Booster immunisation of healthy children in the second year of life against poliomyelitis.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol. Subjects who received the complete three-dose primary vaccination course in study IPV-018. Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1. Written informed consent obtained from the par-ent(s)/LAR(s) of the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Are the trial subjects under 18? yes Number of subjects for this age range: 957 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: Child in care. Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1. For corticosteroids, this will mean prednisone > 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 or planned administration during the study period. Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 or planned administration during the study period. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study IPV-018. History of seizures or progressive neurological disease. 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 vaccine. Major congenital defects or serious chronic illness. Acute disease and/or fever at the time of enrolment. Fever is defined as temperature > 37.0°C on oral, axillary or tympanic setting and > 37. 5°C on rectal setting. The preferred route for recording tempera-ture in this study will be axillary. Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the safety and reactogenicity of a booster dose of GSK Biologicals’ IPV in terms of solicited and unsolicited, local and general symptoms and serious adverse events, in children primed with three doses of the same IPV vaccine in study IPV-018.;Primary end point(s): Immunogenicity with respect to components of the study vaccine (Anti-poliovirus types 1, 2 and 3 seroprotection status and antibody titres).;Timepoint(s) of evaluation of this end point: At 18 months of age for all the subjects (Day 0) One month after the booster dose for subjects in Poliorix group (Day 30). ;Main Objective: To assess the immunological response to a booster dose of GSK Biologicals’ IPV in terms of poliovirus type 1, 2 and 3 antibodies, one month after the booster dose in subjects primed with three doses of the same IPV vaccine in study IPV-018. To assess the persistence of antibodies to poliovirus types 1, 2 and 3 antigens at 18 months of age in subjects primed with three doses of GSK Biologicals’ IPV or three doses of OPV in study IPV-018. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of solicited local and general symptoms. Occurrence of unsolicited adverse events. Occurrence of serious adverse events. ;Timepoint(s) of evaluation of this end point: Occurrence of solicited local and general symptoms: During the 4-day (Day 0–3) follow-up after IPV booster vaccination for Poliorix Group. Occurrence of unsolicited adverse events: During the 31-day (Day 0–30) follow-up period after IPV booster vaccination in the Poliorix Group. Occurrence of serious adverse events: From the booster dose up to 30 days following vaccination. | — |
Countries
China
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed