Primary immunisation of healthy infants in the first year of life against poliomyelitis
Conditions
Interventions
Trade Name: Trivalent Oral Poliomyelitis vaccine (live, attenuated), Sabin strains
Product Name: Oral Poliomyelitis Vaccine
Product Code: OPV
Pharmaceutical Form: Oral suspension
INN or Proposed INN:
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination. Born after a gestation period of 36 to 42 weeks inclusive. Subjects who the investigator believes that their par-ents/Legally Acceptable Representative [(LAR) (s)] can and will comply with the requirements of the protocol. Written informed consent obtained from the par-ents/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: 1101 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: Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs since birth. 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 since birth or planned administration during the study period. Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP, Hib and/or hepatitis B vaccines. 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 or intercurrent poliomyelitis disease or vaccination. History of seizures or progressive neurological disease. Any confirmed or suspected immunosuppressive or im-munodeficint condition, based on medical history and physical examination. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. Major congenital defects or serious chronic illness. Child in care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of GSK Biologicals’ IPV vaccine as compared to the Chinese OPV vaccine in terms of the immune response to poliovirus type 1, 2 and 3, one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to the three poliovirus antigens will be demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference [Control Group minus Poliorix Group] in the percentage of seroprotected subjects is less than or equal to 10%.;Secondary Objective: To assess the pre-existing immunity to the poliovirus types 1, 2 and 3 in terms of seroprotection status and GMTs, prior to the first vaccine dose. To assess the immune response to the study vaccines in terms of GMTs of antibodies to poliovirus types 1, 2 and 3, one month after the third vaccine dose. To assess the safety and reactogenicity of the study vaccines in terms of solicited, unsolicited, local and general symptoms and serious adverse events.;Primary end point(s): Immunogenicity with respect to the components of the study vaccines (Anti-poliovirus types 1, 2 and 3 seroprotection status). ;Timepoint(s) of evaluation of this end point: One month after the third dose of primary vaccination (Month 3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity with respect to the components of the study vaccines (Anti-poliovirus types 1, 2 and 3 seroprotection status). Occurrence of solicited local and general symptoms. Occurrence of unsolicited symptoms. Occurrence of serious adverse events (SAEs).;Timepoint(s) of evaluation of this end point: Immunogenicity with respect to the components of the study vaccines: Prior to first dose and one month after the third dose of primary vaccination (Day 0 and Month 3 respectively). Occurrence of solicited local and general symptoms: During the 4-day (Day 0–3) follow-up period following each dose of the study vaccines. Occurrence of unsolicited symptoms:During the 31-day (Day 0–30) follow-up period following each dose of the study vaccines. Occurrence of serious adverse events (SAEs): From Dose 1 up to study end (Day 0 to Month 3). | — |
Countries
China
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed