Meningitis, MeningococcalPhase 1NCT00297687
Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
A Phase 1 study testing MnB rLP2086 in people with Meningitis, Meningococcal, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in Australia.
Trial summary
To determine the safety \& immunogenicity of a potential vaccine against meningococcal B disease Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- MnB rLP2086
- How many people
- 108 participants
- Where
- 3 sitesAustralia
- Study dates
- Mar 2006to Mar 2007
- 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
- Healthy 18-25 year olds
Who cannot join
- Prior history of vaccination with any meningococcal vaccine
- Prior history of any invasive meningococcal disease
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: A Randomized, Placebo-Controlled, Double Blind, Phase 1 Trial of the Safety, Immunogenicity, and Tolerability of Ascending Doses of Meningococcal Group B rLP2086 Vaccine in Healthy Adults
To determine the safety \& immunogenicity of a potential vaccine against meningococcal B disease
- Conditions
- Meningitis, Meningococcal
- Being tested
- MnB rLP2086
- Keywords
- Vaccines, Healthy Adults, Health, Adult, Meningococcal Vaccines
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MnB rLP2086Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Local & systemic safety throughout the trial
Secondary outcomes (1)
Evidence of an immune response 1 month after dose 2 & 1 month after dose 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startMar 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningitis, MeningococcalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 108 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 PfizerTrial Manager, Principal investigator, For Australia, medinfo@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297687
- Sponsor's protocol ID
- 6108A1-500
- Status last verified
- Dec 2007
- First submitted
- 24 Feb 2006
- Last updated
- 5 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double Blind, Phase 1 Trial of the Safety, Immunogenicity, and Tolerability of Ascending Doses of Meningococcal Group B rLP2086 Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT00297687
- Acronym / sponsor ID
- 6108A1-500
- Conditions
- Meningitis, Meningococcal
- Keywords
- Vaccines, Healthy Adults, Health, Adult, Meningococcal Vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 28 Feb 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 safety \& immunogenicity of a potential vaccine against meningococcal B disease
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy 18-25 year olds
Key exclusion criteria (2 listed)
- Prior history of vaccination with any meningococcal vaccine
- Prior history of any invasive meningococcal disease
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 |
|---|---|---|
| MnB rLP2086 | Biological | – |
Primary outcome
Local & systemic safety throughout the trial
1 secondary outcome
Evidence of an immune response 1 month after dose 2 & 1 month after dose 3
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 5 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
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 MnB rLP2086 in people with Meningitis, Meningococcal, 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 5 Dec 2007. 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?
Local & systemic safety throughout the trial. 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 5 Dec 2007.