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.

• Conditions: 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: 16.1Level: LLTClassification code 10071147Term: Human papilloma virus immunizationSystem Organ Class: 100000004865; MedDRA version: 16.1Level: LLTClassification code 10058580Term: Human papilloma virus serology testSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-000060-17-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-19
• Last Update Posted: 11 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 222

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

- 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 clinical trial of medicinal product
• Study Design: Not specified