Clinical trial NCT00549900: A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females
Official title: Safety and Immunogenicity Study of the HPV Vaccine (GSK-580299) in Healthy, Chinese, Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infections, Papillomavirus
Keywords: HPV vaccine,
Cervical cancer
Human papillomavirus infection,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A phase I, open label, single-centre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM), administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female subjects aged 15 - 45 years.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description: The rationale for the protocol posting amendment was to change the study population from 18-35 to 15-45 years and to allow subjects who were administered routine vaccines e.g. Hepatitis A\&B vaccines, meningococcal vaccines, Tetanus vaccine, Diphteria Tetanus Pertussis etc. up to 8 days before each HPV dose.

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 of Chinese origin, residing in China, aged between 15 - 45 years (inclusive) at the time of the first vaccination.
* Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the subject's parent or Legally Acceptable Representative (LAR), and written informed assent must be obtained from the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subjects must have a negative urine pregnancy test.
* Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent or must be using adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Pregnant or breastfeeding.
* Planning to become pregnant or likely to become pregnant
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days preceding and 30 days after the first dose of vaccine. Administration of some routine vaccines up to 8 days before the first dose of study vaccine is allowed.
* Previous administration of components of the investigational vaccine.
* Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
* Hypersensitivity to latex.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Known acute or chronic, clinically significant system conditions.
* Cancer or autoimmune disease under treatment.
* Acute disease at the time of enrolment.
* History of chronic alcohol consumption and/or drug abuse.

Primary outcomes:
measure: Number of Subjects Reporting Serious Adverse Events
timeFrame: Throughout the study period (up to Month 7)
measure: Number of Subjects Reporting Solicited Local Symptoms
timeFrame: During the 7-day (Day 0-6) period following each vaccination
measure: Number of Subjects Reporting Solicited General Symptoms
timeFrame: During the 7-day (Day 0-6) period following each vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: Within 30 days (Day 0-29) after any vaccination
measure: Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
timeFrame: At Month 0 and Month 7
measure: Number of Subjects Reporting Medically Significant Adverse Events
timeFrame: Throughout the study period (up to Month7)
Secondary outcomes:
Other outcomes:
Locations:
city: Jintan City
country: China
facility: GSK Investigational Site
state: Jiangsu
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Zhu FC, Li CG, Pan HX, Zhang YJ, Bi D, Tang HW, Datta S. Safety and immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine in healthy Chinese females aged 15 to 45 years: a phase I trial. Chin J Cancer. 2011 Aug;30(8):559-64. doi: 10.5732/cjc.010.10564.