Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Infections, Papillomavirus

Treatments: Biological: Cervarix; Biological: Engerix-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00534638

106636

2007-001731-55 (EudraCT Number)

Details and patient eligibility

About

Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and women. The most important disease associated with oncogenic HPV infection is cervical cancer, currently the second leading cause of cancer-related death among women globally. The current study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15 years of age.

Enrollment: 34,412 patients

Sex: All

Ages: 12 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Study participants who the investigator or delegate believes that they and/or their parents/legally acceptable representative 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 male or female between, and including, 12 and 15 years of age at the time of the first vaccination.

A written informed assent must be obtained from all study participants prior to enrolment. In addition, a written informed consent must be obtained from the study participants' parent or legally acceptable representative.

Note: As according to the Finnish law legal age of consent is 15 years, a written informed consent form can be obtained from study participants aged 15 years old and their parent(s)/legally acceptable representative(s) will receive a letter informing them of their child participation to the study.

• Healthy male and female study participants as established by medical history before entering into the study. If needed, a history-directed clinical examination will be performed by the investigator or delegate (e.g. study nurse).
• Study participants must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per investigator's or delegate's clinical judgement.
• If the study participant is female, she must be of non-childbearing potential, i.e. be abstinent, have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal or pre-menarcheal, or if she is of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.

Exclusion criteria

• Previous vaccination against HPV or Hepatitis B virus.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).)
• Pregnant or lactating female.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34,412 participants in 3 patient groups

Cervarix/Engerix-B A Group

Experimental group

Description:

The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Treatment:

Biological: Engerix-B

Biological: Cervarix

Cervarix/Engerix-B B Group

Experimental group

Description:

The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Treatment:

Biological: Engerix-B

Biological: Cervarix

Engerix-B Group

Active Comparator group

Description:

In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Treatment:

Biological: Engerix-B