Clinical trial NCT02100618: Antibody Persistence for GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) Administered in Healthy Adults and Adolescents, 6.5 Years After First Vaccination in the Primary Study
Official title: Evaluation of Antibody Persistence for GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) Administered in Healthy Adults and Adolescents, 6.5 Years After First Vaccination in the Primary Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Infections, Papillomavirus
Keywords: Adolescents
Adults
Immunogenicity
6.5 years
Safety
Antibody persistence
Human Papillomavirus (HPV) vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 32
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to establish the long-term persistence of the immune response and safety of the HPV vaccine in healthy females who were aged 9 to 25 years in the primary study (NCT00541970).


Eligibility criteria: Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
* Subjects who completed their primary vaccination and received either two or three doses of GSK Biologicals' HPV-16/18 vaccine according to a 0,6-months schedule or a 0,1,6-months schedule in the study HPV-048 PRI (110659) (NCT00541970).
* A female between, and including, 9 and 14 years of age or 15 and 25 years of age, at the time of first vaccination, depending on which group they belonged to in the study HPV-048 PRI (110659) (NCT00541970), i.e., 9-14 year old subjects should have received two doses of GSK Biologicals' HPV-16/18 vaccine according to a 0,6-months schedule and 15-25 year old subjects should have received three doses of GSK Biologicals' HPV-16/18 vaccine according to a 0,1,6-months schedule.
* Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product (drug or vaccine) other than the HPV-16/18 study vaccine administered in the study HPV-048 PRI (110659) (NCT00541970) from the last visit of the primary study up to the current study visit or planned use during the study period.
* Administration of any HPV vaccine from the last visit of the primary study up to the current study visit or planned use during the study period.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within three months prior to blood sampling. Inhaled and topical steroids are allowed.
* Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before study entry, with the exception of routine meningococcal, inactivated influenza, hepatitis B, diphtheria/tetanus and/or diphtheria/tetanus-containing, poliomyelitis and/or pertussis vaccines up to 8 days before study entry. Enrolment will be deferred until the subject is outside of specified window.
* 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 vaccine/product.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Cancer or autoimmune disease under treatment.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the blood sampling.

Primary outcomes:
measure: Evaluation of immune persistence in terms of antibody titres
timeFrame: 6.5 years after first vaccination with HPV-16/18 administered in the study HPV-048 PRI (NCT00541970)
Secondary outcomes:
measure: Evaluation of immunogenicity in terms of seroconversion rates (SCRs) and antibody titres
timeFrame: 6.5 years after first vaccination with HPV-16/18 (20 µg of each antigen) administered in the study HPV-048 PRI (NCT00541970)
measure: Occurrence of SAEs
timeFrame: After primary study completion (Month 60) up to end of the study (Visit 1 at Year 6.5)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: