Vaccines, Pneumococcal Conjugate VaccineNCT00683410
Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)
An observational study of Vaccines, Pneumococcal Conjugate Vaccine, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Philippines.
Trial summary
To collect post-marketing information on the safety of Prevenar in Filipino patients Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccines, Pneumococcal Conjugate Vaccine
- What is being tested?
- Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)
- Type of treatment
- Vaccines
- How many people
- 3,366 participants
- Where
- 1 sitePhilippines
- Study dates
- Apr 2007to Oct 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary Care
Who may be able to join
- All patients from the study center who received or will receive at least one dose of Prevenar according to the approved product indication.
Who cannot join
- Previously discontinued Prevenar therapy due to safety concerns.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Pneumococcal Conjugate Vaccine, 7-valent (Prevenar) 0.5 mL by Intramuscular Injection
To collect post-marketing information on the safety of Prevenar in Filipino patients
- Conditions
- Vaccines, Pneumococcal Conjugate Vaccine
- Being tested
- Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)Biological
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Spontaneous Adverse Events
Measured: 30 days post injection up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startApr 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vaccines, Pneumococcal Conjugate VaccineStudies 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
- 3,366 participants (actual)
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
- NCT00683410
- Sponsor's protocol ID
- 0887X-102339
- Status last verified
- Oct 2010
- First submitted
- 21 May 2008
- Last updated
- 16 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Pneumococcal Conjugate Vaccine, 7-valent (Prevenar) 0.5 mL by Intramuscular Injection
- ClinicalTrials.gov ID
- NCT00683410
- Acronym / sponsor ID
- 0887X-102339
- Conditions
- Vaccines, Pneumococcal Conjugate Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,366 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Posted 16 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To collect post-marketing information on the safety of Prevenar in Filipino patients
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary Care
Key inclusion criteria (1 listed)
- All patients from the study center who received or will receive at least one dose of Prevenar according to the approved product indication.
Key exclusion criteria (1 listed)
- Previously discontinued Prevenar therapy due to safety concerns.
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 Conjugate Vaccine, 7-valent (Prevenar) | Biological | 1 |
Primary outcome
Number of Participants With Spontaneous Adverse Events
Time frame: 30 days post injection up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 Vaccines, Pneumococcal Conjugate Vaccine, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Philippines.
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 1 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 16 Nov 2010. 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 Philippines. 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?
Yes. Results are posted in the registry (first posted 16 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Spontaneous Adverse Events (time frame: 30 days post injection up to 3 years). It is what the study was designed to measure, not a finding.
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 16 Nov 2010.