Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
15/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.zonmw.nl

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes