Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine

NCT ID: NCT00316693

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1046 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-26
• Study Completion Date: 2009-02-10

Brief Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go 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. This study will evaluate the efficacy in prevention of persistent HPV-16 or HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 - 25 years of age at study start. Approximately 1000 study subjects will either receive the HPV vaccine or a control vaccine (Hepatitis A 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.

Detailed Description

The Protocol Posting has been updated to reflect changes as a consequence of an amendment to the protocol. Sections impacted are Official Title of the study and Intervention name.

Conditions

Infections, Papillomavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cervarix Group

Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.

Group Type: EXPERIMENTAL

HPV-16/18 vaccine (Cervarix™)

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Aimmugen Group

Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.

Group Type: ACTIVE_COMPARATOR

Aimmugen™

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Interventions

HPV-16/18 vaccine (Cervarix™)

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Aimmugen™

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator/co-investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• A Japanese female subject between, and including, 20 and 25 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject prior to enrolment.
• Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
• Subjects must have a negative urine pregnancy test.
• Subjects must be of non-childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
• Subject must have an intact cervix

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine/control within 30 days preceding the first dose of study vaccine/control, or planned use during the study period.
• Pregnant or breastfeeding women. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.
• A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to 2 months after the last vaccine dose
• previous administration of components of the investigational vaccine
• 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 the first dose of vaccine. Routine vaccines may be allowed up to 8 days before the first dose of study vaccine.
• Previous vaccination against HPV.
• History of vaccination against hepatitis A or a known clinical history of hepatitis A disease
• Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
• History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines
• Hypersensitivity to latex
• Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
• Cancer or autoimmune disease under treatment.
• History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.
• Heavy bleeding or heavy vaginal discharge such that a pelvic examination can not be performed
• Acute disease at the time of enrolment.
• Oral temperature >= 37.5°C / axillary temperature > 37.5°C.
• 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).

• Minimum Eligible Age: 20 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

Kagoshima, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

, ,

Countries

Japan

References

Konno R, Dobbelaere KO, Godeaux OO, Tamura S, Yoshikawa H. Immunogenicity, reactogenicity, and safety of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women: interim analysis of a phase II, double-blind, randomized controlled trial at month 7. Int J Gynecol Cancer. 2009 Jul;19(5):905-11. doi: 10.1111/IGC.0b013e3181a23c0e.

Reference Type: BACKGROUND

PMID: 19574783 (View on PubMed)

Konno R, Tamura S, Dobbelaere K, Yoshikawa H. Efficacy of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women aged 20 to 25 years: interim analysis of a phase 2 double-blind, randomized, controlled trial. Int J Gynecol Cancer. 2010 Apr;20(3):404-10. doi: 10.1111/IGC.0b013e3181d373a5.

Reference Type: BACKGROUND

PMID: 20375805 (View on PubMed)

Konno R, Tamura S, Dobbelaere K, Yoshikawa H. Prevalence and type distribution of human papillomavirus in healthy Japanese women aged 20 to 25 years old enrolled in a clinical study. Cancer Sci. 2011 Apr;102(4):877-82. doi: 10.1111/j.1349-7006.2011.01878.x. Epub 2011 Feb 17.

Reference Type: BACKGROUND

PMID: 21251162 (View on PubMed)

Konno R et al. Efficacy, immunogenicity and safety of HPV 16/18 AS04-adjuvanted vaccine in Japanese women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.

Reference Type: BACKGROUND

Konno R et al. Interim analysis of clinical trial of HPV-16/18-AS04 vaccine in Japan. Abstract presented at the 25th International Papillomavirus Conference, Malmö, Sweden, 8-14 May 2009.

Reference Type: BACKGROUND

Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

Reference Type: BACKGROUND

PMID: 18845199 (View on PubMed)

Chen J, Gopala K, Akarsh PK, Struyf F, Rosillon D. Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine. Open Forum Infect Dis. 2019 Dec 4;6(12):ofz486. doi: 10.1093/ofid/ofz486. eCollection 2019 Dec.

Reference Type: DERIVED

PMID: 31824976 (View on PubMed)

Konno R, Yoshikawa H, Okutani M, Quint W, V Suryakiran P, Lin L, Struyf F. Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women. Hum Vaccin Immunother. 2014;10(7):1781-94. doi: 10.4161/hv.28712.

Reference Type: DERIVED

PMID: 25424783 (View on PubMed)

Konno R, Tamura S, Dobbelaere K, Yoshikawa H. Efficacy of human papillomavirus type 16/18 AS04-adjuvanted vaccine in Japanese women aged 20 to 25 years: final analysis of a phase 2 double-blind, randomized controlled trial. Int J Gynecol Cancer. 2010 Jul;20(5):847-55. doi: 10.1111/IGC.0b013e3181da2128.

Reference Type: DERIVED

PMID: 20606533 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

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

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Document Type: Statistical Analysis Plan

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: Dataset Specification

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

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Related Links

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Other Identifiers

104798

Identifier Type: -

Identifier Source: org_study_id