Vaccines, PneumococcalPhase 4NCT00580684
Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children
A Phase 4 study testing pneumococcus conjugate vaccine 7 valent to reduce carriage in people with Vaccines, Pneumococcal and Vaccines, Pneumococcal Conjugate Vaccine, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage. Read more about this study
- Who is it for?
- Ages 2 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccines, Pneumococcal, Vaccines, Pneumococcal Conjugate Vaccine
- What is being tested?
- pneumococcus conjugate vaccine 7 valent to reduce carriage
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Aug 2004
- 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 2 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children between
- 2 to 9 years old.
- No history of antibiotic use prior 1 month of enrollment
- No history of invasive pneumococcal disease
Who cannot join
None listed.
About this study
Official title: Long-Term Efficacy of Pneumococcal Conjugate 7-Valent Vaccine Versus Plain Polisaccharide Pneumococcus Vacine in Reducing Pneumococcal Nasopharyngeal Carriage of Children.
To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.
Read the detailed description
This study will require 6 months to be completed (3 months for nasopharyngeal samples collection; 3 months dor analysis). Each child will participate for a 1 day period.
- Being tested
- pneumococcus conjugate vaccine 7 valent to reduce carriage
- Keywords
- pneumococcus conjugated vaccine 7 valent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumococcus conjugate vaccine 7 valent to reduce carriageBiological
plain polisacaride vaccine 23 valent to reduce carriage
| Study group | Role | What they receive |
|---|---|---|
| G1 | Active comparator | G1: prevenar Receives: Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage |
| G2 | Active comparator | G2: pneumo 23 Receives: Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization.
Measured: 12 months
Secondary outcomes (1)
To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startSep 2003
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccines, PneumococcalStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 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
- NCT00580684
- Sponsor's protocol ID
- 0887X-101198
- Status last verified
- Dec 2007
- First submitted
- 21 Dec 2007
- Last updated
- 27 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Efficacy of Pneumococcal Conjugate 7-Valent Vaccine Versus Plain Polisaccharide Pneumococcus Vacine in Reducing Pneumococcal Nasopharyngeal Carriage of Children.
- ClinicalTrials.gov ID
- NCT00580684
- Acronym / sponsor ID
- 0887X-101198
- Keywords
- pneumococcus conjugated vaccine 7 valent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Aug 2004 (actual)
- First posted
- 27 Dec 2007 (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.
To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.
Detailed description
This study will require 6 months to be completed (3 months for nasopharyngeal samples collection; 3 months dor analysis). Each child will participate for a 1 day period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1 | Active comparator | Biological: pneumococcus conjugate vaccine 7 valent to reduce carriageG1: prevenar |
| G2 | Active comparator | Biological: pneumococcus conjugate vaccine 7 valent to reduce carriageG2: pneumo 23 |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children between
- 2 to 9 years old.
- No history of antibiotic use prior 1 month of enrollment
- No history of invasive pneumococcal disease
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 |
|---|---|---|
| pneumococcus conjugate vaccine 7 valent to reduce carriageplain polisacaride vaccine 23 valent to reduce carriage | Biological | G1, G2 |
Primary outcome
To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization.
Time frame: 12 months
1 secondary outcome
To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.
Time frame: 12 months
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 27 Dec 2007.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pneumococcus conjugate vaccine 7 valent to reduce carriage in people with Vaccines, Pneumococcal and Vaccines, Pneumococcal Conjugate Vaccine, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 4 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 27 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. (time frame: 12 months). 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 27 Dec 2007.