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

GlaxoSmithKline (GSK)

Status and phase: Withdrawn; Phase 3

Conditions: Infections, Papillomavirus

Treatments: Procedure: Blood sampling

Study type: Interventional

Funder types: Industry

Identifiers

NCT02100618

200255

2014-000060-17 (EudraCT Number)

Details and patient eligibility

About

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).

Sex: Female

Ages: 15 to 32 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

HPV Group 1

Experimental group

Description:

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).

Treatment:

Procedure: Blood sampling

HPV Group 2

Active Comparator group

Description:

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).

Treatment:

Procedure: Blood sampling