A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females

NCT00549900 | Completed Phase 1 Results

• 1 other identifier: 107336
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Papillomavirus

Keywords

HPV vaccine,; Cervical cancer; Human papillomavirus infection,

Outcome Measures

Primary Outcomes (6)

• Number of Subjects Reporting Serious Adverse Events

  Serious adverse events are defined as medical occurrences that result in death, are 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.

  Throughout the study period (up to Month 7)

• Number of Subjects Reporting Solicited Local Symptoms

  Solicited local symptoms assessed include pain, redness and swelling.

  During the 7-day (Day 0-6) period following each vaccination

• Number of Subjects Reporting Solicited General Symptoms

  Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.

  During the 7-day (Day 0-6) period following each vaccination

• Number of Subjects Reporting Unsolicited Adverse Events (AEs)

  An unsolicited adverse event is defined as 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.

  Within 30 days (Day 0-29) after any vaccination

• Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters

  Hematological and biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), basophils, creatinine, eosinophils, hematocrit, lymphocytes, monocytes, neutrophils, platelets, red blood cell, and white blood cells. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below".

  At Month 0 and Month 7

• Number of Subjects Reporting Medically Significant Adverse Events

  Medically significant AEs were defined as AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.

  Throughout the study period (up to Month7)

Study Arms (1)

Cervarix Group

EXPERIMENTAL

Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.

Biological: GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)

Interventions

GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine) BIOLOGICAL

Intramuscular injection, 3 doses

Also known as: GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine

Cervarix Group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Jintan, Jiangsu, China

Location

Related Publications (1)

• 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.

  PMID: 21801604 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Interventions

human papillomavirus vaccine, L1 type 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 26, 2007
• Study Start: December 2, 2007
• Primary Completion: July 12, 2008
• Study Completion: July 12, 2008
• Last Updated: July 20, 2018
• Results First Posted: December 17, 2009

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)