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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Infections, Papillomavirus

Treatments

Biological: HPV Vaccine (GSK580299) Cervarix TM

Biological: Engerix B

Study type

Interventional

Funder types

Industry

Identifiers

NCT00652938

111507

Details and patient eligibility

About

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.

Enrollment

744 patients

Sex

Female

Ages

9 to 15 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

744 participants in 3 patient groups

Cervarix & Engerix Group

Active Comparator group

Description:

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.

Treatment:

Biological: HPV Vaccine (GSK580299) Cervarix TM

Biological: Engerix B

Cervarix Group

Experimental group

Description:

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

Treatment:

Biological: HPV Vaccine (GSK580299) Cervarix TM

Engerix Group

Active Comparator group

Description: