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

NCT00316706 | Completed Phase 3 Results

• 4 other identifiers: 104896 (month 18 FU)104902104904104918
• Study Type: interventional
• Target: 1,245
• Locations: 5 countries
• Sites: 28

Brief Summary

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.

Conditions

Cervical Intraepithelial Neoplasia; Papillomavirus Infection

Keywords

Prophylaxis HPV-16/18 infections and cervical neoplasia

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).

  At 18, 24, 36 and 48 months

Secondary Outcomes (4)

• Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up

  At Months 18 and 24

• Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up

  At Month 36 and 48

• Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up

  From Month 18 to Month 24

• Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up

  From Month 24 to Month 48

Study Arms (2)

Cervarix Group

EXPERIMENTAL

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.

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

Havrix Group

ACTIVE COMPARATOR

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.

Biological: Havrix™

Interventions

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

Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule

Cervarix Group

Havrix™ BIOLOGICAL

Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.

Havrix Group

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (28)

GSK Investigational Site

Bogotá, 805, Colombia

Location

GSK Investigational Site

Bogotá, Colombia

Location

GSK Investigational Site

Deggingen, Baden-Wurttemberg, 73326, Germany

Location

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, 77955, Germany

Location

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

GSK Investigational Site

Tauberbischofsheim, Baden-Wurttemberg, 97941, Germany

Location

GSK Investigational Site

Weilheim, Bavaria, 82362, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Hamburg, Hamburg, 22307, Germany

Location

GSK Investigational Site

Wolfenbüttel, Lower Saxony, 38302, Germany

Location

GSK Investigational Site

Bützow, Mecklenburg-Vorpommern, 18246, Germany

Location

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, 18109, Germany

Location

GSK Investigational Site

Bochum, North Rhine-Westphalia, 44866, Germany

Location

GSK Investigational Site

Willich, North Rhine-Westphalia, 47877, Germany

Location

GSK Investigational Site

Trier, Rhineland-Palatinate, 54290, Germany

Location

GSK Investigational Site

Brunsbüttel, Schleswig-Holstein, 25541, Germany

Location

GSK Investigational Site

Flensburg, Schleswig-Holstein, 24937, Germany

Location

GSK Investigational Site

Harrislee, Schleswig-Holstein, 24955, Germany

Location

GSK Investigational Site

Husum, Schleswig-Holstein, 25813, Germany

Location

GSK Investigational Site

Niebüll, Schleswig-Holstein, 25899, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10315, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10967, Germany

Location

GSK Investigational Site

Weimar, Thuringia, 99425, Germany

Location

GSK Investigational Site

Comayagüela, Honduras

Location

GSK Investigational Site

La Chorrera, Provincia de Panamá, Panama

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

GSK Investigational Site

Tao Yuan County, 333, Taiwan

Location

Related Publications (1)

• Schwarz TF, Huang LM, Medina DM, Valencia A, Lin TY, Behre U, Catteau G, Thomas F, Descamps D. Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10-14 years. J Adolesc Health. 2012 Feb;50(2):187-94. doi: 10.1016/j.jadohealth.2011.11.004.

  PMID: 22265115 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Papillomavirus Infections

Interventions

human papillomavirus vaccine, L1 type 16, 18; Hepatitis A Vaccines

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; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2006
• First Posted: April 21, 2006
• Study Start: October 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: September 18, 2012
• Results First Posted: March 1, 2010

Record last verified: 2012-09

Locations

CO (2); HO (1); DE (22); TW (2); PA (1)