HealthyPhase 1NCT00387569
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers
A Phase 1 study testing MnB vaccine rLP8026 in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Australia.
Trial summary
A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it. Read more about this study
- Who is it for?
- Ages 18 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MnB vaccine rLP8026
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2006to Mar 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 18- to 36-months
- Healthy male or female subjects
Who cannot join
- Prior vaccination with a serogroup B meningococcal vaccine
- Prior history of any invasive meningococcal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Observer-Blinded, Parallel-Group, Active-Control, Phase 1/2 Trial of the Safety, Immunogenicity, and Tolerability of 20 µg, 60 µg, and 200 µg of Meningococcal Group B rLP2086 Vaccine in Healthy Adolescents Aged 10 to 12 Years
A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.
- Conditions
- Healthy
- Being tested
- MnB vaccine rLP8026
- Keywords
- Toddlers, Vaccine, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MnB vaccine rLP8026Biological
MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
MnB vaccine rLP8026Biological
MnB vaccine at 60ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
MnB vaccine rLP8026Biological
MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Experimental (20ug); Active Comparator/Placebo Receives: Biological: MnB vaccine rLP8026 |
| Cohort 2 | Experimental | Experimental (60ug); Active Comparator/Placebo Receives: Biological: MnB vaccine rLP8026 |
| Cohort 3 | Experimental | Experimental (200ug); Active Comparator/Placebo Receives: Biological: MnB vaccine rLP8026 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months
Measured: Vaccinations at 0,1,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionMar 2008
- Study completionMar 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
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
- NCT00387569
- Sponsor's protocol ID
- 6108A1-502
- Status last verified
- May 2008
- First submitted
- 11 Oct 2006
- Last updated
- 8 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-Blinded, Parallel-Group, Active-Control, Phase 1/2 Trial of the Safety, Immunogenicity, and Tolerability of 20 µg, 60 µg, and 200 µg of Meningococcal Group B rLP2086 Vaccine in Healthy Adolescents Aged 10 to 12 Years
- ClinicalTrials.gov ID
- NCT00387569
- Acronym / sponsor ID
- 6108A1-502
- Conditions
- Healthy
- Keywords
- Toddlers, Vaccine, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 13 Oct 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.
A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: MnB vaccine rLP8026Experimental (20ug); Active Comparator/Placebo |
| Cohort 2 | Experimental | Biological: MnB vaccine rLP8026Experimental (60ug); Active Comparator/Placebo |
| Cohort 3 | Experimental | Biological: MnB vaccine rLP8026Experimental (200ug); Active Comparator/Placebo |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged 18- to 36-months
- Healthy male or female subjects
Key exclusion criteria (2 listed)
- Prior vaccination with a serogroup B 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 vaccine rLP8026MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively) | Biological | Cohort 1 |
| MnB vaccine rLP8026MnB vaccine at 60ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively) | Biological | Cohort 2 |
| MnB vaccine rLP8026MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively) | Biological | Cohort 3 |
Primary outcome
Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months
Time frame: Vaccinations at 0,1,6 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 8 May 2008.
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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
1 site 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 vaccine rLP8026 in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site 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 2 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 8 May 2008. 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 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 and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months (time frame: Vaccinations at 0,1,6 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 8 May 2008.