Infections, Papillomavirus
Conditions
Keywords
Adolescents, Adults, Immunogenicity, 6.5 years, Safety, Antibody persistence, Human Papillomavirus (HPV) vaccine
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).
Interventions
PROCEDUREBlood sampling
Blood samples will be collected from all subjects at Year 6.5
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 32 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| Occurrence of SAEs | After primary study completion (Month 60) up to end of the study (Visit 1 at Year 6.5) |
Outcome results
None listed