Clinical trial NCT00369824: Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Papillomavirus
Keywords: HPV
HPV, diptheria, pertussis, tetanus, meningitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 1330
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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
measure: 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
measure: 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:
measure: 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)
measure: 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
measure: Concentration of Anti-D and Anti-T Antibodies
timeFrame: Before and one month after vaccination with Boostrix
measure: Number of Subjects With Booster Response for Anti-D and Anti-T
timeFrame: One month after vaccination with Boostrix
measure: Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN
timeFrame: One month after vaccination with Boostrix
measure: Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response
timeFrame: One month after vaccination with Menactra
measure: Number of Subjects Reporting Solicited Local Symptoms
timeFrame: During the 7-day period following each vaccination
measure: Number of Subjects Reporting Solicited General Symptoms
timeFrame: During the 7-day period following each vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day period following each vaccination
measure: 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)
measure: 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)
measure: 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)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Madera
country: United States
facility: GSK Investigational Site
state: California
city: Rolling Hills Estates
country: United States
facility: GSK Investigational Site
state: California
city: Centennial
country: United States
facility: GSK Investigational Site
state: Colorado
city: Golden
country: United States
facility: GSK Investigational Site
state: Colorado
city: Thornton
country: United States
facility: GSK Investigational Site
state: Colorado
city: Cocoa Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Arkansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Bossier City
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Milford
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Niles
country: United States
facility: GSK Investigational Site
state: Michigan
city: Stevensville
country: United States
facility: GSK Investigational Site
state: Michigan
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Edison
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Whitehouse Station
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Cary
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Laurinburg
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Sylva
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Akron
country: United States
facility: GSK Investigational Site
state: Ohio
city: Boardman
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Gray
country: United States
facility: GSK Investigational Site
state: Tennessee
city: San Angelo
country: United States
facility: GSK Investigational Site
state: Texas
city: Burke
country: United States
facility: GSK Investigational Site
state: Virginia
city: Vienna
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Wheeler CM, Harvey BM, Pichichero ME, Simon MW, Combs SP, Blatter MM, Marshall GS, Catteau G, Dobbelaere K, Descamps D, Dubin G, Schuind A. 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. 2011 Dec;30(12):e225-34. doi: 10.1097/INF.0b013e31822d28df.