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