Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects

NCT ID: NCT00652938

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 744 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-09
• Study Completion Date: 2010-01-08

Brief Summary

Infection with human papillomavirus (HPV) has been clearly established as the necessary 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. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) vaccine as compared to the administration of either vaccine alone.

Conditions

Infections, Papillomavirus

Study Design

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

Study Groups

Cervarix & Engerix Group

Subjects received 3 doses of Cervarix™ (Human Papillomavirus \[HPV\] vaccine) co-administered with Engerix™ (Hepatitis B \[HBV\] vaccine) according to a 0, 1, 6-month schedule.

Group Type: ACTIVE_COMPARATOR

HPV Vaccine (GSK580299) Cervarix TM

Intervention Type: BIOLOGICAL

IM administration

Engerix B

Intervention Type: BIOLOGICAL

IM administration

Cervarix Group

Subjects received 3 doses of Cervarix™ (Human Papillomavirus \[HPV\] vaccine) according to a 0, 1, 6-month schedule.

Group Type: EXPERIMENTAL

HPV Vaccine (GSK580299) Cervarix TM

Intervention Type: BIOLOGICAL

IM administration

Engerix Group

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

Group Type: ACTIVE_COMPARATOR

Engerix B

Intervention Type: BIOLOGICAL

IM administration

Interventions

HPV Vaccine (GSK580299) Cervarix TM

IM administration

Intervention Type: BIOLOGICAL

Engerix B

IM administration

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that they and/or their parents/legally acceptable representatives (LARs) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) 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's parent/LAR prior to the enrolment. In addition, 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. Absence of pregnancy should be verified with a urine pregnancy test.
• If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for at least 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche (begin menstruating) during the study, and therefore become of childbearing potential, must agree to follow the same precautions.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
• 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 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).
• 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.
• 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

Nijmegen, , Netherlands

GSK Investigational Site

Rotterdam, , Netherlands

GSK Investigational Site

Linköping, , Sweden

GSK Investigational Site

Luleå, , Sweden

GSK Investigational Site

Malmo, , Sweden

GSK Investigational Site

Norrköping, , Sweden

GSK Investigational Site

Skene, , Sweden

Countries

Netherlands; Sweden

References

Schmeink C et al. Co-administration of AS04-adjuvanted human papillomavirus-16/18 vaccine with hepatitis B vaccine in healthy female subjects aged 9-15 years. Abstract presented at the 28th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.

Reference Type: BACKGROUND

Schmeink CE, Bekkers RL, Josefsson A, Richardus JH, Berndtsson Blom K, David MP, Dobbelaere K, Descamps D. Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine: randomized study in healthy girls. Vaccine. 2011 Nov 15;29(49):9276-83. doi: 10.1016/j.vaccine.2011.08.037. Epub 2011 Aug 19.

Reference Type: BACKGROUND

PMID: 21856349 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

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

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Document Type: Dataset Specification

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

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Document Type: Study Protocol

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

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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: Individual Participant Data Set

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

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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

111507

Identifier Type: -

Identifier Source: org_study_id