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
Phase 3
Withdrawn
- Conditions
- Infections, Papillomavirus
- Interventions
- Procedure: Blood sampling
- Registration Number
- NCT02100618
- Lead Sponsor
- GlaxoSmithKline
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HPV Group 1 Blood sampling Subjects who were aged 9-14 years at study entry and received two doses of the HPV-16/18 vaccine according to a 0,6-months schedule in the study HPV-048 PRI (NCT00541970). HPV Group 2 Blood sampling Subjects who were aged 15-25 years at study entry and received three doses of the HPV 16/18 vaccine according to a 0,1,6-months schedule in the study HPV-048 PRI (NCT00541970).
- Primary Outcome Measures
Name Time Method Evaluation of immune persistence in terms of antibody titres 6.5 years after first vaccination with HPV-16/18 administered in the study HPV-048 PRI (NCT00541970)
- Secondary Outcome Measures
Name Time Method Occurrence of SAEs After primary study completion (Month 60) up to end of the study (Visit 1 at Year 6.5) Evaluation of immunogenicity in terms of seroconversion rates (SCRs) and antibody titres 6.5 years after first vaccination with HPV-16/18 (20 µg of each antigen) administered in the study HPV-048 PRI (NCT00541970)