Meningitis, MeningococcalPhase 1/2NCT00780806
Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults
A Phase 1/2 study testing meningococcal B rLP2086 vaccine candidate and Blood draw in people with Meningitis, Meningococcal, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in Australia.
Trial summary
The purpose of this study is to evaluate the safety of an investigational meningococcal B rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in assay development. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- meningococcal B rLP2086 vaccine candidate and Blood draw
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesAustralia
- Study dates
- Oct 2008to May 2010
- Phase
- Phase 1/2
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subject between the ages of >=18 and <=40 years
- Negative urine pregnancy test for all female subjects of childbearing potential prior to test article administration and at the completion of the study.
- All female or male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control during for the duration of the study and for 30 days after early discontinuation. 4. Hemoglobin levels >=12.0 and <=16.5 g/dL for female subjects and >=13.0 and <=18.5 g/dL for male subjects.
- Blood pressure: Systolic blood pressure >90 and <160 mm Hg; Diastolic blood pressure >60 and <95 mm Hg.
- Body weight >=45 and <=120 kg.
- Able to be contacted by telephone during the study period.
Who cannot join
- Pregnancy or breastfeeding women
- Prior vaccination with a serogroup B meningococcal vaccine.
- A previous anaphylactic or severe vaccine-associated adverse reaction.
- A known hypersensitivity to any study vaccine components.
- A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids (excluding topical, inhalation and intra-articular corticosteroids).
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
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- Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
- Receipt of an inactivated vaccine within 14 days before study vaccinations and live attenuated vaccine within 28 days before study vaccination. This will apply throughout the study until the last vaccination.
- Any clinically significant chronic disease that, in the investigator's judgment may be worsened by blood draw.
- Received any investigational drug, vaccine or device within the 30-day period before study visit 1 and during the conduct of the study.
- History of culture-proven invasive disease caused by N meningitidis or N gonorrhoea.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Pfizer Investigational Site
Herston, QLD 4006
Pfizer Investigational Site
North Adelaide, SA 5006
Pfizer Investigational Site
Subiaco, WA 6008
About this study
Official title: An Open-Label Safety And Blood Collection Study In Mnb Rlp2086 Vaccinated Healthy Adult Volunteers For Immunological Assay Development
The purpose of this study is to evaluate the safety of an investigational meningococcal B rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in assay development.
- Conditions
- Meningitis, Meningococcal
- Being tested
- meningococcal B rLP2086 vaccine candidate, Blood draw
- Keywords
- MnB, rLP2086, blood collection, vaccination
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meningococcal B rLP2086 vaccine candidateBiological
vaccine, 0.5 mL, 3 doses, 0 - 2 - 6 to 9 months
Blood drawProcedure or surgery
Blood draw
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Immunization with one dose of MnB rLP2086 vaccine at 0, 1 and 6 months Receives: Biological: meningococcal B rLP2086 vaccine candidate; Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of 3 doses of MnB rLP2086 vaccine candidate assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccination; evaluation of occurrence of AE and SAE during the duration of study
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 1/2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of 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
- NCT00780806
- Sponsor's protocol ID
- 6108A1-1003
- Other IDs
- B1971003
- Status last verified
- Aug 2011
- First submitted
- 24 Oct 2008
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
PubMed 35164991Marshall HS, Richmond PC, Nissen MD, Wouters A, Baber J, Jiang Q, Anderson AS, Jones TR, Harris SL, Jansen KU, Perez JL. A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults. Vaccine. 2013 Mar 15;31(12):1569-75. doi: 10.1016/j.vaccine.2013.01.021. Epub 2013 Jan 24.
PubMed 23352429
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Safety And Blood Collection Study In Mnb Rlp2086 Vaccinated Healthy Adult Volunteers For Immunological Assay Development
- ClinicalTrials.gov ID
- NCT00780806
- Acronym / sponsor ID
- 6108A1-1003
- Conditions
- Meningitis, Meningococcal
- Keywords
- MnB, rLP2086, blood collection, vaccination
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Oct 2008 (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 purpose of this study is to evaluate the safety of an investigational meningococcal B rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in assay development.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: meningococcal B rLP2086 vaccine candidate, Procedure: Blood drawImmunization with one dose of MnB rLP2086 vaccine at 0, 1 and 6 months |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or female subject between the ages of >=18 and <=40 years
- Negative urine pregnancy test for all female subjects of childbearing potential prior to test article administration and at the completion of the study.
- All female or male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control during for the duration of the study and for 30 days after early discontinuation. 4. Hemoglobin levels >=12.0 and <=16.5 g/dL for female subjects and >=13.0 and <=18.5 g/dL for male subjects.
- Blood pressure: Systolic blood pressure >90 and <160 mm Hg; Diastolic blood pressure >60 and <95 mm Hg.
- Body weight >=45 and <=120 kg.
Key exclusion criteria (11 listed)
- Pregnancy or breastfeeding women
- Prior vaccination with a serogroup B meningococcal vaccine.
- A previous anaphylactic or severe vaccine-associated adverse reaction.
- A known hypersensitivity to any study vaccine components.
- A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids (excluding topical, inhalation and intra-articular corticosteroids).
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 |
|---|---|---|
| meningococcal B rLP2086 vaccine candidatevaccine, 0.5 mL, 3 doses, 0 - 2 - 6 to 9 months | Biological | 1 |
| Blood drawBlood draw | Procedure or surgery | 1 |
Primary outcome
Safety of 3 doses of MnB rLP2086 vaccine candidate assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccination; evaluation of occurrence of AE and SAE during the duration of study
Time frame: Up to 2 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 23 Aug 2011.
- Derived from this study: PubMed 35164991Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
- Derived from this study: PubMed 23352429Marshall HS, Richmond PC, Nissen MD, Wouters A, Baber J, Jiang Q, Anderson AS, Jones TR, Harris SL, Jansen KU, Perez JL. A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults. Vaccine. 2013 Mar 15;31(12):1569-75. doi: 10.1016/j.vaccine.2013.01.021. Epub 2013 Jan 24.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing meningococcal B rLP2086 vaccine candidate and Blood draw 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 6 inclusion and 11 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 23 Aug 2011. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety of 3 doses of MnB rLP2086 vaccine candidate assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccination; evaluation of occurrence of AE and SAE during the duration of study (time frame: Up to 2 years). 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 NCT00780806, which also lists 2 linked publications.
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 23 Aug 2011.