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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00369824
Other study ID # 107682
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 26, 2006
Est. completion date February 13, 2008

Study information

Verified date November 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1330
Est. completion date February 13, 2008
Est. primary completion date November 22, 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 11 Years to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Different formulations of GSK Biologicals' HPV vaccine (580299)
Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
Menactra TM
One dose of vaccine administered intramuscularly
Boostrix TM
One dose of vaccine administered intramuscularly

Locations

Country Name City State
United States GSK Investigational Site Akron Ohio
United States GSK Investigational Site Albuquerque New Mexico
United States GSK Investigational Site Arkansas City Kansas
United States GSK Investigational Site Bardstown Kentucky
United States GSK Investigational Site Boardman Ohio
United States GSK Investigational Site Bossier City Louisiana
United States GSK Investigational Site Burke Virginia
United States GSK Investigational Site Cary North Carolina
United States GSK Investigational Site Centennial Colorado
United States GSK Investigational Site Chandler Arizona
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Cocoa Beach Florida
United States GSK Investigational Site Edison New Jersey
United States GSK Investigational Site Erie Pennsylvania
United States GSK Investigational Site Fountain Valley California
United States GSK Investigational Site Fresno California
United States GSK Investigational Site Golden Colorado
United States GSK Investigational Site Gray Tennessee
United States GSK Investigational Site Greenville Pennsylvania
United States GSK Investigational Site Jonesboro Arkansas
United States GSK Investigational Site Laurinburg North Carolina
United States GSK Investigational Site Lenexa Kansas
United States GSK Investigational Site Lexington Kentucky
United States GSK Investigational Site Little Rock Arkansas
United States GSK Investigational Site Long Beach California
United States GSK Investigational Site Louisville Kentucky
United States GSK Investigational Site Madera California
United States GSK Investigational Site Marietta Georgia
United States GSK Investigational Site Mesa Arizona
United States GSK Investigational Site Milford Massachusetts
United States GSK Investigational Site Mobile Alabama
United States GSK Investigational Site Niles Michigan
United States GSK Investigational Site Omaha Nebraska
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Portland Oregon
United States GSK Investigational Site Raleigh North Carolina
United States GSK Investigational Site Rochester New York
United States GSK Investigational Site Rolling Hills Estates California
United States GSK Investigational Site San Angelo Texas
United States GSK Investigational Site Stevensville Michigan
United States GSK Investigational Site Sylva North Carolina
United States GSK Investigational Site Thornton Colorado
United States GSK Investigational Site Uniontown Pennsylvania
United States GSK Investigational Site Vienna Virginia
United States GSK Investigational Site West Palm Beach Florida
United States GSK Investigational Site Whitehouse Station New Jersey
United States GSK Investigational Site Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL) Before and one month after vaccination with Boostrix
Primary Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies Concentrations given as Geometric Means Concentrations (GMCs) Before and one month after vaccination with Boostrix
Primary 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 Titers given as Geometric Mean Titers (GMTs) Before and one month after vaccination with Menactra
Secondary 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 Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies. Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)
Secondary 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) Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL) Before and one month after vaccination with Boostrix
Secondary Concentration of Anti-D and Anti-T Antibodies Concentrations given as Geometric Mean Concentrations (GMCs) Before and one month after vaccination with Boostrix
Secondary Number of Subjects With Booster Response for Anti-D and Anti-T Booster responses for anti-D and anti-T defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off: < 0.1 IU/mL): antibody titer at least 4 times the cut-off (post-vaccination titer = 0.4 IU/mL)
For initially seropositive subjects (pre-vaccination titer above 0.1 IU/mL): an increase in antibody titer of at least 4 times the pre-vaccination titer
One month after vaccination with Boostrix
Secondary Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN Booster responses defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off: < 5 EL.U/mL): antibody titers at least 4 times the cut-off,
For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,
For initially seropositive subjects with pre-vaccination titer = 20 EL.U/mL: an increase in antibody titers of at least two times the pre-vaccination titer
One month after vaccination with Boostrix
Secondary Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response Vaccine responses for anti-A, C, Y and W-135 defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off of 8): antibody titers at least 4 times the cut-off (post vaccination titer = 32)
For initially seropositive subjects (pre-vaccination titer above 8): antibody titers at least 4 times the pre-vaccination antibody titer
One month after vaccination with Menactra
Secondary Number of Subjects Reporting Solicited Local Symptoms Solicited local symptoms assessed include pain, redness and swelling. During the 7-day period following each vaccination
Secondary Number of Subjects Reporting Solicited General Symptoms Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria During the 7-day period following each vaccination
Secondary Number of Subjects Reporting Unsolicited Adverse Events (AEs) Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. During the 30-day period following each vaccination
Secondary Number of Subjects Reporting Serious Adverse Events Serious adverse events assessed include medical occurrences that results in death, is 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. 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)
Secondary Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes 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)
Secondary Number of Subjects Reporting Medically Significant Adverse Events (AEs) Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases. During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
See also
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Completed NCT00359619 - Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine Phase 2
Completed NCT00196937 - Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18 Phase 3
Completed NCT00534638 - Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents Phase 4
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Completed NCT00996125 - Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects Phase 3
Completed NCT00779766 - Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects Phase 3
Completed NCT01953822 - Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom N/A
Completed NCT01153906 - Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination N/A
Completed NCT01207999 - Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer N/A
Completed NCT00693615 - Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females Phase 2
Completed NCT00693966 - Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females Phase 2
Completed NCT00541970 - Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs Phase 1
Completed NCT01627561 - Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old Phase 3