Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Papillomavirus

Treatments: Biological: Menactra TM; Biological: Boostrix TM; Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00369824

107682

Details and patient eligibility

About

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.

Enrollment: 1,330 patients

Sex: Female

Ages: 11 to 18 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,330 participants in 6 patient groups

Cervarix + Boostrix/Menactra Group

Experimental group

Description:

Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.

Treatment:

Biological: Boostrix TM

Biological: Menactra TM

Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)

Cervarix + Menactra/Boostrix Group

Experimental group

Description:

Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.

Treatment:

Biological: Boostrix TM

Biological: Menactra TM

Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)

Cervarix + Boostrix + Menactra Group

Experimental group

Description:

Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.

Treatment:

Biological: Boostrix TM

Biological: Menactra TM

Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)

Boostrix/Cervarix Group

Experimental group

Description:

Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.

Treatment:

Biological: Boostrix TM

Biological: Menactra TM

Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)

Menactra/Cervarix Group

Experimental group

Description:

Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.

Treatment:

Biological: Menactra TM

Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)

Cervarix Group

Experimental group

Description:

Subjects received Cervarix at Months 0, 1 and 6.

Treatment:

Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)