Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents
Trial overview
Number of female subjects with overall vaccine effectiveness against genital infection with Human Papilloma Virus (HPV)-16/18 types in Cervarix/Engerix-B B Group versus Engerix-B Group and in Cervarix/Engerix-B A Group versus Engerix-B Group
Timeframe: At the time of Visit 5 (i.e. at 18.5 years of age)
Number of female subjects with overall vaccine effectiveness against genital infection with HPV-16/18 types in Cervarix/Engerix-B A Group versus Cervarix/Engerix-B B Group
Timeframe: At the time of Visit 5 (i.e. at 18.5 years of age)
Number of female subjects with overall vaccine effectiveness against genital oncogenic infection with specific HPV types
Timeframe: At the time of Visit 5 (i.e. at 18.5 years of age)
Number of female subjects with total vaccine effectiveness against oropharyngeal infection with HPV-16/18 types
Timeframe: At the time of Visit 5 (i.e. at 18.5 years of age)
Number of female subjects with total vaccine effectiveness against oropharyngeal oncogenic infection with specific HPV types
Timeframe: At the time of Visit 5 (at 18.5 years of age)
Number of male subjects reporting any and Grade 3 solicited local symptoms, in a subset of subjects
Timeframe: During the 7-day post-vaccination period following each dose and across doses
Number of male subjects reporting any, Grade 3 and related to vaccination solicited general symptoms, in a subset of subjects
Timeframe: During the 7-day post-vaccination period following each dose and across doses
Number of male subjects reporting any, Grade 3 and related to vaccination unsolicited adverse events (AEs), in a subset of subjects
Timeframe: Within the 30-day post-vaccination period
Number of male subjects with urticaria/rash within 30 minutes after each vaccination dose, in a subset of subjects
Timeframe: Within 30 minutes following each vaccination dose
Number of male subjects reporting medically significant conditions (MSCs), in a subset of subjects
Timeframe: From Dose 1 (at Day 0) until Month 12
Number of male subjects reporting any serious adverse events (SAEs) and SAEs causally related to vaccination, in a subset of subjects
Timeframe: From Dose 1 (at Day 0) until Month 12
Number of subjects reporting SAEs assessed by the investigator as possibly related to vaccination
Timeframe: During the entire study period (from Day 0 up to Visit 5 [18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
Number of subjects with new onset of autoimmune diseases (NOADs), retrieved from Care Register for Social Welfare and Health Care (HILMO)
Timeframe: During the entire study period (from day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
Number of subjects reporting pregnancies and outcomes of reported pregnancies with onset during the study period, retrieved from Medical Birth Registry and HILMO
Timeframe: During the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
Number of subjects with HPV-16 and HPV-18 antibody concentrations equal to or above the cut-off values, by gender, in a subset of subjects
Timeframe: At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age)
Anti-HPV-16 and anti-HPV-18 antibody concentrations, by gender, in a subset of subjects
Timeframe: At the time of Visit 1 (Day 0), Visit 4 (at Month 7) and at the time of Visit 5 (18.5 years of age)
Participation 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.
- Previous vaccination against HPV or Hepatitis B virus.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- 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.
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.
- 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.
Previous vaccination against HPV or Hepatitis B virus.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.