Invasive Pneumococcal DiseaseNCT00227188
Study Evaluating Prevenar in the Prevention of Invasive Pneumococcal Disease (IPD) in the Paediatric Population in Spain.
An observational study of Invasive Pneumococcal Disease, run by Pfizer at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the postlicensure effectiveness of Prevnar in the prevention of IPD in the Spanish paediatric population (children younger than 5 years) Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Invasive Pneumococcal Disease
- What is being tested?
- Pneumococcal 7-valent conjugate vaccine Prevnar
- Type of treatment
- Vaccines
- How many people
- 408 participants
- Where
- 1 siteSpain
- Study dates
- May 2003to Dec 2005
- Phase
- Observational
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: All public and private hospitals with a pediatric department belonging to one of the two autonomous communities.
Who may be able to join
- All children from 0 up to 5 years attending to the hospital's emergency department will be evaluated for IPD.
- Diagnosis of IPD will be based on positive pneumococcal isolation in any sterile location, such us blood or spinal fluid.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Prevnar in the Prevention on IPD in the Paediatric Population in Spain
The aim of this study is to evaluate the postlicensure effectiveness of Prevnar in the prevention of IPD in the Spanish paediatric population (children younger than 5 years)
- Conditions
- Invasive Pneumococcal Disease
- Being tested
- Pneumococcal 7-valent conjugate vaccine Prevnar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal 7-valent conjugate vaccine PrevnarDrug
Also called PREVNAR
| Study group | Role | What they receive |
|---|---|---|
| 1 | Children from 0-5 years of age evaluated for IPD Receives: Drug: Pneumococcal 7-valent conjugate vaccine Prevnar |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Pneumococcal DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227188
- Sponsor's protocol ID
- 0887-101317
- Status last verified
- Nov 2012
- First submitted
- 13 Sep 2005
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prevnar in the Prevention on IPD in the Paediatric Population in Spain
- ClinicalTrials.gov ID
- NCT00227188
- Acronym / sponsor ID
- 0887-101317
- Conditions
- Invasive Pneumococcal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 27 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 aim of this study is to evaluate the postlicensure effectiveness of Prevnar in the prevention of IPD in the Spanish paediatric population (children younger than 5 years)
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Pneumococcal 7-valent conjugate vaccine PrevnarChildren from 0-5 years of age evaluated for IPD |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All public and private hospitals with a pediatric department belonging to one of the two autonomous communities.
Key inclusion criteria (2 listed)
- All children from 0 up to 5 years attending to the hospital's emergency department will be evaluated for IPD.
- Diagnosis of IPD will be based on positive pneumococcal isolation in any sterile location, such us blood or spinal fluid.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Pneumococcal 7-valent conjugate vaccine PrevnarAlso: PREVNAR | Drug | 1 |
Primary outcome
Not reported in the source record.
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 29 Nov 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Pneumococcal Disease, run by Pfizer at 1 site in Spain.
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 0 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 29 Nov 2012. 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 Spain. 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.
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.
Where can I read the original study information?
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 29 Nov 2012.