HealthyNCT00508950
Study Evaluating Serum Collected From Healthy Adults For Development of Pneumococcal Opsonophagocytic Assay
A study testing Large volume blood draw in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The study will identify healthy adults who have been vaccinated against pneumococcus, and collect blood for the purpose of developing laboratory assays. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Large volume blood draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jun 2016
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults 18-70 years of age
- Must have received 23vPS pneumococcal vaccine
Who cannot join
- Bleeding diathesis
- Pregnancy
- Chronic disease which could be worsened by donating blood
- Receipt of blood, blood products or immune globulin within six months
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services Inc.
Secaucus, New Jersey, 07094
About this study
Official title: Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Pneumococcal Opsonophagocytic Assay Development.
The study will identify healthy adults who have been vaccinated against pneumococcus, and collect blood for the purpose of developing laboratory assays.
Read the detailed description
Collect serum with antibody levels capable of killing pneumococcal bacteria from healthy prevaccinated adults to develop OPA assays for the 13 serotypes in 13-valent pneumococcal conjugate vaccine.
- Conditions
- Healthy
- Being tested
- Large volume blood draw
- Keywords
- Vaccines, Pneumococcal Conjugate Vaccine, Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large volume blood drawProcedure or surgery
Large volume blood draw
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Other | All subjects Receives: Procedure: Large volume blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify potential serum donors and obtain unit volumes of blood from these donors for use in pneumococcal opsonophagocytic assay development.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Enrolment
- 152 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
- NCT00508950
- Sponsor's protocol ID
- 6115A1-1000
- Other IDs
- B1851075
- Status last verified
- Aug 2016
- First submitted
- 27 Jul 2007
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Pneumococcal Opsonophagocytic Assay Development.
- ClinicalTrials.gov ID
- NCT00508950
- Acronym / sponsor ID
- 6115A1-1000
- Conditions
- Healthy
- Keywords
- Vaccines, Pneumococcal Conjugate Vaccine, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jul 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.
The study will identify healthy adults who have been vaccinated against pneumococcus, and collect blood for the purpose of developing laboratory assays.
Detailed description
Collect serum with antibody levels capable of killing pneumococcal bacteria from healthy prevaccinated adults to develop OPA assays for the 13 serotypes in 13-valent pneumococcal conjugate vaccine.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Procedure: Large volume blood drawAll subjects |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults 18-70 years of age
- Must have received 23vPS pneumococcal vaccine
Key exclusion criteria (4 listed)
- Bleeding diathesis
- Pregnancy
- Chronic disease which could be worsened by donating blood
- Receipt of blood, blood products or immune globulin within six months
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 |
|---|---|---|
| Large volume blood drawLarge volume blood draw | Procedure or surgery | All subjects |
Primary outcome
To identify potential serum donors and obtain unit volumes of blood from these donors for use in pneumococcal opsonophagocytic assay development.
Time frame: 8 years
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 17 Aug 2016.
- 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?
A study testing Large volume blood draw in people with Healthy, run by Pfizer at 1 site in United States.
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 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 17 Aug 2016. 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 United States. 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.
What does the primary outcome measure?
To identify potential serum donors and obtain unit volumes of blood from these donors for use in pneumococcal opsonophagocytic assay development. (time frame: 8 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 17 Aug 2016.