Prevention of Respiratory Infections and MAnagement among Children
| ISRCTN | ISRCTN84713819 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84713819 |
| Protocol serial number | NTR223 |
| Sponsor | The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 15/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A.G.S.C. Jansen
Scientific
Scientific
University Medical Center Utrecht
Julius Center for Health Sciences and Primary Care
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 253 8640 |
|---|---|
| A.G.S.C.Jansen@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo-controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effectiveness and costs of combined influenza and pneumococcal vaccination in pre-school children with recurrent respiratory tract infections (RTI): a general practice-based randomised controlled trial |
| Study acronym | PRIMAKid |
| Study objectives | Combined pneumococcal vaccination with influenza vaccination reduces the occurrence of respiratory tract infections (RTI) in children with recurrent RTI. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Respiratory tract infection (RTI) |
| 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. Combined IV twice and placebo vaccine (saline fluid) twice) with a repeated IV after 1 year 3. Control intervention: combined Hepatitis B vaccine twice and placebo vaccine (saline fluid) twice with one repeated Hepatitis B vaccination after 1 year |
| Intervention type | Other |
| Primary outcome measure(s) |
Number of febrile RTI episodes |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 18 Months |
| Upper age limit | 72 Months |
| Sex | All |
| Target sample size at registration | 660 |
| Key inclusion criteria | 1. Aged between 18 - 72 months 2. A history of two or more episodes of general practitioner attended RTIs |
| Key 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 |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 30/06/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
