Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus Vaccine (Cervarix™) When Co-administered With GSK Biologicals' Hepatitis A Vaccine (Havrix®) in Healthy Female Adolescents Aged 9-14 Years
Primary Purpose
Infections, Papillomavirus
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cervarix™
Havrix
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Papillomavirus focused on measuring Adolescents, Havrix, Immunogenicity, Cervarix, Safety
Eligibility Criteria
Inclusion Criteria:
- A female between, and including, 9 and 14 years of age at the time of the first vaccination.
- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrollment.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- 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 treatment period and for two months after completion of the vaccination series.
Exclusion Criteria:
- Child in care.
- 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 (up to Month 12).
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and 30 days after the first dose of vaccine with the exception of routine vaccines such as meningococcal, pertussis, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine.
- Concurrently participating in another clinical study, at any time during the study period (up to Month 12), in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
- 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 12).
- Previous administration of MPL or AS04 adjuvant.
- Previous vaccination against hepatitis A or planned administration of any hepatitis A vaccine other than that foreseen by the study protocol during the study period (up to Month 12).
- Cancer or autoimmune disease under treatment.
- History of hepatitis A infection.
- Known exposure to hepatitis A within the previous 6 weeks.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Hypersensitivity to latex.
- 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 preclude administration of the study vaccine.
- 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 (up to Month 12).
Acute disease and/or fever at the time of enrollment.
- Fever is defined as temperature ≥ 37.0°C for oral, axillary or tympanic route. The preferred route for recording temperature in this study will be oral or axillary.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
HPV Group
HAV Group
HPV+HAV Group
Arm Description
Subjects will receive two doses of HPV vaccine intramuscularly
Subjects will receive two doses of HAV vaccine intramuscularly
Subjects will receive two doses of both HPV and HAV vaccines intramuscularly
Outcomes
Primary Outcome Measures
Anti-HPV-16/18 seroconversion status in the HPV group and the HPV+HAV group
Anti-HPV-16/18 antibody titres in the HPV group and the HPV+HAV group
Anti-HAV seroconversion status in the HPV+HAV group and the HAV group
Anti-HAV antibody titres in the HPV+HAV group and the HAV group
Secondary Outcome Measures
Anti-HPV-16/18 seroconversion status in the HPV group and the HPV+HAV group
Anti-HPV-16/18 antibody titres in the HPV group and the HPV+HAV group
Anti-HAV seroconversion status in the HPV+HAV group and the HAV group
Anti-HAV antibody titres in the HPV+HAV group and the HAV group
Occurrence of any and Grade 3 solicited local symptoms (injection site pain, redness and swelling) in all study groups
Occurrence of any, Grade 3 and causally related to vaccination solicited general symptoms in all study groups
Occurrence of any, Grade 3 and causally related to vaccination unsolicited AEs in all study groups
Occurrence of any and causally related to vaccination serious adverse events (SAEs) in all groups
Occurrence of medically significant conditions (MSCs) in all groups
Occurrence of potential immune-mediated diseases (pIMDs) in all groups
Occurrence of pregnancies and pregnancy outcomes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02082639
Brief Title
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus Vaccine (Cervarix™) When Co-administered With GSK Biologicals' Hepatitis A Vaccine (Havrix®) in Healthy Female Adolescents Aged 9-14 Years
Official Title
Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix™) (GSK-580299) When Co-administered With GSK Biologicals' Hepatitis A Vaccine (Havrix®) (GSK-208109) in Healthy Female Adolescents Aged 9-14 Years
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Because the Russian Authorities already approved the 2-dose Cervarix™ schedule, the study was no longer needed for registration and hence it was cancelled.
