To induce appropriate protection against pneumococcal disease. To assess non-inferiority of OPA response for serotype 19A after booster dose of PCV13 administered between 11-12 months of age in subjects primed with 10Pn-PD-DiT vs those primed with PCV13.
Conditions
Interventions
Sponsors
BIOVOMED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy ALL the following criteria at study entry: • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). • Written informed consent obtained from the parents/LAR(s) of the subject. • Healthy subjects as established by medical history and clinical examination before entering into the study. • Subjects between and including 11 to 12 months of age at the time of vaccination for booster dose with PCV13. • Previously completed two-dose vaccination course till month 6 with either 10Pn-PD-DiT for Group 10Pn-PD-DiT or PCV13 for Group PCV13. Are the trial subjects under 18? yes Number of subjects for this age range: 92 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: The following criteria should be checked at the time of study entry for all subjects. If ANY exclusion criterion applies, the subject must not be included in the study: • Child in care (A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.) • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. • Chronic administration (defined as more than 14 days in total) 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. • Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before the dose and ending 30 days after the dose of vaccine(s), with the exception of licensed influenza vaccines and licensed DTP vaccines. The licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines. Administration of any of the vaccines mentioned above has to be documented in the "Concomitant vaccination" of the CRF (Case Record Form). • 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 S. pneumoniae. • 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. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). • Major congenital defects or serious chronic illness. • History of any neurological disorders or seizures. • Acute disease and/or fever at the time of enrolment. Subjects with temperature bellow 37.5°C on oral, axillary or tympanic setting, or bellow 38.0°C on rectal setting and subjects with mild disease without fever e.g mild diarrhea or mild URTI may be enrolled at the discreation of the investigator. • Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during study period. • Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator. • Anaphylaxis following previous administration of a pneumococcal conjugate vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess non-inferiority of OPA response for serotype 19A after booster dose of PCV13 administered between 11-12 months of age in subjects primed with 10Pn-PD-DiT vs those primed with PCV13.;Secondary Objective: To assess non-inferiority of antibody response for serotype 19A after booster dose of PCV13 administered between 11-12 months of age in subjects primed with 10Pn-PD-DiT vs those primed with PCV13. To assess antibody and OPA responses one month after booster dose of PCV13 administered between 11-12 months of age for serotypes in 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. To assess the antibody persistence and OPA 12 months following the PCV booster dose for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. To evaluate safety and reactogenicity of the booster dose of PCV13 given at 11-12 months;Primary end point(s): To assess non-inferiority of OPA response for serotype 19A after booster dose of PCV13 administered between 11-12 months of age in subjects primed with 10Pn-PD-DiT vs those primed with PCV13. • Opsonophagocytic activity (titres) against vaccine pneumococcal serotype 19A one month after booster dose.;Timepoint(s) of evaluation of this end point: Month 1 ± 14 days (Age 12-13 months) Months 12 ± 14 days (Age 23-24 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess non-inferiority of antibody response for serotype 19A after booster dose of PCV13 administered between 11-12 months of age in subjects primed with 10Pn-PD-DiT vs those primed with PCV13. • Concentrations of antibodies against vaccine pneumococcal serotype 19A one month after booster dose. • Concentrations of antibodies against vaccine pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F one month after booster dose. • Opsonophagocytic activity (titres) against vaccine pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F one month after booster dose. • Concentrations of antibodies against vaccine pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F 12 months after booster dose. • Opsonophagocytic activity against vaccine pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 12 months after booster dose. Safety and reactogenicity: • Occurrence of each solicited adverse event within 4 days after booster vaccination with PCV13. - Local (any, grade 3) adverse events (Day 0-3) - General (any, grade 3, related) adverse events (Day 0-3) • Occurrence of unsolicited adverse events within 31 days (Day 0-30) after booster vaccination with PCV13. • Occurrence of serious adverse events during the entire study period.;Timepoint(s) of evaluation of this end point: Immunogenicity Month 1 ± 14 days (Age 12-13 months) Months 12 ± 14 days (Age 23-24 months) Safety 30 minutes, 4 days, 30 days, follow-up | — |
Countries
Slovakia
Contacts
Public ContactIngrid Urbancikova
Children Faculty Hospital Košice
Outcome results
None listed