Last updated: 11/03/2018 09:45:23
Evaluation of safety and immunogenicity of co-administering HPV vaccine with other vaccines in healthy female subjects
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomized, open study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV vaccine Co-administered intramuscularly with Boostrix® and/or Menactra™ in healthy female subjects aged 11–18 years
Trial description: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase 3b study is designed to evaluate the safety and immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals’ HPV vaccine (580299) as compared to the administration of any of the vaccines alone.The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of subjects with anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibody concentrations above 1.0 international unit per milliliter (IU/mL)
Timeframe: Before and one month after vaccination with Boostrix
Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous hemagglutinin (Anti-FHA) Antibodies
Timeframe: Before and one month after vaccination with Boostrix
Titer of meningococcal serogroup A (Anti-A), meningococcal serogroup C (Anti-C), meningococcal serogroup Y (Anti-Y) and meningococcal serogroup W-135 (Anti-W135) Antibodies
Timeframe: Before and one month after vaccination with Menactra
Secondary outcomes:
Number of subjects with anti-human papilloma virus 16 (anti-HPV16) and anti-human papilloma virus 18 (anti-HPV18) antibody concentrations above pre-defined cut-off values
Timeframe: Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)
Number of subjects with anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibody concentrations above 0.1 international unit per milliliter (IU/mL)
Timeframe: Before and one month after vaccination with Boostrix
Concentration of Anti-D and anti-T antibodies
Timeframe: Before and one month after vaccination with Boostrix
Number of subjects with booster response for anti-D and anti-T
Timeframe: One month after vaccination with Boostrix
Number of subjects with Booster response for anti-PT, anti-FHA and anti-PRN
Timeframe: One month after vaccination with Boostrix
Number of subjects with anti-A, anti-C, anti-Y and anti-W135 vaccine response
Timeframe: One month after vaccination with Menactra
Number of subjects reporting solicited local symptoms
Timeframe: During the 7-day period following each vaccination
Number of subjects reporting solicited general symptoms
Timeframe: During the 7-day period following each vaccination
Number of subjects reporting unsolicited adverse events (AEs)
Timeframe: During the 30-day period following each vaccination
Number of subjects reporting serious adverse events
Timeframe: During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
Number of subjects reporting unsolicited adverse events as new onset chronic diseases (NOCDs)
Timeframe: During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)
Number of subjects reporting medically significant adverse events (AEs)
Timeframe: During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
Interventions:
Enrollment:
1330
Primary completion date:
2007-22-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Wheeler C et al. (2011) Immunogenicity and Safety of Human Papillomavirus-16/18 AS04-adjuvanted Vaccine Coadministered With Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine and/or Meningococcal Conjugate Vaccine to Healthy Girls 11 to 18 Years of Age: Results From a Randomized Open Trial. Pediatr Infect Dis J. 30(12):p e225–e234.
Medical condition
Infections, Papillomavirus
Product
SB580299, SB776423
Collaborators
Not applicable
Study date(s)
September 2006 to February 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
11 - 18 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that they can, and will, comply with the requirements of the protocol should be enrolled in the study.
- A female between, and including, 11 and 18 years of age at the time of the first vaccination.
- 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.
- Concurrently participating in another clinical study, at any time during the study period (up to the Month 12/13 visit), in which the subject has been or will be exposed to an investigational or a non-investigational product.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that they can, and will, comply with the requirements of the protocol should be enrolled in the study.
- A female between, and including, 11 and 18 years of age at the time of the first vaccination.
- Written informed consent obtained from parents/legally acceptable representative of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject is 18 years of age.
- Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study.
- Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases, according to the recommended vaccination schedule at the time.
- Subjects must have a negative urine pregnancy test.
- Subjects of childbearing potential at the time of study entry are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects also are required to agree to continue such precautions for two months after completion of the vaccination series. Female subjects who reach menarche (began menstruating) during the study and therefore become of child-bearing potential are required to agree to follow the same precautions.
Exclusion criteria:
- 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.
- Concurrently participating in another clinical study, at any time during the study period (up to the Month 12/13 visit), in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine. 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.
- A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
- Pregnant or breastfeeding women.
- Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- previous administration of components of the investigational vaccine
- Administration of a pre-school booster of diphtheria, tetanus, pertussis vaccine within the previous five years.
- Administration of a diphtheria-tetanus booster or tetanus-diphteria-acellular pertussis (Tdap) vaccine within the previous five years.
- Previous vaccination against Neisseria meningitidis.
- Hypersensitivity to latex.
- Cancer or autoimmune disease under treatment.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine.
- History of encephalopathy within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
- Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy.
- Temperature of >= 105°F within 48 hours of receipt of a prior dose of diphteria- tetanu-pertussis (DTP) vaccine, not due to another identifiable cause.
- Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP vaccine.
- Seizures with or without fever within three days of a prior dose of DTP vaccine.
- Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid within the previous 10 years.
- Previous history of Guillain-Barré syndrome.
- Any confirmed or suspected immunosuppressive or immunodeficient condition
- Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness
- 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.
Trial location(s)
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
San Angelo, Texas, United States, 76904
Status
Study Complete
Location
GSK Investigational Site
Thornton, Colorado, United States, 80233
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16501
Status
Study Complete
Location
GSK Investigational Site
Whitehouse Station, New Jersey, United States, 08889
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30062
Status
Study Complete
Location
GSK Investigational Site
Edison, New Jersey, United States, 08817
Status
Study Complete
Location
GSK Investigational Site
Sylva, North Carolina, United States, 28779
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Greenville, Pennsylvania, United States, 16125
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14620
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Stevensville, Michigan, United States, 49127
Status
Study Complete
Location
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
Status
Study Complete
Location
GSK Investigational Site
Laurinburg, North Carolina, United States, 28352
Status
Study Complete
Location
GSK Investigational Site
Cary, North Carolina, United States, 27518
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Milford, Massachusetts, United States, 01757
Status
Study Complete
Location
GSK Investigational Site
Arkansas City, Kansas, United States, 67005
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40503
Status
Study Complete
Location
GSK Investigational Site
Madera, California, United States, 93637
Status
Study Complete
Location
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15220
Status
Study Complete
Location
GSK Investigational Site
Centennial, Colorado, United States, 80112
Status
Study Complete
Location
GSK Investigational Site
Cocoa Beach, Florida, United States, 32931
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bossier City, Louisiana, United States, 71111
Status
Study Complete
Location
GSK Investigational Site
Vienna, Virginia, United States, 22180
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97216
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Golden, Colorado, United States, 80401
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29401
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2007-22-11
Actual study completion date
2008-13-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website