recurrent upper and lower respiratory tract infections (RTI).
Conditions
Interventions
Study intervention 1:
combined heptavalent pneumococcal conjugate vaccine twice and trivalent inactivated influenza vaccine (IV) twice with one repeated IV after 1 year. (5 doses in total).
2.:
c
Sponsors
The Netherlands Organization for Health Research and Development ZONMW (grant number 2200.0121)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18-72 months; 2. A history of two or more episodes of general practitioner attended RTIs.
Exclusion criteria
Exclusion criteria: 1. No intention to move within 12 months to another region; 2. Provision of informed consent; 3. Good mastering of the Dutch language; 4. Absence of chronic diseases such as asthma treated with corticosteroids or high-risk disease (such as palatoschisis, Down syndrome, cystic fibrosis, etc.); 5. No previous influenza vaccination or pneumococcal vaccination or Hepatitis B vaccination; 6. No hypersensitivity to eggs and/or antibiotics, and/or serious history of serious adverse events through vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of febrile RTI-episodes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity and length of febrile RTI-episodes as well as RTI-associated antibiotic prescriptions, medical visits, clinical laboratory diagnostic procedures, specialist referral and treatment with procedures like ventilatory tube placement or adeno-tonsillectomy, improvement of health-related quality of life, and reduced productivity loss of parents. Follow-up time varies from 7 to 22 months. | — |
Contacts
Public ContactA.G.S.C. Jansen
University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care, P.O. Box 85500
Outcome results
None listed