Prevention of Respiratory Infections and MAnagement among Children

ISRCTN ISRCTN84713819
DOI https://doi.org/10.1186/ISRCTN84713819
Secondary identifying numbers NTR223
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

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
Email A.G.S.C.Jansen@umcutrecht.nl

Study information

Study designRandomised double blind placebo-controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffectiveness 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 acronymPRIMAKid
Study objectivesCombined 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) studiedRespiratory tract infection (RTI)
Intervention1. 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 typeOther
Primary outcome measureNumber of febrile RTI episodes
Secondary outcome measuresSeverity 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.
Overall study start date01/09/2003
Completion date30/06/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit18 Months
Upper age limit72 Months
SexBoth
Target number of participants660
Key inclusion criteria1. Aged between 18 - 72 months
2. A history of two or more episodes of general practitioner attended RTIs
Key exclusion criteria1. 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 enrolment01/09/2003
Date of final enrolment30/06/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Research organisation

P.O. Box 93245
Den Haag
2509 AE
Netherlands

Phone +31 (0)70 349 5111
Email info@zonmw.nl
Website http://www.zonmw.nl
ROR logo "ROR" https://ror.org/01yaj9a77

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan