Immunogenicity of alternative and reduced immunization schedules using the thirteen-valent polysaccharide conjugate vaccine against infection with Streptococcus pneumoniae.
Completed
- Conditions
- Infectious diseases, vaccine preventable diseases, national immunisation programme, immunogenicity, Streptococcus pneumoniae.Infectieziekten, Rijksvaccinatieprogramma, pneumokokken-vaccinatieschema.
- Registration Number
- NL-OMON26136
- Lead Sponsor
- ational Institute for Public Health and theEnvironment (RIVM), Centre for Infectious Disease Control (CIb).
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
1. 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;
2. The parents have to be willing and able to allow their child to participate in the trial according to the described procedures;
Exclusion Criteria
1. Children elegible for the Hepatitis B vaccination;
2. Previous Prevenar and DTaP-IPV-Hib vaccination;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primairy endpoint of this study will be the antibody concentrations against the 13 serotypes of S. pneumoniae included in the vaccine measured at 12 months, 1 month post-booster vaccination. Serum samples will be analysed for specific IgG by a fluorescent-bead-based multiplex immunoassay (MIA).
- Secondary Outcome Measures
Name Time Method Secondary endpoints are the antibody concentrations at 1 month post-primary, at 8 months and 11 months against the 13 serotypes of S. pneumoniae, and the antibody concentrations against the concomittant vaccines (DTaP-IPV-Hib) to exclude possible interference.