Staphylococcal InfectionsPhase 3NCT00211991
Evaluation of Consistency of StaphVAX Manufacturing Lots
A Phase 3 study testing S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate in people with Staphylococcal Infections, run by Nabi Biopharmaceuticals at 1 site in United States.
Trial summary
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of the consistency of manufacturing of a vaccine. Subjects are randomized to one of three lots of vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jul 2005
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy,
- written informed consent,
- negative serum pregnancy test if appropriate,
- expect to comply with protocol procedures and schedule
Who cannot join
- known HIV,
- immunomodulatory drugs,
- malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
- active infection in the 2 weeks prior to study injection,
- serious S. aureus infection within the last 3 months prior to injection,
- use of investigational drugs, vaccines or devices within the prior 30 days,
- hypersensitivity to components of StaphVAX
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Compare Immunogenicity and Safety Between Three Commercial Lots of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Normal, Healthy, Adult Volunteers
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of the consistency of manufacturing of a vaccine. Subjects are randomized to one of three lots of vaccine. The antibodies in the blood measure the immunogenicity of each lot of vaccine, and typical vaccine safety information is also collected.
- Conditions
- Staphylococcal Infections
- Being tested
- S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S. aureus Type 5 & 8 Capsular Polysaccharide ConjugateBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Type-specific antibody concentrations 6 weeks after vaccine dose.
Secondary outcomes (2)
Antibody concentrations at other time points.
Elicited health events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staphylococcal 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 354 participants
Sponsor and investigators
- Lead sponsor
- Nabi Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- Matt Hohenboken, MD, PhD, Study director, Nabi Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211991
- Sponsor's protocol ID
- Nabi-1369
- Status last verified
- May 2012
- First submitted
- 13 Sep 2005
- Last updated
- 14 May 2012
- Results posted
- No
Publications
Creech CB 2nd, Johnson BG, Alsentzer AR, Hohenboken M, Edwards KM, Talbot TR 3rd. Vaccination as infection control: a pilot study to determine the impact of Staphylococcus aureus vaccination on nasal carriage. Vaccine. 2009 Dec 10;28(1):256-60. doi: 10.1016/j.vaccine.2009.09.088. Epub 2009 Sep 30.
PubMed 19799842
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Compare Immunogenicity and Safety Between Three Commercial Lots of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Normal, Healthy, Adult Volunteers
- ClinicalTrials.gov ID
- NCT00211991
- Acronym / sponsor ID
- Nabi-1369
- Conditions
- Staphylococcal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University
- Study start
- Apr 2005
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 21 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.
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of the consistency of manufacturing of a vaccine. Subjects are randomized to one of three lots of vaccine. The antibodies in the blood measure the immunogenicity of each lot of vaccine, and typical vaccine safety information is also collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy,
- written informed consent,
- negative serum pregnancy test if appropriate,
- expect to comply with protocol procedures and schedule
Key exclusion criteria (7 listed)
- known HIV,
- immunomodulatory drugs,
- malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
- active infection in the 2 weeks prior to study injection,
- serious S. aureus infection within the last 3 months prior to injection,
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 |
|---|---|---|
| S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate | Biological | – |
Primary outcome
Type-specific antibody concentrations 6 weeks after vaccine dose.
2 secondary outcomes
Antibody concentrations at other time points.
Elicited health events.
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 14 May 2012.
- Derived from this study: PubMed 19799842Creech CB 2nd, Johnson BG, Alsentzer AR, Hohenboken M, Edwards KM, Talbot TR 3rd. Vaccination as infection control: a pilot study to determine the impact of Staphylococcus aureus vaccination on nasal carriage. Vaccine. 2009 Dec 10;28(1):256-60. doi: 10.1016/j.vaccine.2009.09.088. Epub 2009 Sep 30.
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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.
Matt Hohenboken, MD, PhD study director
Nabi Biopharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate in people with Staphylococcal Infections, run by Nabi Biopharmaceuticals 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 4 inclusion and 7 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 14 May 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Type-specific antibody concentrations 6 weeks after vaccine dose.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00211991, which also lists 1 linked publication.
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 14 May 2012.