Infectious diseases, Streptococcus pneumonia, pneumococcal vaccination
Conditions
Interventions
1. Pneumococcalpolysaccharide conjugate vaccine (13-valent, adsorbed) (Prevenar-13), 0.5 ml via intramuscular injection at 2, 3, 4 and 11 months
2. Pneumococcal polysaccharide conjugate vaccine (adsorbed) (Synflorix), 0.5 ml via intramuscular injection at 2, 3, 4 and 11 months.
Sponsors
National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control (CIb)
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 (<38.5C) or cold are seen as children with normal health); 2. The parents/legally representatives have to be willing and able to allow their child to participate in the trial according to the described procedures; 3. Presence of a signed informed consent (the parents/legally representatives have given written informed consent after receiving oral and written information); 4. PCV13 group: 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; 5. PCV10 group: 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.
Exclusion criteria
Exclusion criteria: 1. PCV13 group: Previous vaccinations with PCV7 or PCV10; 2. PCV10 group: Previous vaccinations with PCV7 or PCV13; 3. PCV10 group: Vaccinations using a schedule that differs from the Dutch 3+1 schedule; 4. Presence of a serious disease that requires medical care that can interfere with the results of the study; 5. Known or expected allergy/hypersensitivity against one of the vaccine ingredients; 6. Known or suspected immunological disorder; 7. Previously administration of plasma products (including immunoglobulin), within three months of study enrolment; 8. Presence of bleeding disorders; 9.Communication problems that interfere with the trial; 10. Prematurity (<37 weeks after gestation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cellular immune response (Plasma B cells and memory B cells) immediately before and 7-9 days after the booster at 11-months of age; 2. Humoral immune response (antibody concentrations and geometric mean concentrations (GMT)) at 12 months of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Opsonophagocytoses immediately before and 7-9 days after the booster at 11-months of age; 2. Avidity at 5, 8, immediately before and 7-9 days after the booster at 11-months and at 12 months of age; 3. Antibody concentrations and geometric mean concentrations (GMT) at 5, 8, immediately before and 7-9 days after the booster at 11-months and at 12 months of age; 4. Kinetics of antibody concentrations and geometric mean concentrations (GMT) over time (at 5, 8, 11 and 12 months of age); 5. DTaP-HIb antibody concentrations and geometric mean concentrations (GMT) at 5, 8, 11 and 12 months of age. | — |
Contacts
Public ContactAlienke Wijmenga-Monsuur
RIVM
Outcome results
None listed