Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01277042
First received: January 13, 2011
Last updated: April 3, 2012
Last verified: March 2012
  Purpose

This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of subjects will receive the HPV vaccine and the other group will receive an active control (GSK Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be compared with those from the HPV group included in the NCT00779766 study (aged 18-25 years).


Condition Intervention Phase
Human Papillomavirus (HPV) Type 16/18 Infections
Cervical Neoplasia
Biological: GSK580299 (CervarixTM)
Biological: Engerix-BTM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK 580299) in Healthy Adult Chinese Female Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HPV-16 and anti-HPV-18 seroconversion rates assessed by ELISA in women aged 26-45 years and women aged 18-25 years (NCT00779766 study) [ Time Frame: One month after third vaccination (Month 7) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-HPV-16 and anti-HPV-18 seropositivity rates and antibody titres assessed by ELISA in all subjects [ Time Frame: Before vaccination (Month 0) and one month after third vaccination (Month 7) ] [ Designated as safety issue: No ]
  • Occurrence of each solicited symptom [ Time Frame: During the 7 days (Days 0 - 6) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 30 days (Days 0 - 29) after any vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (SAEs) [ Time Frame: Throughout the study (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]
  • Occurrence of medically significant conditions (including potential immunemediated diseases) [ Time Frame: Throughout the study (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]
  • Occurrence of pregnancies and pregnancy outcomes [ Time Frame: Throughout the study (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]

Enrollment: 1212
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Group receiving the HPV vaccine
Biological: GSK580299 (CervarixTM)
3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)
Active Comparator: Group B
Group receiving the hepatitis B vaccine
Biological: Engerix-BTM
3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)

Detailed Description:

This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to:

  • The removal of 3 outcome measures
  • The update of 1 outcome measure
  Eligibility

Ages Eligible for Study:   26 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent prior to study enrolment.
  • Healthy adult females from Chinese origin and residing in China between and including 26 and 45 years of age at the time of the first vaccination.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
  • Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test before each vaccination.

Subjects must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy, be one year post-menopausal, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and agree to continue such precautions during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines 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.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine.
  • 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 (pharmaceutical product or device).
  • A subject 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 subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
  • Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period.
  • Previous administration of 3-O-desacyl-4'-monophosphoryl lipid A or AS04 adjuvant.
  • Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period.
  • History of hepatitis B infection.
  • Known exposure to hepatitis B within the previous 6 weeks.
  • History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
  • History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine (e.g. aluminium).
  • Hypersensitivity to latex.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277042

Locations
China, Jiangsu
GSK Investigational Site
Jintan, Jiangsu, China, 213200
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01277042     History of Changes
Other Study ID Numbers: 114590
Study First Received: January 13, 2011
Last Updated: April 3, 2012
Health Authority: China: Jiangsu Center for Disease Control and Prevention

Keywords provided by GlaxoSmithKline:
Safety
HPV vaccine
Immune response
Human papillomavirus
China

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013