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

NCT00337818 | Completed Phase 3 Results

• 4 other identifiers: 107476 (M18)107477107479107481
• Study Type: interventional
• Target: 770
• Locations: 1 country
• Sites: 1

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.

Conditions

Papillomavirus Type 16/18 Infection; Cervical Intraepithelial Neoplasia

Keywords

Non-inferiority; Immunogenicity; HPV Vaccine Consistency

Outcome Measures

Primary Outcomes (1)

• Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies

  Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). \*Data for Month 18 outcome variables were incorporated into the Month 24 analyses.

  At months 18*, 24, 36 and 48

Secondary Outcomes (4)

• Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples

  At months 24, 36, and 48

• Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples

  At Months 24, 36 and 48

• Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)

  Throughout the study period (up to Month 48)

• Number of Subjects Reporting SAEs

  Throughout the study period (up to Month 48)

Study Arms (3)

Cervarix New Process

EXPERIMENTAL

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.

Biological: Cervarix™

Cervarix Old Process Group

EXPERIMENTAL

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.

Biological: Cervarix™

Cervarix Young/Lot 1 Group

EXPERIMENTAL

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).

Biological: Cervarix™

Interventions

Cervarix™ BIOLOGICAL

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

Cervarix New Process; Cervarix Old Process Group; Cervarix Young/Lot 1 Group

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tallinn, 1162, Estonia

Location

Related Links

• Primary Study

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

human papillomavirus vaccine, L1 type 16, 18

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2006
• First Posted: June 16, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2006
• Study Completion: January 1, 2009
• Last Updated: May 30, 2017
• Results First Posted: March 2, 2010

Record last verified: 2017-05

Locations

ES (1)