Immunogenicity of alternative and reduced immunization schedules using the thirteen-valent polysaccharide conjugate vaccine against infection with Streptococcus pneumoniae

Phase 4

Completed

Conditions: pneumococcal infection
Streptococcus Pneumoniae
10004018

Registration Number: NL-OMON35410

Lead Sponsor: RIVM

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 400

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).

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
• Vaccination with any vaccine other than those used in the RVP within a month before the blood sampling
• Bleeding disorders
• Premature birth (<37 weeks);Delay criteria
• In case of fever (>38.5 oC) the vaccination will be postponed
• In case a child is having fever (>38 oC) within 2 days before blood sampling which can interfere with the cellular immune responses at that time, another appointment for blood sampling will be made

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Assessing the optimal PCV vaccination schedule: To assess the effect of the use<br /><br>of pneumococcal vaccination schedules with alternative timing and reduction of<br /><br>the number of vaccination doses on the serological response directed against<br /><br>the different serotypes of pneumococci. This information will be used to<br /><br>investigate whether a different timing or reduction of the vaccination schedule<br /><br>will induce antibody responses that are equal to or better than those obtained<br /><br>by the currently used vaccination schedule.<br /><br>For each vaccine group, differences in serotype specific antibody<br /><br>concentrations between different schedules will be analysed. The primary<br /><br>endpoints are the antibody concentrations against pneumococcal polysaccharides<br /><br>for each serotype at 12 months in the different study arms. GMCs and the degree<br /><br>of protection (the proportion with concentration > 0.35 µg/ml) will be<br /><br>determined.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Kinetics of the antibody titer: To assess the kinetics of the pneumococcal<br /><br>antibody titers, in particular in the interval between the last vaccination<br /><br>dose of the primairy series and the booster vaccination at 11 months. This<br /><br>period coincides with the peak incidence of pneumococcal invasive disease. The<br /><br>antibody concentrations of the longitudinal samples of each child will be used<br /><br>to assess the kinetics.<br /><br><br /><br>Interference of vaccination with PCV on other vaccinations: To investigate the<br /><br>possible influence of the pneumococcal vaccination on the serological responses<br /><br>of the other vaccine components of the NIP which are administered<br /><br>simultaneously in the other limb (DTaP-IPV-Hib). For this the antibody<br /><br>concentrations (GMCs) directed to the other vaccine components of the NIP will<br /><br>be determined.</p><br>