Last updated: 11/07/2018 01:59:15
Human papillomavirus (HPV) vaccine consistency and non-inferiority trial in young adult women
GSK study ID
107476 (M18)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Timeframe: At months 18*, 24, 36 and 48
Secondary outcomes:
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in cervical samples
Timeframe: At months 24, 36, and 48
Titers of Anti-HPV-16 and anti-HPV-18 Immunoglobulin G (IgG) Antibodies in blood samples
Timeframe: At Months 24, 36 and 48
Number of subjects reporting pregnancies, new onset chronic diseases (NOCDs) and other medically significant conditions (MSCs)
Timeframe: Throughout the study period (up to Month 48)
Number of subjects reporting SAEs
Timeframe: Throughout the study period (up to Month 48)
Interventions:
Biological/vaccine: Cervarix™
Enrollment:
770
Observational study model:
Not applicable
Primary completion date:
2006-30-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Papillomavirus type 16/18 infection, Cervical Intraepithelial Neoplasia
Product
SB580299
Collaborators
Not applicable
Study date(s)
June 2006 to June 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
10 - 25 years
Accepts healthy volunteers
Yes
- 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).
Inclusion and exclusion criteria
Inclusion 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.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-30-06
Actual study completion date
2006-30-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Primary Study
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