Recurrent Upper and Lower Respiratory Tract Infections (RTIs)Phase 4NCT00161122
Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)
A Phase 4 study testing trivalent inactivated influenza vaccine and combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine in people with Recurrent Upper and Lower Respiratory Tract Infections (RTIs), run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 months
- Conditions the study is for
- Recurrent Upper and Lower Respiratory Tract Infections (RTIs)
- What is being tested?
- trivalent inactivated influenza vaccine and combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 660 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2003to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 months
- All sexes
- Child
Who may be able to join
- Age between 18-72 months
- A history of two or more episodes of general practitioner attended RTIs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Utrecht, 3508 GA
About this study
Official title: 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
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.
- Being tested
- trivalent inactivated influenza vaccine, combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trivalent inactivated influenza vaccineBiological
combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
number of febrile RTI-episodes
Secondary outcomes (1)
severity and length of febrile RTI-episodes as well as medical consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2003
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Upper and Lower Respiratory Tract Infections (RTIs)Studies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 660 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Investigators
- Eelko Hak, PhD, Principal investigator, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161122
- Sponsor's protocol ID
- Primakid 1
- Status last verified
- Jul 2005
- First submitted
- 8 Sep 2005
- Last updated
- 18 Feb 2008
- Results posted
- No
Publications
Schonbeck Y, Sanders EA, Hoes AW, Schilder AG, Verheij TJ, Hak E. Rationale and design of the prevention of respiratory infections and management in children (PRIMAKid) study: a randomized controlled trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in pre-school children with recurrent respiratory tract infections. Vaccine. 2005 Sep 30;23(41):4906-14. doi: 10.1016/j.vaccine.2005.05.021.
PubMed 16005552
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00161122
- Acronym / sponsor ID
- Primakid 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Study start
- Sep 2003
- Study completion
- Jun 2006
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 72 months
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age between 18-72 months
- A history of two or more episodes of general practitioner attended RTIs
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trivalent inactivated influenza vaccine | Biological | – |
| combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine | Biological | – |
Primary outcome
number of febrile RTI-episodes
1 secondary outcome
severity and length of febrile RTI-episodes as well as medical consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2008.
- Background: PubMed 16005552Schonbeck Y, Sanders EA, Hoes AW, Schilder AG, Verheij TJ, Hak E. Rationale and design of the prevention of respiratory infections and management in children (PRIMAKid) study: a randomized controlled trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in pre-school children with recurrent respiratory tract infections. Vaccine. 2005 Sep 30;23(41):4906-14. doi: 10.1016/j.vaccine.2005.05.021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eelko Hak, PhD principal investigator
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing trivalent inactivated influenza vaccine and combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine in people with Recurrent Upper and Lower Respiratory Tract Infections (RTIs), run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of febrile RTI-episodes. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00161122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2008.