Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women

NCT ID: NCT00337818

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 770 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-01-31

Brief Summary

The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.

Detailed Description

Approximately 750 study subjects received different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

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

Conditions

Papillomavirus Type 16/18 Infection; Cervical Intraepithelial Neoplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cervarix New Process

Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\]) produced with the new manufacturing process.

Group Type: EXPERIMENTAL

Cervarix™

Intervention Type: BIOLOGICAL

Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)

Cervarix Old Process Group

Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\]) produced with the old manufacturing process.

Group Type: EXPERIMENTAL

Cervarix™

Intervention Type: BIOLOGICAL

Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)

Cervarix Young/Lot 1 Group

Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\]) produced with the new manufacturing process (Lot 1).

Group Type: EXPERIMENTAL

Cervarix™

Intervention Type: BIOLOGICAL

Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)

Interventions

Cervarix™

Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• A female who enrolled in the HPV-012 (NCT00337818) study in Denmark, Estonia and Finland, received three doses of vaccine and completed Visit 4 (Month 7).
• Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative (LAR) and, in addition, the subject must sign and personally date a written informed assent).

Exclusion Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Tallinn, , Estonia

Countries

Estonia

Related Links

http://www.clinicaltrials.gov/ct/show/NCT00169494

Primary Study

Other Identifiers

107477

Identifier Type: OTHER

Identifier Source: secondary_id

107479

Identifier Type: OTHER

Identifier Source: secondary_id

107481

Identifier Type: OTHER

Identifier Source: secondary_id

107476 (M18)

Identifier Type: -

Identifier Source: org_study_id

NCT00337844

Identifier Type: -

Identifier Source: nct_alias

NCT00337857

Identifier Type: -

Identifier Source: nct_alias

NCT00338169

Identifier Type: -

Identifier Source: nct_alias