Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Cervical Intraepithelial Neoplasia; Papillomavirus Infection

Treatments: Biological: GSK Biologicals' HPV-16/18 Vaccine (Cervarix™); Biological: Havrix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00316706

104902 (Other Identifier)

104918 (Other Identifier)

104896 (month 18 FU)

104904 (Other Identifier)

Details and patient eligibility

About

This protocol posting deals with objectives & outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA). The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924).

The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924). During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the primary study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Enrollment: 1,245 patients

Sex: Female

Ages: 10 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A female who enrolled in the immunological subset of the 580299-013 study, received the three doses of vaccine/control according to the treatment allocation and completed the 580299-013 study.
• Written informed assent obtained from the subject and written informed consent obtained from a parent or legally acceptable representative of the subject.

Exclusion criteria

• 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 product (pharmaceutical product or device).
• Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than 3 months prior to blood sampling.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding blood sampling.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,245 participants in 2 patient groups

Cervarix Group

Experimental group

Description:

Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.

Treatment:

Biological: GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)

Havrix Group

Active Comparator group

Description:

Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.

Treatment:

Biological: Havrix™