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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Papillomavirus Vaccines

Infections, Papillomavirus

Treatments

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

Biological: Engerix™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00637195

2007-007876-41 (EudraCT Number)

111567

Details and patient eligibility

About

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.

Enrollment

152 patients

Sex

Female

Ages

20 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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
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)

152 participants in 2 patient groups

Cervarix™ & Engerix™ Group

Experimental group

Description:

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).

Treatment:

Biological: Engerix™

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

Engerix™ Group

Active Comparator group

Description:

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

Treatment:

Biological: Engerix™