vaccin against the human papillomavirus MedDRA version: 17.0 Level: LLT Classification code 10046859 Term: Vaccination System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Cervarix
Product Name: cervarix
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: HUMAN PAPILLOMAVIRUS VACCINE
Other descriptive name: HUMAN PAPILLOM
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects who the investigator believes can and will comply with the requirements of the protocol and who the investigator believes their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol. • A female between, and including, 9 and 13 years of age at the time of the first vaccination. • Written informed consent obtained from the subject and from the parent(s) or LAR(s) of the subject prior to enrolment in the study. • Healthy subjects as established by medical history and clinical examination before entering into the study. • To avoid the chance of previous exposure to HPV (any genotype, and HPV-16 and 18 in particular) participants should not have had sexual intercourse (virgin) or other intimate sexual experience) • Participants of childbearing potential may be enrolled in the study, if the subject: ? has a negative pregnancy test on the day of vaccination ? has agreed to continue abstinence during the entire study period and for two months after completion of the vaccination series. Are the trial subjects under 18? yes Number of subjects for this age range: 14 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant or breastfeeding. • Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than those foreseen in the protocol. • Use of any investigational or non-registered product (drug or vaccine) 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 6). • Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine/product dose. For corticosteroids, this will mean prednisone = 20mg/day or equivalent. Inhaled and topical steroids are allowed. • History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines. • Cancer or autoimmune disease under treatment. • Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of study vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. • Previous administration of MPL or AS04 adjuvant. • 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. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • Family history of congenital or hereditary immunodeficiency. • Major congenital defects or serious chronic illness. • 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 precludes administration of the study vaccine. • Acute disease and/or fever at the time of enrolment. ? Fever is defined as a temperature of = 37.5°C (99.5°F) measured orally or axillary ? Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. If deemed necessary by the investigator, enrolment will be deferred until condition is resolved.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To define and compare the usage of VDJ and VJ segments in the immunoglobulin heavy (VH) and light (VL) heavy and light chains, respectively, of plasmablasts induced after the 2nd dose of Cervarix and Gardasil. •To examine and compare the mutational diversity that occurs following vaccine-induced affinity maturation in plasmablasts induced after the 2nd dose of Cervarix and Gardasil. ;Secondary Objective: •To evaluate the cross-reactive pattern of polyclonal serum antibodies generated after the 2nd of a two-dose schedule of Cervarix or Gardasil, given to pairs of twin sisters aged between 9 and 13 years of age, using ELISA- or PBNA-assays. •To compare the VDJ and VJ segment usage and affinity maturation in HPV-specific antibodies generated after the 2nd dose of a two-dose schedule of either Cervarix or Gardasil, administered to pairs of twin sisters aged between 9 and 13 years of age. •To compare the cross-reactive potential of monoclonal antibodies obtained by eukaryotic expression of a series of heavy (VH) and light (VL) chains from single ASC isolated after the 2nd dose of a two-dose schedule of either Cervarix or Gardasil, administered to pairs of twin sisters aged between 9 and 13 years of age. ;Primary end point(s): phone call to verify that subjects had no major adverse events: safety follow-up call ;Timepoint(s) of evaluation of this end point: 365 days after the first vaccin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): blood samples for antibody determination/B lymphocyte analyses;Timepoint(s) of evaluation of this end point: 7 days after vaccin 2 | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hopspital
Outcome results
None listed