Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

NCT ID: NCT00578227

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 814 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-15
• Study Completion Date: 2009-04-28

Brief Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.

Conditions

Infections, Papillomavirus

Study Design

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

Study Groups

Cervarix™ & Twinrix™ Group

Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).

Group Type: EXPERIMENTAL

Cervarix™

Intervention Type: BIOLOGICAL

Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

Twinrix ™ Paediatric

Intervention Type: BIOLOGICAL

Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

Cervarix™ Group

Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).

Group Type: EXPERIMENTAL

Cervarix™

Intervention Type: BIOLOGICAL

Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

Twinrix™ Group

Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).

Group Type: ACTIVE_COMPARATOR

Twinrix ™ Paediatric

Intervention Type: BIOLOGICAL

Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

Interventions

Cervarix™

Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

Intervention Type: BIOLOGICAL

Twinrix ™ Paediatric

Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

Intervention Type: BIOLOGICAL

Other Intervention Names

HPV vaccine; GSK Biologicals' HPV-16/18 L1 AS04

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that they and/or their legally acceptable representatives (LARs) can and will comply with the requirements of the protocol should be enrolled in the study.
• A female between, and including, 9 and 15 years of age (has not attained her 16th birthday) at the time of the first vaccination.
• 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 the subject's LAR, and written informed assent must be obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects must not be pregnant.
• Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent or use adequate contraception for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
• Concurrently participating in another clinical study, at any time during the study period (up to the Month 12 telephone contact), 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 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(s). Administration of routine vaccines may be allowed up to 8 days before the first dose
• A subject planning to become pregnant, likely to become pregnant 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 A or B planned administration of any hepatitis A or B vaccine other than that foreseen by the study protocol during the study period.
• History of hepatitis A or B infection.
• Known exposure to hepatitis A or 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
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 15 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

Surrey, British Columbia, Canada

GSK Investigational Site

Brampton, Ontario, Canada

GSK Investigational Site

Greater Sudbury, Ontario, Canada

GSK Investigational Site

Newmarket, Ontario, Canada

GSK Investigational Site

Sarnia, Ontario, Canada

GSK Investigational Site

Hoersholm, , Denmark

GSK Investigational Site

Odense C, , Denmark

GSK Investigational Site

Bordány, , Hungary

GSK Investigational Site

Budapest, , Hungary

GSK Investigational Site

Budapest, , Hungary

GSK Investigational Site

Budapest, , Hungary

GSK Investigational Site

Budapest, , Hungary

GSK Investigational Site

Győr, , Hungary

GSK Investigational Site

Hódmezővásárhely, , Hungary

GSK Investigational Site

Szeged, , Hungary

GSK Investigational Site

Szombathely, , Hungary

GSK Investigational Site

Karlskrona, , Sweden

GSK Investigational Site

Linköping, , Sweden

GSK Investigational Site

Lycksele, , Sweden

GSK Investigational Site

Örebro, , Sweden

GSK Investigational Site

Umeå, , Sweden

Countries

Canada; Denmark; Hungary; Sweden

References

Pedersen C, Breindahl M, Aggarwal N, Berglund J, Oroszlan G, Silfverdal SA, Szuts P, O'Mahony M, David MP, Dobbelaere K, Dubin G, Descamps D. Randomized trial: immunogenicity and safety of coadministered human papillomavirus-16/18 AS04-adjuvanted vaccine and combined hepatitis A and B vaccine in girls. J Adolesc Health. 2012 Jan;50(1):38-46. doi: 10.1016/j.jadohealth.2011.10.009.

Reference Type: BACKGROUND

PMID: 22188832 (View on PubMed)

Pederson C et al. Co-administration of ASO4- adjuvanted human papillomavirus- 16/18 cervical cancer vaccine with inactivated hepatitis A ans B vaccine in girls aged 9-15 years. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Beunos Aires, Argentina, 19-22 November 2009.

Reference Type: BACKGROUND

Study Documents

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

110886

Identifier Type: -

Identifier Source: org_study_id