Pneumococcal InfectionsNCT00195390
Study Investigating Administration of Prevenar for Post-Marketing Surveillance
An observational study of Pneumococcal Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in South Korea.
Trial summary
The purpose of this study is to identify the following problems and questions with respect to the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar, during the post-marketing period in Korea, as required by Korea Food and Drug Administration (KFDA) regulations. 1. Read more about this study
- Who is it for?
- Ages 6 weeks to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Prevenar
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2004to Jul 2008
- 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 6 weeks to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Primary care clinic, secondary and tertiary medical centers
Who may be able to join
- Infants and children aged 6 weeks to 9 years, provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the package insert do not apply.
Who cannot join
- Hypersensitivity to latex or to any component of the vaccine, including diphtheria toxoid
- Suffering from a current or recent febrile illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine) Administration for Post-Marketing Surveillance
The purpose of this study is to identify the following problems and questions with respect to the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar, during the post-marketing period in Korea, as required by Korea Food and Drug Administration (KFDA) regulations.
- Adverse reactions (especially serious adverse reactions)
- Incidences of adverse reactions under routine vaccine use
- Factors that may affect the safety of the vaccine
- Conditions
- Pneumococcal Infections
- Being tested
- Prevenar
- Keywords
- Vaccine, heptavalent pneumococcal conjugate vaccine
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevenarBiological
Prevenar 0.5ml/ Vial and PFS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJul 2004
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195390
- Sponsor's protocol ID
- 0887X-101583
- Status last verified
- Sep 2008
- First submitted
- 12 Sep 2005
- Last updated
- 25 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine) Administration for Post-Marketing Surveillance
- ClinicalTrials.gov ID
- NCT00195390
- Acronym / sponsor ID
- 0887X-101583
- Conditions
- Pneumococcal Infections
- Keywords
- Vaccine, heptavalent pneumococcal conjugate vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Jul 2008 (actual)
- First posted
- 19 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 purpose of this study is to identify the following problems and questions with respect to the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar, during the post-marketing period in Korea, as required by Korea Food and Drug Administration (KFDA) regulations.
- Adverse reactions (especially serious adverse reactions)
- Incidences of adverse reactions under routine vaccine use
- Factors that may affect the safety of the vaccine
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 weeks to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Primary care clinic, secondary and tertiary medical centers
Key inclusion criteria (1 listed)
- Infants and children aged 6 weeks to 9 years, provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the package insert do not apply.
Key exclusion criteria (2 listed)
- Hypersensitivity to latex or to any component of the vaccine, including diphtheria toxoid
- Suffering from a current or recent febrile illness.
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 |
|---|---|---|
| PrevenarPrevenar 0.5ml/ Vial and PFS | Biological | – |
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 25 Sep 2008.
Related trials for Pneumococcal Infections
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of 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 Pneumococcal Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in South Korea.
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 1 inclusion and 2 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 25 Sep 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 South Korea. 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 25 Sep 2008.