Pneumococcal InfectionsPhase 4NCT00276107
Study Evaluating Prevenar Vaccine in Healthy Infants
A Phase 4 study testing Prevenar in people with Pneumococcal Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age. Read more about this study
- Who is it for?
- Ages 42 to 100 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Prevenar
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Dec 2005
- 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 42 to 100 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male and female children 2 months of age (42 to 100 days) in good health.
- An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study.
- Infants whose parent(s)/guardian(s) will be available for the entire study period.
Who cannot join
- Hypersensitivity to any component of the vaccine, including diphtheria toxoid
- Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy.
- Other exclusions apply.
About this study
Official title: An Open-Label Trial of the Immunogenicity and Safety of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine [Diphteria CRM197 Protein Conjugate]) in Healthy Infants at 2, 4 and 6 Months of Age
To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.
- Conditions
- Pneumococcal Infections
- Being tested
- Prevenar
- Keywords
- Vaccine, Healthy Infants
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age
Secondary outcomes (1)
To determine the antibody responses to the seven pneumococcal vaccine serotypes after second dose and to determine the safety of Prevenar in infants immunized at 2, 4 and 6 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startDec 2004
- Study completionDec 2005
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
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
- NCT00276107
- Sponsor's protocol ID
- 0887X-101446
- Status last verified
- Jul 2009
- First submitted
- 11 Jan 2006
- Last updated
- 29 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Trial of the Immunogenicity and Safety of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine [Diphteria CRM197 Protein Conjugate]) in Healthy Infants at 2, 4 and 6 Months of Age
- ClinicalTrials.gov ID
- NCT00276107
- Acronym / sponsor ID
- 0887X-101446
- Conditions
- Pneumococcal Infections
- Keywords
- Vaccine, Healthy Infants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Dec 2005
- First posted
- 12 Jan 2006 (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 determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 42 to 100 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy male and female children 2 months of age (42 to 100 days) in good health.
- An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study.
- Infants whose parent(s)/guardian(s) will be available for the entire study period.
Key exclusion criteria (4 listed)
- Hypersensitivity to any component of the vaccine, including diphtheria toxoid
- Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy.
- Other exclusions apply.
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 |
|---|---|---|
| Prevenar | Biological | – |
Primary outcome
To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age
1 secondary outcome
To determine the antibody responses to the seven pneumococcal vaccine serotypes after second dose and to determine the safety of Prevenar in infants immunized at 2, 4 and 6 months of age
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 Jul 2009.
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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 Prevenar in people with Pneumococcal Infections, 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 3 inclusion and 4 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 Jul 2009. 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 determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. 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 29 Jul 2009.