Invasive pneumococcal disease, Respiratory tract infection. Added as of 22/05/2007: Change in: nasopharyngeal carriage after reduced doses 7-valent conjugate vaccine, antipneumococcal antibody development, family transmission of pneumococci Infections and Infestations Invasive pneumococcal disease
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 month
Sponsors
University Medical Centre Utrecht (UMCU) (Netherlands)
Eligibility
Sex/Gender
All
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 Added as of 22/05/2007: 7. Comparison of anti-pneumococcal antibody levels after vaccinations at 2, 4 and 24 months, at 2, 4, 11 and 24 months and after primo-vaccination at 24 months of age in subgroups of 80 children of groups I, II and III 8. Comparison of B-memory cells after vaccination at 24 months of age after vaccination schemes of groups I, II and III | — |
Countries
Netherlands
Outcome results
None listed