Contact information
Type
Scientific
Primary contact
Dr A.G.S.C. Jansen
ORCID ID
Contact details
University Medical Center Utrecht
Julius Center for Health Sciences and Primary Care
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 253 8640
A.G.S.C.Jansen@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR223
Study information
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
Acronym
PRIMAKid
Study hypothesis
Combined pneumococcal vaccination with influenza vaccination reduces the occurrence of respiratory tract infections (RTI) in children with recurrent RTI.
Ethics approval
Received from the local medical ethics committee
Study design
Randomised double blind placebo-controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
Number of febrile RTI episodes
Secondary outcome measures
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.
Overall trial start date
01/09/2003
Overall trial end date
30/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged between 18 - 72 months
2. A history of two or more episodes of general practitioner attended RTIs
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
660
Participant 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
Recruitment start date
01/09/2003
Recruitment end date
30/06/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
P.O. Box 93245
Den Haag
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list