Clinical trial NCT00359619: Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine
Official title: A Long-term, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Novel HPV Vaccine in Healthy Female Subjects Vaccinated in the Primary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Papillomavirus
Papillomavirus Vaccines
Keywords: HPV vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-02
Enrollment: 383
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go 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. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility criteria: Inclusion Criteria:

* A female who enrolled in the study 102115 and received three doses of vaccine.
* Written informed consent obtained from the subject prior to enrolment.

Exclusion Criteria:

* Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
* 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.
* Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.

Primary outcomes:
measure: Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.
timeFrame: At Months 18, 24, 36 and 48.
measure: Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.
timeFrame: At Months 18, 24, 36 and 48.
measure: Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies
timeFrame: At Months 18, 24, 36 and 48.
measure: Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.
timeFrame: At Months 18, 24, 36 and 48.
measure: Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.
timeFrame: At Months 18, 24, 36 and 48.
measure: Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
timeFrame: At Months 18, 24, 36 and 48.
Secondary outcomes:
measure: Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.
timeFrame: At Months 18, 24, 36 and 48.
measure: Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.
timeFrame: At Months 18, 24, 36 and 48.
measure: Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.
timeFrame: At Months 18, 24, 36 and 48.
measure: Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.
timeFrame: At Months 18, 24, 36 and 48.
measure: Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)
timeFrame: From Month 0 to Months 18, 24, 36 and 48
measure: Number of Subjects With at Least One Medically Significant Condition (MAEs).
timeFrame: From Month 0 to Months 18, 24, 36 and 48
measure: Number of Subjects With Any Serious Adverse Events (SAEs).
timeFrame: From Month 0 to Months 18, 24, 36 and 48
measure: Number of Subjects With Pregnancy Outcomes.
timeFrame: From Month 0 to Month 18
measure: Number of Subjects With Pregnancy Outcomes.
timeFrame: From Month 0 to Month 24
measure: Number of Subjects With Pregnancy Outcomes.
timeFrame: From Month 0 to Month 36
measure: Number of Subjects With Pregnancy Outcomes.
timeFrame: From Month 0 to Month 48
Other outcomes:
Locations:
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Golden
country: United States
facility: GSK Investigational Site
state: Colorado
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Tienen
country: Belgium
facility: GSK Investigational Site
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: