Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)

NCT00637195 | Completed Phase 3 Results

• 2 other identifiers: 1115672007-007876-41
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

Brief Summary

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and safety of a commercially available vaccine co-administered with GlaxoSmithKline Biologicals' HPV vaccine GSK580299 in healthy female subjects.

Conditions

Infections, Papillomavirus; Papillomavirus Vaccines

Keywords

Human papillomavirus (HPV) vaccine; Hepatitis B; Cervical cancer; HPV; Papillomavirus

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix

  A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).

  Month 3

• Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix

  Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).

  Month 3

Secondary Outcomes (13)

• Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies

  Months 2 and 7

• Anti-HPV-16/18 Antibody Titers

  Months 2 and 7

• Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies

  Months 2, 3 and 13

• Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course

  Months 2 and 13

• Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course

  At Months 2 and 13

Study Arms (2)

Cervarix™ & Engerix™ Group

EXPERIMENTAL

Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).

Biological: Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™); Biological: Engerix™

Engerix™ Group

ACTIVE COMPARATOR

Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).

Biological: Engerix™

Interventions

Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) BIOLOGICAL

Intramuscular administration, 3 doses.

Also known as: GSK Biologicals' HPV vaccine 580299

Cervarix™ & Engerix™ Group

Engerix™ BIOLOGICAL

Intramuscular administration, 4 doses.

Also known as: GSK Biologicals' vaccine 103860

Cervarix™ & Engerix™ Group; Engerix™ Group

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• A female between, and including, 20 and 25 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history and history directed clinical examination before entering into the study.
• Subjects must not be pregnant.
• Subjects must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine. Administration of routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine is allowed.
• Concurrently participating in another clinical study, at any time during the study period (up to Month 13), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
• Pregnant or breastfeeding women.
• Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period
• Previous administration of components of the investigational vaccine.
• Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period.
• History of hepatitis B infection.
• Known exposure to hepatitis B within the previous 6 weeks.
• Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
• Cancer or autoimmune disease under treatment.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

La Louvière, 7100, Belgium

Location

Related Publications (2)

• Leroux-Roels G, Haelterman E, Maes C, Levy J, De Boever F, Licini L, David MP, Dobbelaere K, Descamps D. Randomized trial of the immunogenicity and safety of the Hepatitis B vaccine given in an accelerated schedule coadministered with the human papillomavirus type 16/18 AS04-adjuvanted cervical cancer vaccine. Clin Vaccine Immunol. 2011 Sep;18(9):1510-8. doi: 10.1128/CVI.00539-10. Epub 2011 Jul 6.

  PMID: 21734063 BACKGROUND

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Papillomavirus Infections; Hepatitis B; Uterine Cervical Neoplasms

Interventions

human papillomavirus vaccine, L1 type 16, 18; Engerix-B

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Hepadnaviridae Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

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: February 28, 2008
• First Posted: March 17, 2008
• Study Start: March 11, 2008
• Primary Completion: June 20, 2008
• Study Completion: June 18, 2009
• Last Updated: January 3, 2020
• Results First Posted: December 18, 2009

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

BE (2)