Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)

Effectiveness and Costs of Combined Influenza and Pneumococcal Vaccination in Pre-School Children With Recurrent Respiratory Tract Infections (RTI): a General Practice-Based Randomized Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161122

Enrollment

660

Registered

2005-09-12

Start date

2003-09-30

Completion date

2006-06-30

Last updated

2008-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Upper and Lower Respiratory Tract Infections (RTIs)

Brief summary

The PRIMAKid trial is a general practice based double-blind randomized placebo-controlled trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in pre-school children with recurrent respiratory tract infections. A target number of 660 children aged 18-72 months with a history of two or more general practitioner attended episodes of RTI, are included. Exclusion criteria are diseases accompanied by a high risk of recurrent RTI and conditions chronically treated with corticosteroids. Over a period of 7 to 22 months follow-up, the number of febrile RTI-episodes as primary outcome is assessed, and as secondary outcomes the severity and length of febrile RTI-episodes, medical visits / interventions, health-related quality of life and productivity loss of parents.

Interventions

BIOLOGICALtrivalent inactivated influenza vaccine

BIOLOGICALcombined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Months to 72 Months

Inclusion criteria

* Age between 18-72 months * A history of two or more episodes of general practitioner attended RTIs

Exclusion criteria

* No intention to move within 12 months to another region * Provision of informed consent * Good mastering of the Dutch language * Absence of chronic diseases such as asthma treated with corticosteroids or high-risk disease (such as palatoschisis, Down syndrome, cystic fibrosis, etc.) * No previous influenza vaccination or pneumococcal vaccination or Hepatitis B vaccination * 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 medical consumption	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026