Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus Vaccine (Cervarix™) When Co-administered With GSK Biologicals' Hepatitis A Vaccine (Havrix®) in Healthy Female Adolescents Aged 9-14 Years

GlaxoSmithKline (GSK)

Status and phase: Withdrawn; Phase 3

Conditions: Infections, Papillomavirus

Treatments: Biological: Cervarix™; Biological: Havrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT02082639

117099

2012-004378-24 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the immunogenicity and safety of two doses of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine when co-administered with GSK Biologicals' HAV vaccine according to 0, 6 month schedule, compared to the administration of either of these vaccines alone. The study will ascertain that the immune responses elicited to the two vaccines are not adversely impacted compared to when HPV-16/18 L1 VLP AS04 vaccine and HAV vaccine are administered alone.

Sex: Female

Ages: 9 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A female between, and including, 9 and 14 years of age at the time of the first vaccination.

• Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

• Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrollment.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

• Female subjects of non-childbearing potential may be enrolled in the study.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.

Exclusion criteria

• Child in care.

• Use of any investigational or non-registered product 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. Inhaled and topical steroids are allowed.

• Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and 30 days after the first dose of vaccine with the exception of routine vaccines such as meningococcal, pertussis, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine.

• Concurrently participating in another clinical study, at any time during the study period (up to Month 12), in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

• Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (up to Month 12).

• Previous administration of MPL or AS04 adjuvant.

• Previous vaccination against hepatitis A or planned administration of any hepatitis A vaccine other than that foreseen by the study protocol during the study period (up to Month 12).

• Cancer or autoimmune disease under treatment.

• History of hepatitis A infection.

• Known exposure to hepatitis A within the previous 6 weeks.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.

• Hypersensitivity to latex.

• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator preclude administration of the study vaccine.

• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period (up to Month 12).

• Acute disease and/or fever at the time of enrollment.

  • Fever is defined as temperature ≥ 37.0°C for oral, axillary or tympanic route. The preferred route for recording temperature in this study will be oral or axillary.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

HPV Group

Experimental group

Description:

Subjects will receive two doses of HPV vaccine intramuscularly

Treatment:

Biological: Cervarix™

HAV Group

Experimental group

Description:

Subjects will receive two doses of HAV vaccine intramuscularly

Treatment:

Biological: Havrix

HPV+HAV Group

Experimental group

Description:

Subjects will receive two doses of both HPV and HAV vaccines intramuscularly

Treatment:

Biological: Cervarix™

Biological: Havrix