Brief Title
Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
Official Title
A Long-term, Open, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1/AS04 Vaccine in Healthy Female Subjects Vaccinated Either Pre- or Post-menarche in the Primary Study
Brief Summary
The study will be extended for subjects who received all three doses of vaccine in Finland,
Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18
vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin
and genitals in men and women. Several types of HPV infection are transmitted by sexual
activity and, in women, can infect the cervix (part of the uterus or womb). This infection
often goes away by itself, but if it does not go away (this is called persistent infection),
it can lead in women over a long period of time to cancer of the cervix. If a woman is not
infected by HPV, it is very unlikely that she will get cervical cancer. This study will
evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified
manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine
safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.
Detailed Description
Approximately 750 study subjects received different lots of the HPV vaccine administered
intramuscularly according to a 0-1-6 month schedule.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Secondary Outcome
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
Condition
Papillomavirus Type 16/18 Infection
Intervention
Cervarix™
Study Arms / Comparison Groups
Cervarix New Process
Description: Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the new manufacturing process.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
770
Start Date
June 2006
Completion Date
January 2009
Primary Completion Date
June 2006
Eligibility Criteria
Inclusion Criteria:
- A female who enrolled in the HPV-012 (NCT00337818) study in Denmark, Estonia and
Finland, received three doses of vaccine and completed Visit 4 (Month 7).
- Written informed consent obtained from the subject prior to enrolment (for subjects
below the legal age of consent, written informed consent must be obtained from a
parent or legally acceptable representative (LAR) and, in addition, the subject must
sign and personally date a written informed assent).
Exclusion criteria
- Use of any investigational or non-registered product (drug or vaccine) or planned use
during the study period.
- 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).
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring
less than three months prior to blood sampling.
- Administration of immunoglobulins and/or any blood products within the three months
preceding blood sampling.
Gender
Female
Ages
10 Years - 25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
GSK Clinical Trials, ,
Location Countries
Estonia
Location Countries
Estonia
Administrative Informations
NCT ID
NCT00337818
Organization ID
107476 (M18)
Secondary IDs
107477
Responsible Party
Sponsor
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, Study Director, GlaxoSmithKline
Verification Date
May 2017