Prevention of invasive pneumococcal disease in healthy infants
Conditions
Interventions
Three groups of each 333 newborns
Group I: Prevnar at age 2 and 4 months
Group II: Prevnar at age 2, 4 and 11 months
Group III: Prevnar at age 24 months.
Sponsors
Prof Dr EAM Sanders
University Medical Center Utrecht
Department of Pediatric Immunology
HP 06.063.0
Lundlaan 6
POBox 85090
3508 AB Utrecht, The Netherlands
Phone 31 30 2504000
Fax 31 30 2505350
email l.sanders@umcutrecht.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1000 healthy newborns (and family members) who will receive childhood vaccinations according to the national vaccination program, starting at 2 months of age.
Exclusion criteria
Exclusion criteria: Exclusion from the national vaccination program because of the presence of a medical condition requiring treatment that can interfere with the results of vaccinations, known of suspected allergy to components of the vaccine, known or suspected immunodeficiency disease other than IgA or IgG-subclass deficiency, previous treatment with plasma or immunoglobulins, previous vaccinations other than hepatitis B vaccinations, coagulations disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pneumococcal nasopharyngeal carriage before 2 months of age, and at 6, 12, 18 and 24 months of age in vaccinated children (groups I and II) and controls (group III), and NP pneumococcal carriage of siblings and parents/caregivers when the baby is 12 and 24 months of age (herd immunity). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Determination of pneumococcal (vaccine and non-vaccine serotypes) colonization of infants in the Netherlands before introduction of Prevnar in the National Vaccination Program (group III); 2. Evaluation of replacing pneumococcal serotypes after Prevnar vaccinations; 3. Influence of Prevnar vaccinations on other colonizing bacterial species like Staphylococcus, H. influenzae, M. catarrhalis and Streptococcus>; 4. Anti pneumococcal antibody levels at 12 and 24 months after 2 doses as compared to 2+1 Prevnar vaccinations; 5. Relation between invasive pneumococcal disease and pneumococcal colonization in the Netherlands; 6. Evaluation of potential reduction of physician-diagnosed acute otitis media and lower respiratory tract infections after pneumococcal conjugate vaccinations. | — |
Contacts
Public ContactE.A.M. Sanders
University Medical Center Utrecht (UMCU), Department of Pediatric Immunology, HP 06.063.0, P.O. Box 85090
Outcome results
None listed