Know Cancer

or
forgot password

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females


Phase 3
9 Years
25 Years
Open (Enrolling)
Female
Cervical Cancer, HPV Type 16/18 Infections

Thank you

Trial Information

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females


Inclusion Criteria:



- Subjects who the investigator believes can and will comply with the requirements of
the protocol or/ and subjects who the investigator believes their parent(s)/Legally
Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of
the protocol

- A female between, and including, 9 and 25 years of age at the time of the first
vaccination

- Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the
subject prior to enrolment in the study. In addition, subjects below the legal age of
consent should sign and personally date a written informed assent form

- Healthy subjects

- Female subjects of non-childbearing potential may be enrolled in the study

- Female subjects of childbearing potential may be enrolled in the study, if the
subject:

- has practiced adequate contraception for 30 days prior to vaccination, and

- has a negative pregnancy test on the day of vaccination, and

- has agreed to continue adequate contraception during the entire vaccination
period and up to two months after the last study vaccine dose

Exclusion Criteria:

- Pregnant or breastfeeding

- A female planning to become pregnant, likely to become pregnant or planning to
discontinue contraceptive precautions during the entire vaccination period and up to
two months after the last study vaccine dose

- Previous vaccination against HPV or planned administration of another HPV vaccine
during the study

- Child in care. A child in care is a child who has been placed under the control or
protection of an agency, organisation, institution or entity by the courts, the
government or a government body, acting in accordance with powers conferred on them
by law or regulation. The definition of a child in care does not include a child who
is adopted or has an appointed legal guardian.

- 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

- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose. History of allergic disease, suspected
allergy or reactions likely to be exacerbated by any component of the study vaccines

- Cancer or autoimmune disease under treatment

- Planned administration/administration of a vaccine/product not foreseen by the study
protocol within 30 days before each dose of vaccine. Administration of routine
meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus
and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study
vaccine is allowed. Enrolment will be deferred until the subject is outside of
specified window

- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product

- Previous administration of MPL or AS04 adjuvant.

- 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

- Any confirmed or suspected immunosuppressive or immunodeficient condition

- Family history of congenital or hereditary immunodeficiency

- Major congenital defects or serious chronic illness

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests, which in the opinion of the investigator precludes administration of the study
vaccine

- Acute disease and/or fever at the time of enrolment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Anti-HPV-16/18 seroconversion rates in terms of number of seroconverted subjects in the group (0,6) and the group (0,1,6)

Outcome Time Frame:

1 month after the last dose of study vaccine (Month 7)

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Thailand: Institutional Review Board, Faculty of Medicine, Chulalongkorn University

Study ID:

114700

NCT ID:

NCT01381575

Start Date:

June 2011

Completion Date:

December 2014

Related Keywords:

  • Cervical Cancer
  • HPV Type 16/18 Infections
  • HPV infection
  • Human Papillomavirus
  • Cervical cancer
  • HPV-16
  • HPV-18
  • vaccine
  • Uterine Cervical Neoplasms

Name

Location