Immunogenicity of alternate and reduced immunization schedules using the regular thirteen-valent polysaccharide conjugate vaccine against infection with Streptococcus pneumoniae
Conditions
Interventions
Trade Name: Prevenar 13
Product Name: Prevenar 13 (PCV13)
Product Code: Prevenar 13 (PCV13)
Pharmaceutical Form: Suspension for injection
Sponsors
CIB/RIVM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Infants in good general health, eligible to be vaccinated according to the Dutch national vaccination program. The same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with small increases in temperature or cold are seen as children with normal health. • The parents have to be willing and able to allow their child to participate in the trial according to the described procedures • Presence of a signed informed consent in which the parent(s)/legally representative(s) have given written informed consent after receiving oral and written information (signature from one parent in case of an orphan, or single-parent family). 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: Any of the following criteria will exclude a volunteer from participation, at start of the study: • Children elegible for the Hepatitis B vaccination • Previous Prevenar and DTaP-IPV-Hib vaccination • Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like cytostatics and prednisolons, that might interfere with the results of the study within 3 months • Any known primary or secondary immunodeficiency • Communication problems interfering in the study realization • Use of blood or bloodproducts • Bleeding disorders • Premature birth (38.5 oC) the vaccination will be postponed • In case a child is having fever (>38.5 oC) within one day before blood sampling which can interfere with the cellular immune responses at that time, another appointment for blood sampling will be made Elimination criteria • Use of blood or bloodproducts • Long-term use of immunosuppressent medication, like cytostatics and prednisolons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessing the optimal PCV vaccination schedule: To assess the effect of the use of pneumococcal vaccination schedules with alternative timing and reduction of the number of vaccination doses on the serological response directed against the different serotypes of pneumococci. This information will be used to investigate whether a different timing or reduction of the vaccination schedule will induce antibody responses that are equal to or better than those obtained by the currently used vaccination schedule. The primairy endpoint for this study will be the antibody titer measured at 12 months, 1 month post-booster.;Secondary Objective: Kinetics of the antibody titer: To assess the kinetics of the pneumococcal antibody titers, in particular in the interval between the last vaccination dose of the primairy series and the booster vaccination at 11 months. This period coincides with the peak incidence of pneumococcal invasive disease. Interference of vaccination with PCV on other vaccinations: To investigate the possible influence of the pneumococcal vaccination on the serological responses of the other vaccine components of the NIP which are administered simultaneously in the other limb (DTaP-IPV-Hib).;Primary end point(s): The primairy endpoint of this study will be the antibody titers against the 13 serotypes of S. pneumoniae measured at 12 months, 1 month post-booster. | — |
Countries
Netherlands
Outcome results
None listed