Last updated: 11/07/2018 00:59:41
Human Papilloma virus (HPV) vaccine trial in young adolescent women with GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
GSK study ID
104896 (month 18 FU)
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 GSK Biologicals’ HPV vaccine (580299) in healthy female subjects vaccinated in study HPV-013
Trial description: This protocol posting deals with objectives & outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA). The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924). During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the primary study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit.The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-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 18, 24, 36 and 48 months
Secondary outcomes:
Titers of anti-3-O-desacyl-4'-monophosphoryl lipid A (anti-MPL) antibodies during the initial 2 years follow-up
Timeframe: At Months 18 and 24
Titers of anti-3-O-desacyl 4'-monophosphoryl lipid A (anti-MPL) antibodies during the last 2 years follow-up
Timeframe: At Month 36 and 48
Number of subjects reporting pregnancies, serious adverse events (SAEs), new onset chronic diseases (NOCDs), and conditions prompting emergency room (ER) visits or physician visits that are not related to common diseases during the first 2 years follow-up
Timeframe: From Month 18 to Month 24
Number of subjects reporting pregnancies, serious adverse events (SAEs), new onset chronic diseases (NOCDs), and conditions prompting emergency room during the last 2 years follow-up
Timeframe: From Month 24 to Month 48
Interventions:
Biological/vaccine: GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)
Biological/vaccine: Havrix™
Enrollment:
1245
Observational study model:
Not applicable
Primary completion date:
2007-31-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cervical Intraepithelial Neoplasia, Papillomavirus Infection
Product
SB580299
Collaborators
Not applicable
Study date(s)
October 2005 to May 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
10 - 14 years
Accepts healthy volunteers
Yes
- A female who enrolled in the immunological subset of the 580299-013 study, received the three doses of vaccine/control according to the treatment allocation and completed the 580299-013 study.
- Written informed assent obtained from the subject and written informed consent obtained from a parent or legally acceptable representative of the subject.
- 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).
- Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- A female who enrolled in the immunological subset of the 580299-013 study, received the three doses of vaccine/control according to the treatment allocation and completed the 580299-013 study.
- Written informed assent obtained from the subject and written informed consent obtained from a parent or legally acceptable representative of the subject.
Exclusion criteria:
- 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).
- Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than 3 months prior to blood sampling.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding blood sampling.
Trial location(s)
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44866
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18109
Status
Study Complete
Location
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
Status
Study Complete
Location
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Niebuell, Schleswig-Holstein, Germany, 25899
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
Status
Study Complete
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
Status
Study Complete
Location
GSK Investigational Site
Brunsbuettel, Schleswig-Holstein, Germany, 25541
Status
Study Complete
Location
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Location
GSK Investigational Site
Buetzow, Mecklenburg-Vorpommern, Germany, 18246
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Harrislee, Schleswig-Holstein, Germany, 24955
Status
Study Complete
Location
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-31-05
Actual study completion date
2007-31-05
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
Additional information
Not applicable
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