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety of two doses of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine when co-administered with GSK Biologicals' HAV vaccine according to 0, 6 month schedule, compared to the administration of either of these vaccines alone. The study will ascertain that the immune responses elicited to the two vaccines are not adversely impacted compared to when HPV-16/18 L1 VLP AS04 vaccine and HAV vaccine are administered alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Papillomavirus
Keywords
Adolescents, Havrix, Immunogenicity, Cervarix, Safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPV Group
Arm Type
Experimental
Arm Description
Subjects will receive two doses of HPV vaccine intramuscularly
Arm Title
HAV Group
Arm Type
Experimental
Arm Description
Subjects will receive two doses of HAV vaccine intramuscularly
Arm Title
HPV+HAV Group
Arm Type
Experimental
Arm Description
Subjects will receive two doses of both HPV and HAV vaccines intramuscularly
Intervention Type
Biological
Intervention Name(s)
Cervarix™
Intervention Description
2 doses intramuscularly in the deltoid muscle of the non-dominant arm
Intervention Type
Biological
Intervention Name(s)
Havrix
Intervention Description
2 doses intramuscularly in the deltoid muscle of the dominant arm
Primary Outcome Measure Information:
Title
Anti-HPV-16/18 seroconversion status in the HPV group and the HPV+HAV group
Time Frame
One month after the second dose (Month 7)
Title
Anti-HPV-16/18 antibody titres in the HPV group and the HPV+HAV group
Time Frame
One month after the second dose (Month 7)
Title
Anti-HAV seroconversion status in the HPV+HAV group and the HAV group
Time Frame
One month after the second dose (Month 7)
Title
Anti-HAV antibody titres in the HPV+HAV group and the HAV group
Time Frame
One month after the second dose (Month 7)
Secondary Outcome Measure Information:
Title
Anti-HPV-16/18 seroconversion status in the HPV group and the HPV+HAV group
Time Frame
One month after the second dose (Month 7)
Title
Anti-HPV-16/18 antibody titres in the HPV group and the HPV+HAV group
Time Frame
One month after the second dose (Month 7)
Title
Anti-HAV seroconversion status in the HPV+HAV group and the HAV group
Time Frame
One month after the second dose (Month 7)
Title
Anti-HAV antibody titres in the HPV+HAV group and the HAV group
Time Frame
One month after the second dose (Month 7)
Title
Occurrence of any and Grade 3 solicited local symptoms (injection site pain, redness and swelling) in all study groups
Time Frame
During the 7-day period (Day 0-6) following each vaccination
Title
Occurrence of any, Grade 3 and causally related to vaccination solicited general symptoms in all study groups
Time Frame
During the 7-day period (Day 0-6) following each vaccination
Title
Occurrence of any, Grade 3 and causally related to vaccination unsolicited AEs in all study groups
Time Frame
During the 30-day period (Day 0-29) following any vaccination
Title
Occurrence of any and causally related to vaccination serious adverse events (SAEs) in all groups
Time Frame
Throughout the active phase of the study (up to Month 7) and during the extended safety follow-up period (up to Month 12)
Title
Occurrence of medically significant conditions (MSCs) in all groups
Time Frame
Throughout the active phase (up to Month 7) and during the extended safety follow-up period (up to Month 12)
Title
Occurrence of potential immune-mediated diseases (pIMDs) in all groups
Time Frame
Throughout the active phase (up to Month 7) and during the extended safety follow-up period (up to Month 12)
Title
Occurrence of pregnancies and pregnancy outcomes
Time Frame
During the entire study period (Month 0 - Month 12)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A female between, and including, 9 and 14 years of age at the time of the first vaccination.
Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrollment.
Healthy subjects as established by medical history and clinical examination before entering into the study.
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 treatment period and for two months after completion of the vaccination series.
Exclusion Criteria:
Child in care.
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 (up to Month 12).
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and 30 days after the first dose of vaccine with the exception of routine vaccines such as meningococcal, pertussis, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine.
Concurrently participating in another clinical study, at any time during the study period (up to Month 12), in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
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 12).
Previous administration of MPL or AS04 adjuvant.
Previous vaccination against hepatitis A or planned administration of any hepatitis A vaccine other than that foreseen by the study protocol during the study period (up to Month 12).
Cancer or autoimmune disease under treatment.
History of hepatitis A infection.
Known exposure to hepatitis A within the previous 6 weeks.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Hypersensitivity to latex.
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 preclude administration of the study vaccine.
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 (up to Month 12).
Acute disease and/or fever at the time of enrollment.
Fever is defined as temperature ≥ 37.0°C for oral, axillary or tympanic route. The preferred route for recording temperature in this study will be oral or axillary.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus Vaccine (Cervarix™) When Co-administered With GSK Biologicals' Hepatitis A Vaccine (Havrix®) in Healthy Female Adolescents Aged 9-14 Years
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