZIP/Postal Code

54290

Country

Germany

Facility Name

GSK Investigational Site

City

Flensburg

State/Province

Schleswig-Holstein

ZIP/Postal Code

24937

Country

Germany

Facility Name

GSK Investigational Site

City

Weimar

State/Province

Thueringen

ZIP/Postal Code

99423

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13055

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22159

Country

Germany

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20122

Country

Italy

Facility Name

GSK Investigational Site

City

Cuneo

State/Province

Piemonte

ZIP/Postal Code

12100

Country

Italy

Facility Name

GSK Investigational Site

City

Cagliari

State/Province

Sardegna

ZIP/Postal Code

09127

Country

Italy

Facility Name

GSK Investigational Site

City

Ragusa

State/Province

Sicilia

ZIP/Postal Code

97100

Country

Italy

Facility Name

GSK Investigational Site

City

Padova

State/Province

Veneto

ZIP/Postal Code

35128

Country

Italy

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

GSK Investigational Site

City

Chiangmai

ZIP/Postal Code

50200

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

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 Sharing URL

https://www.clinicalstudydatarequest.com/Posting.aspx?ID=4511

Citations:

PubMed Identifier

28591778

Citation

Huang LM, Puthanakit T, Cheng-Hsun C, Ren-Bin T, Schwarz T, Pellegrino A, Esposito S, Frenette L, McNeil S, Durando P, Rheault P, Giaquinto C, Horn M, Petry KU, Peters K, Azhar T, Hillemanns P, De Simoni S, Friel D, Pemmaraju S, Hezareh M, Thomas F, Descamps D, Folschweiller N, Struyf F. Sustained Immunogenicity of 2-dose Human Papillomavirus 16/18 AS04-adjuvanted Vaccine Schedules in Girls Aged 9-14 Years: A Randomized Trial. J Infect Dis. 2017 Jun 1;215(11):1711-1719. doi: 10.1093/infdis/jix154.

Results Reference

background

PubMed Identifier

26908726

Citation

Puthanakit T, Huang LM, Chiu CH, Tang RB, Schwarz TF, Esposito S, Frenette L, Giaquinto C, McNeil S, Rheault P, Durando P, Horn M, Klar M, Poncelet S, De Simoni S, Friel D, De Muynck B, Suryakiran PV, Hezareh M, Descamps D, Thomas F, Struyf F. Randomized Open Trial Comparing 2-Dose Regimens of the Human Papillomavirus 16/18 AS04-Adjuvanted Vaccine in Girls Aged 9-14 Years Versus a 3-Dose Regimen in Women Aged 15-25 Years. J Infect Dis. 2016 Aug 15;214(4):525-36. doi: 10.1093/infdis/jiw036. Epub 2016 Feb 3.

Results Reference

background

PubMed Identifier

28934440

Citation

Stevenson L, Huang LM, Berlaimont V, Folschweiller N. Reply to Poddighe. J Infect Dis. 2017 Sep 15;216(6):783-785. doi: 10.1093/infdis/jix365. No abstract available.

Results Reference

background

PubMed Identifier

30715452

Citation

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.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114700

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114700

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114700

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114700

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114700

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114700

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls

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Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls

Infections, Papillomavirus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial