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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

Phase 3
11 Years
18 Years
Not Enrolling
Human Papillomavirus Type-16/-18 Infection, Papillomavirus Vaccines, Cervical Neoplasia

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Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome 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)

Outcome Description:

Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)

Outcome Time Frame:

Before and one month after vaccination with Boostrix

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

February 2008

Related Keywords:

  • Human Papillomavirus Type-16/-18 Infection
  • Papillomavirus Vaccines
  • Cervical Neoplasia
  • HPV
  • HPV, diptheria, pertussis, tetanus, meningitis
  • Neoplasms



GSK Investigational Site Phoenix, Arizona  85013 - 4496
GSK Investigational Site Little Rock, Arkansas  72205
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Lexington, Kentucky  40536-0098
GSK Investigational Site New Orleans, Louisiana  70112
GSK Investigational Site Springfield, Massachusetts  01107
GSK Investigational Site Albuquerque, New Mexico  87109
GSK Investigational Site Raleigh, North Carolina  27609
GSK Investigational Site Akron, Ohio  44304
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Savannah, Georgia  31405
GSK Investigational Site Royal Oak, Michigan  48073
GSK Investigational Site Pittsburgh, Pennsylvania  15213
GSK Investigational Site Columbia, South Carolina  29210
GSK Investigational Site Germantown, Tennessee  38138
GSK Investigational Site Salem, Virginia  24153
GSK Investigational Site New York, New York  10021
GSK Investigational Site Birmingham, Alabama  35209
GSK Investigational Site Aurora, Colorado  80012
GSK Investigational Site Kansas City, Kansas  66160
GSK Investigational Site Omaha, Nebraska  68131
GSK Investigational Site Edison, New Jersey  08837