Healthy volunteers [For active immunisation of females from 9 years of age onwards for the prevention of persistent infection, premalignant genital (cervical, vulvar and vaginal) lesions and cervical, vulvar and vaginal cancers (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic Human Papillomaviruses (HPV)]. MedDRA version: 16.1 Level: LLT Classification code 10071147 Term: Human papilloma virus immunization System Organ Class: 100000004865 MedDRA version: 16.1 Level: LLT Classif
Conditions
Interventions
Trade Name: Cervarix
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Current Sponsor code: HPV-16 L1
Other descriptive name: Human Papillomavirus 1 type 16 L1 protein
Concentratio
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 207 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 |
|---|---|
| Main Objective: To assess the persistence of anti-HPV-16 and anti-HPV-18 antibodies [by Enzyme Linked Immunosorbent assay (ELISA)] in subjects, previously vaccinated with 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);Primary end point(s): Immune persistence 6.5 years after first vaccination with HPV-16/18 (20 µg of each antigen) administered in the study HPV-048 PRI (110659): - Anti-HPV-16/18 seroconversion rates and antibody titres (by ELISA).;Secondary Objective: - To assess the immune responses to HPV types 16 and 18 [as determined by Pseudovirion-based neutralization assay (PBNA)] for subjects having 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). - To evaluate the long-term safety of the HPV-16/18 vaccine up to approximately 6.5 years after administration of the first vaccine dose in the study HPV-048 PRI (110659). ;Timepoint(s) of evaluation of this end point: 6.5 years after first vaccination with HPV-16/18 administered in the study HPV-048 PRI (NCT00541970) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity after 6.5 years after first vaccination with HPV-16/18 (20 µg of each antigen) vaccine administered in the study HPV-048 PRI (110659): - Anti-HPV-16/18 seroconversion rates and antibody titres (by PBNA). Safety: - Occurrence of SAEs related to investigational product, after primary study completion up to end of the study.;Timepoint(s) of evaluation of this end point: - 6.5 years after first vaccination with HPV-16/18 (20 µg of each antigen) administered in the study HPV-048 PRI (NCT00541970) - After primary study completion (Month 60) up to end of the study (Visit 1 at Year 6.5) | — |
Countries
Canada, Germany
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed