Meningococcal DiseasePhase 2NCT00297817
Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents
A Phase 2 study testing serogroup B meningococcal vaccine in people with Meningococcal Disease, run by Novartis Vaccines at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease
- What is being tested?
- serogroup B meningococcal vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2006to Apr 2007
- Phase
- Phase 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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy Adolescents between and including 11-18 years of age, who provide written informed consent.
Who cannot join
- Previous or suspected disease caused by N. meningitidis; or previous immunization with a serogroup B meningococcal vaccine; Any acute, chronic or progressive disease.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Atlanta, Georgia, 30322
Study site
Cleveland, Ohio, 44118
Study site
Encinitas, California, 92024
Study site
Galveston, Texas, 77555
Study site
Layton, Utah, 84123
Study site
Salt Lake City, Utah, 84121
Study site
Seattle, Washington, 98101
Study site
St Louis, Missouri, 63110
About this study
Official title: A Phase 2, Single-Blind, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine ± OMV When Administered at an 0-2-6-Month Schedule in Healthy Adolescents 11-18 Years of Age
The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.
- Conditions
- Meningococcal Disease
- Being tested
- serogroup B meningococcal vaccine
- Keywords
- Meningococcal Disease; Meningococcal Meningitis; Vaccine
- Medical subject headings
- Meningococcal Infections, Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serogroup B meningococcal vaccineBiological
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
serogroup B meningococcal vaccineBiological
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
serogroup B meningococcal vaccineBiological
0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: rMenB | Experimental | Not described Receives: Biological: serogroup B meningococcal vaccine |
| Arm 2: rMenB + OMV | Experimental | Not described Receives: Biological: serogroup B meningococcal vaccine |
| Arm 3: Placebo | Placebo comparator | Not described Receives: Biological: serogroup B meningococcal vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents
Measured: 1 month after completion of immunization schedule
Secondary outcomes (1)
Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents
Measured: 6 months after completion of immunization schedule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal DiseaseStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines - Drug Information Services, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297817
- Sponsor's protocol ID
- V72P3
- Status last verified
- Jan 2012
- First submitted
- 27 Feb 2006
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Blind, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine ± OMV When Administered at an 0-2-6-Month Schedule in Healthy Adolescents 11-18 Years of Age
- ClinicalTrials.gov ID
- NCT00297817
- Acronym / sponsor ID
- V72P3
- Conditions
- Meningococcal Disease
- Keywords
- Meningococcal Disease; Meningococcal Meningitis; Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 1 Mar 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.
The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: rMenB | Experimental | Biological: serogroup B meningococcal vaccine |
| Arm 2: rMenB + OMV | Experimental | Biological: serogroup B meningococcal vaccine |
| Arm 3: Placebo | Placebo comparator | Biological: serogroup B meningococcal vaccine |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy Adolescents between and including 11-18 years of age, who provide written informed consent.
Key exclusion criteria (1 listed)
- Previous or suspected disease caused by N. meningitidis; or previous immunization with a serogroup B meningococcal vaccine; Any acute, chronic or progressive 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 |
|---|---|---|
| serogroup B meningococcal vaccine0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule. | Biological | Arm 1: rMenB |
| serogroup B meningococcal vaccine0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule. | Biological | Arm 2: rMenB + OMV |
| serogroup B meningococcal vaccine0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule. | Biological | Arm 3: Placebo |
Primary outcome
Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents
Time frame: 1 month after completion of immunization schedule
1 secondary outcome
Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents
Time frame: 6 months after completion of immunization schedule
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 1 Dec 2016.
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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.
Novartis Vaccines - Drug Information Services study chair
Novartis
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing serogroup B meningococcal vaccine in people with Meningococcal Disease, run by Novartis Vaccines at 8 sites 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 1 inclusion and 1 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 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. 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 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, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents (time frame: 1 month after completion of immunization schedule). 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 1 Dec 2016.