Booster immunisation of healthy preschool children against diphtheria, tetanus, pertussis, poliomyelitis, mumps, measles and rubella
Conditions
Interventions
Trade Name: POLIOBOOSTRIX*1SIR 0,5ML S/AGO
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Diphtheria-pertussis-poliomyelitis-tetanus
Concentration unit: ml millilitre(s)
Concentra
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A male or female child of 5 and 6 years of age (up to, but excluding 7 years of age) at the time of vaccination. - Subjects who received a complete 3-dose vaccination with a DTPa-based combined vaccine according to a 3-5-11 month schedule in line with recommendations in Italy. The first two vaccine doses must have been administered before 9 months of age, the third dose must have been received between 10 and 18 months of age, and there must have been at least one month between each vaccination. - Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine in the second year of life, in line with recommendations in Italy. - Subjects who the investigator believes that their parents/guardians 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. - Written informed consent obtained from the parent or guardian 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: 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 (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent Inhaled and topical steroids are allowed. - Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, 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 (pharmaceutical product or device). - Previous booster vaccination against tetanus, diphtheria, pertussis and/or poliomyelitis since vaccination in the first two years of life. - Previous measles, mumps, rubella and/or varicella second dose vaccination. - Known history of diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps, rubella and/or varicella disease. - Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start. - Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination (no laboratory testing required). - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. - Administration of immunoglobulin and/or any blood products within the three months preceding vaccination or planned administration during the study period. - Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus. - Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine: Hypersensitivity reaction to any component of the vaccine; Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine; Fever ≥ 40C (axillary temperature/oral temperature) within 48 hours of vaccination, not due to another identifiable cause; Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination; Convulsions with or without fever, occurring within 3 days of vaccination. - Residence in the same household as a high risk person for varicella e.g.: Newborn infant (0-4 weeks of age) Pregnant women who have a negative history for chickenpox Persons with known immunodeficiency - The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met: Current febrile illness or axillary temperature ≥ 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that GSK Biologicals? dTpa-IPV vaccine is non-inferior to Sanofi-Pasteur-MSD?s DTPa-IPV vaccine, in terms of seroprotection rates against diphtheria, tetanus and poliovirus types 1, 2 and 3, one month after vaccination.;Primary end point(s): Immunogenicity one month after vaccination: Anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/ml Anti-poliovirus types 1, 2 and 3 antibody titres ≥ 8;Secondary Objective: To assess the immune response to the study vaccines in terms of percentages of subjects with booster response to diphtheria, tetanus, pertussis and polio antigens, one month after vaccination.To assess the immune response to the study vaccines in terms of antibody concentrations/titres against all vaccine antigens, one month after vaccination.To assess the immune response to the pertussis component of the study vaccines in terms of seropositivity rates, one month after vaccination.To assess the immune response to MMRV in terms of seroconversion rates, one month after vaccinination.To assess the safety and reactogenicity of the study vaccines in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events (SAEs). | — |
Countries
Italy
Outcome results
None listed