Immunity and immunological memory after pneumococcal vaccination in childre
- Conditions
- Immunity and immune memory after pneumococcal vaccination against S. pneumoniae serotypes present in either Synflorix or Prevenar-13Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2011-002103-15-NL
- Lead Sponsor
- RIVM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•The children have to be of normal health (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 (=38.5 °C) or cold are seen as children with normal health)
•The parents/legally representatives 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 (the parents/legally representatives have given written informed consent after receiving oral and written information)
•Group 1: The children are 2 months old (± 2 weeks), have not received any vaccinations and will receive all vaccinations (DTaP-IPV-Hib-HepB and PCV13) by the study team
•Group 2: The children are 4-6 months old and have received three DTaP-IPV-Hib-HepB and PCV10 vaccinations according to the 3+1 schedule of the Dutch NIP*.
*The Dutch NIP 3+1 schedule: All children born as of August 1st 2011 will receive Synflorix (PCV10) and DTaP-IPV-Hib-HepB vaccinations, at the age of 2, 3 4 and 11 months of age.
Are the trial subjects under 18? yes
Number of subjects for this age range: 132
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
•Group 1: Previous vaccinations with PCV7 or PCV10
•Group 2: Previous vaccinations with PCV7 of PCV13
•Vaccinations using a schedule that differs from the Dutch 3+1 schedule
•Presence of a serious disease that requires medical care that can interfere with the results of the study
•Known or expected allergy/hypersensitivity against one of the vaccine ingredients
(anamnestic, be alert if the child has had medical complaints after previous pneumococcal vaccinations)
•Known or suspected immunological disorder
•Previously administration of plasma products (including immunoglobulin), within three months of study enrolment
•Presence of bleeding disorders
•Communication problems that interfere with the trial
•Prematurity (<37 weeks after gestation)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To compare immunogenicity (humoral) induced by PCV10 and PCV13 at 5, 8, 11 and 12 months of a complete vaccination series (3+1, the current NIP schedule) <br><br>To investigate the possible influence of the pneumococcal vaccination on the serological responses of other vaccine components of the NIP which are administered simultaneously in the other limb (DTaP-Hib)<br>;Main Objective: To compare immunogenicity (humoral and cellular) induced by PCV10 and PCV13 after the booster dose of a complete vaccination series (3+1, the current NIP schedule) ;Primary end point(s): Pneumococcal serotypes<br>•Cellular immune response (Plasma B cells and memory B cells) immediately before and 7-9 days after the booster at 11-months of age<br>•Humoral immune response (antibody concentrations and geometric mean concentrations (GMT)) at 12 months of age;Timepoint(s) of evaluation of this end point: Cellular: at 11 months and 7-9 days after 11 months vaccination<br>Humoral: at 12 months
- Secondary Outcome Measures
Name Time Method