The study is to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Human Papillomavirus (HPV) vaccine (GSK580299) in healthy female subjects 10-25 years of age (inclusive).

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2017-000416-42-Outside-EU/EEA
• Date of registration: 15/09/2017
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: The study is to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Human Papillomavirus (HPV) vaccine (GSK580299) in healthy female subjects 10-25 years of age (inclusive).
• Scientific title: A phase IIIb, double-blind, randomized, controlled, multicentre study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 months) in healthy female subjects aged 10-25 years. - HPV-021
• Target sample size: 676
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000416-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Senegal, Tanzania, United Republic of

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion criteria

Inclusion criteria:
• Subjects who the investigator believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., return for follow-up visits) should be enrolled in the study.
• A female between, and including, 10 and 25 years of age at the time of the first vaccination.
• Written or oral, signed or thumb printed or witnessed informed consent obtained from the subject prior to enrolment.

For subjects below legal age of consent, written or oral, signed or thumb printed or witnessed informed consent obtained from the subject’s parent or legally acceptable representative. In addition, a written or oral, signed or thumb printed and witnessed informed assent must be obtained from the subject.
• Free of obvious health problems as established by medical history, clinical examination and laboratory testing before entering into the study.
• Subjects must have a negative urine pregnancy test at the screening visit and at Visit 1 (Day 0).
• Subjects must be seronegative for human immunodeficiency virus (HIV) at the screening visit.
• Subjects must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine con-traceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant or DepoProvera; progestogen-only implantable cutaneous hormonal patch or injectable con-traceptives) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.
• Subjects must have had no more than 6 sexual partners prior to enrolment.
• Subjects must be willing to undergo HIV voluntary counselling and testing (VCT) and must be willing to be in-formed of their HIV status.

Subjects below legal age of consent must also be willing to have their parent or legally acceptable representative informed of their HIV status.

Are the trial subjects under 18? yes
Number of subjects for this age range: 454
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 222
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period. (For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
• Administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. Enrolment will be deferred until the subject is outside of specified window.
• Planned administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. Days 0 - 29) any dose of study vaccine.
• Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Month 0 to 12).
• Previous administration of MPL or AS04 adjuvant.
• Cancer or autoimmune disease under treatment.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection based on laboratory testing performed during the screening visit.
• Hypersensitivity to latex (found in syringe-tip cap and plunger).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control (e.g. aluminium, MPL).
• 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 ill-ness, i.e., Oral temperature/axillary temperature =< 37.5°C).
• Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit.
• History of any neurologic disorders or seizures.
• 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.
• Pregnant or breastfeeding female.
• A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose (i.e. up to Month 8).
• 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 product (pharmaceutical product or device).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Healthy volunteers [For active immunisation of healthy adolescents and young adult females from the age of 10 to 25 years for the prevention of persistent infection, premalignant genital (cervical, vulvar and vaginal) lesions and cervical, vulvar and vaginal cancers (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic Human Papillomaviruses (HPV) types 16 and 18].

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Trade Name: CERVARIX
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Current Sponsor code: HPV-16 L1
Other descriptive name: HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: -
Current Sponsor code: HPV-18 L1
Other descriptive name: HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Suspension for injection in pre-filled syringe
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)

Secondary Objective: • To evaluate antibody responses (ELISA) against HPV-16 and HPV-18 in all subjects at Month 2 and Month 12.
• To evaluate the safety and reactogenicity of the study vaccine in all subjects throughout the entire study period.

Primary end point(s): Number of seroconverted subjects for anti-HPV-16 and anti-HPV-18 antibodies.
Geometric mean titers (GMTs) for anti-HPV-16 and anti-HPV-18 antibodies.

Main Objective: • To evaluate antibody responses enzyme-linked immunosorbent assay (ELISA) against HPV-16 and HPV-18 at Month 7 in subjects 15-25 years of age.
• To evaluate the antibody responses against HPV-16 and HPV-18 at Month 7 in subjects 10-14 years of age.

Timepoint(s) of evaluation of this end point: At Month 7

Secondary Outcome(s)

Secondary end point(s): 1. HPV-16 and HPV-18 seroconversion rates and GMTs in all subjects.
2. Number of subjects with any and Grade 3 solicited local symptoms
3. Number of subjects with any, Grade 3 and related solicited general symptoms
4. Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
5. Number of subjects with new onset of chronic disease (NOCDs) and other medically significant conditions (MSCs)
6. Number of subjects with serious adverse events (SAEs)
7. Number of subjects with pregnancies and their outcomes
8. Number of Senegalese subjects with clinically relevant abnormalities in biochemical and haematological parameters
9. Number of Tanzanian subjects with clinically relevant abnormalities in biochemical and haematological parameters

Timepoint(s) of evaluation of this end point: 1. At Month 2 and Month 12
2. Within 7 days (Days 0-6) after each and any vaccination
3. Within 7 days (Days 0-6) after each and any vaccination
4. Within 30 days (Days 0-29) after any vaccination
5. From Day 0 up to Month 7 and from Month 7 up to Month 12
6. From Day 0 up to Month 7 and from Month 7 up to Month 12
7. From Day 0 up to Month 7
8. At Day 0, Month 7 and Month 12
9. At Month 7 and Month 12

Secondary ID(s)

106069

Source(s) of Monetary Support

GlaxoSmithKline Biologicals