HealthyPhase 1NCT00518492
Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
A Phase 1 study testing Blood Sampling in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in Australia.
Trial summary
Upon completion of participation in the 6108A1-500 study, subjects will be asked to consent for this duration of immunity study to provide up to two additional blood samples. SBA \& IgG testing will be done on these samples taken at 6 \& 12 months. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blood Sampling
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 3 sitesAustralia
- Study dates
- Aug 2007to Apr 2008
- Phase
- Phase 1
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completed study 6108A1-500 (three doses administered and visit 9 completed).
Who cannot join
- Bleeding diathesis or condition associated with prolonged bleeding time.
- Any clinically significant chronic disease that, in the investigators judgment may be worsened by blood draw.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Study site
Herson, Queensland, 4006
Study site
North Adealaide, South Australia, 5006
Study site
Perth, Western Australia, 6840
About this study
Official title: Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
Upon completion of participation in the 6108A1-500 study, subjects will be asked to consent for this duration of immunity study to provide up to two additional blood samples. SBA \& IgG testing will be done on these samples taken at 6 \& 12 months. The sites participating in this duration of immunity study are the same sites participating in the 6108A1-500 study.
- Conditions
- Healthy
- Being tested
- Blood Sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SamplingProcedure or surgery
Blood draws at 6 and 12 months following end of 6108A1-500 trial.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Includes subjects from a trial involving experimental vaccine and an active comparator vaccine. Comparator is Twinrix (not a MnB vaccine) and thus is comparator for safety but not immunogencity Receives: Procedure: Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity at 6 and 12 months post 6108A1-500 study.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2008
- Study completionApr 2008
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.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 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 PfizerTrial Manager, Principal investigator, For Australia: medinfo@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518492
- Sponsor's protocol ID
- 6108A1-1002
- Status last verified
- Sep 2009
- First submitted
- 16 Aug 2007
- Last updated
- 16 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
- ClinicalTrials.gov ID
- NCT00518492
- Acronym / sponsor ID
- 6108A1-1002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Aug 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.
Upon completion of participation in the 6108A1-500 study, subjects will be asked to consent for this duration of immunity study to provide up to two additional blood samples. SBA \& IgG testing will be done on these samples taken at 6 \& 12 months. The sites participating in this duration of immunity study are the same sites participating in the 6108A1-500 study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Blood SamplingIncludes subjects from a trial involving experimental vaccine and an active comparator vaccine. Comparator is Twinrix (not a MnB vaccine) and thus is comparator for safety but not immunogencity |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Completed study 6108A1-500 (three doses administered and visit 9 completed).
Key exclusion criteria (2 listed)
- Bleeding diathesis or condition associated with prolonged bleeding time.
- Any clinically significant chronic disease that, in the investigators judgment may be worsened by blood draw.
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 |
|---|---|---|
| Blood SamplingBlood draws at 6 and 12 months following end of 6108A1-500 trial. | Procedure or surgery | Arm 1 |
Primary outcome
Immunogenicity at 6 and 12 months post 6108A1-500 study.
Time frame: 6 and 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 16 Sep 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
Trial Manager principal investigator
For Australia: medinfo@wyeth.com
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blood Sampling in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in Australia.
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 2 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 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Immunogenicity at 6 and 12 months post 6108A1-500 study. (time frame: 6 and 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 16 Sep 2009.