MeningitisPhase 2NCT00772629
Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults
A Phase 2 study testing Meningococcal Polysaccharide Diphtheria Toxoid Conjugate in people with Meningitis and Meningococcemia, run by Sanofi Pasteur, a Sanofi Company at 2 sites in United Kingdom.
Trial summary
This study was designed to generate data for the assessment of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®) when given to adults aged 18 to 55 years. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcemia
- What is being tested?
- Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2004to Apr 2004
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant was at least 18 years of age but not yet 56 years of age at the time of vaccination.
- Participant had received either unconjugated meningococcal polysaccharide (serogroups A and C, or A, C, Y, and W 135) vaccine at least one year prior to enrollment (for assignment to Group 2) or had no prior history of meningococcal vaccination (for assignment to Group 1).
- Participant had signed Ethics Committee-approved informed consent form.
Who cannot join
- Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.)
- Known or suspected impairment of immunologic function
- Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 38°C at the time of inclusion
- History of documented invasive meningococcal disease
- Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days were allowed to be included in the trial as long as they had not received more than one course within the last two weeks prior to enrollment.
- Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to drawing the blood sample at Visit 2
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- Received unconjugated meningococcal polysaccharide (serogroups A and C, or A, C, Y, and W 135) vaccine within the one-year period prior to enrollment or a conjugated meningococcal vaccine at any time prior to enrollment
- Received any vaccine in the 28-day period prior to enrollment, or scheduled to receive any vaccination during participation in the study
- Suspected or known hypersensitivity to any of the vaccine components
- Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures
- Enrolled in another clinical trial
- In females, pregnancy confirmed by positive urine test result
- In females, current breastfeeding.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults Who Were Either Previously Vaccinated With Unconjugated Meningococcal Polysaccharide (Serogroups A, C or Serogroups A, C, Y, and W-135) Vaccine or Not Vaccinated With Meningococcal Vaccine
This study was designed to generate data for the assessment of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®) when given to adults aged 18 to 55 years.
Primary Objective:
Read more
To describe the antibody response to each serogroup prior to, and 4 to 6 weeks following, the administration of one dose of the investigational Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®), as measured by serum bactericidal activity using baby rabbit complement (SBA BR) in participants in each of the two study groups.
Secondary Objective:
To collect reference sera for the development and refinement of laboratory assays for the measurement of antibody responses to serogroups Y and W 135.
Read the detailed description
Enrollment was terminated before the planned sample size was achieved because the principal investigator and the Sponsor decided that sufficient sera had been obtained to meet the secondary objective of the study.
There were no safety concerns involved in the decision to stop enrollment. Subjects that were enrolled at the time completed the study as per protocol, the last subject last visit was on 29 April 2004.
- Conditions
- Meningitis, Meningococcemia
- Being tested
- Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Keywords
- Menactra®, Meningitis, Meningococcemia, Neisseria meningitidis
- Medical subject headings
- Meningitis, Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBiological
Also called Menactra®
0.5 mL, Intramuscular
Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBiological
Also called Menactra®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects naïve to any meningococcal vaccination Receives: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate |
| Group 2 | Experimental | Subjects who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135) Receives: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28.
Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.
Measured: Day 28 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startJan 2004
- Primary completionApr 2004
- Study completionApr 2004
Why it stopped: See detailed description for termination reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MeningitisStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772629
- Sponsor's protocol ID
- MTA16
- Status last verified
- Jan 2014
- First submitted
- 13 Oct 2008
- Last updated
- 14 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults Who Were Either Previously Vaccinated With Unconjugated Meningococcal Polysaccharide (Serogroups A, C or Serogroups A, C, Y, and W-135) Vaccine or Not Vaccinated With Meningococcal Vaccine
- ClinicalTrials.gov ID
- NCT00772629
- Acronym / sponsor ID
- MTA16
- Conditions
- Meningitis, Meningococcemia
- Keywords
- Menactra®, Meningitis, Meningococcemia, Neisseria meningitidis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See detailed description for termination reason
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Posted 27 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to generate data for the assessment of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®) when given to adults aged 18 to 55 years.
Primary Objective:
To describe the antibody response to each serogroup prior to, and 4 to 6 weeks following, the administration of one dose of the investigational Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®), as measured by serum bactericidal activity using baby rabbit complement (SBA BR) in participants in each of the two study groups.
Secondary Objective:
To collect reference sera for the development and refinement of laboratory assays for the measurement of antibody responses to serogroups Y and W 135.
Detailed description
Enrollment was terminated before the planned sample size was achieved because the principal investigator and the Sponsor decided that sufficient sera had been obtained to meet the secondary objective of the study.
There were no safety concerns involved in the decision to stop enrollment. Subjects that were enrolled at the time completed the study as per protocol, the last subject last visit was on 29 April 2004.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateSubjects naïve to any meningococcal vaccination |
| Group 2 | Experimental | Biological: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateSubjects who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participant was at least 18 years of age but not yet 56 years of age at the time of vaccination.
- Participant had received either unconjugated meningococcal polysaccharide (serogroups A and C, or A, C, Y, and W 135) vaccine at least one year prior to enrollment (for assignment to Group 2) or had no prior history of meningococcal vaccination (for assignment to Group 1).
- Participant had signed Ethics Committee-approved informed consent form.
Key exclusion criteria (13 listed)
- Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.)
- Known or suspected impairment of immunologic function
- Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 38°C at the time of inclusion
- History of documented invasive meningococcal disease
- Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days were allowed to be included in the trial as long as they had not received more than one course within the last two weeks prior to enrollment.
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 Polysaccharide Diphtheria Toxoid ConjugateAlso: Menactra®0.5 mL, Intramuscular | Biological | Group 1 |
| Meningococcal Polysaccharide Diphtheria Toxoid ConjugateAlso: Menactra®0.5 mL, Intramuscular | Biological | Group 2 |
Primary outcome
Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28.
Time frame: Day 28 post-vaccination
Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink 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.
Medical Monitor study director
Sanofi Pasteur Inc.
2 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 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate in people with Meningitis and Meningococcemia, run by Sanofi Pasteur, a Sanofi Company at 2 sites in United Kingdom.
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 3 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 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?
Yes. Results are posted in the registry (first posted 27 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28. (time frame: Day 28 post-vaccination). 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 14 Feb 2014.