MeningitisPhase 2NCT00258856
Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
A Phase 2 study testing Polysaccharide Diphtheria Conjugate Vaccine in people with Meningitis and Meningococcal Infection, run by Sanofi Pasteur, a Sanofi Company at 11 sites in United States.
Trial summary
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal Infection
- What is being tested?
- Polysaccharide Diphtheria Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 11 sitesUnited States
- Study dates
- Jan 2006to Nov 2007
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject is healthy, as determined by medical history.
- Subject is between the ages of 7 and 15 years (not yet 16 years).
- For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
- The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for Study MTA23.
- A negative urine pregnancy test is required for menstruating female subjects.
- Parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.
Who cannot join
- Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects from Study 603-02 who had been recruited for the follow-up challenge study)
- History of documented invasive meningococcal disease
- Received any other meningococcal vaccine
- Received any vaccine in the 28-day period prior to enrollment
- Received antibiotic therapy within the 72 hours prior to collection of a blood sample
- Actively enrolled or scheduled to be enrolled in another clinical study
Show all 15Show fewer
- Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system)
- Known or suspected impairment of immunologic function
- Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion
- Scheduled to receive any vaccination in the 7-day or 14-day period after enrollment
- Administration of immune globulin, other blood products, or corticosteroid within 8 weeks (56 days) of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
- Personal of family history of Guillain-Barres Syndrome
- 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
- Any condition which, in the opinion of the investigator, would pose a health risk to the participant.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Baltimore, Maryland, 21201-1559
Study site
Bridgeton, Missouri, 63044
Study site
Jonesboro, Arkansas, 72401
Study site
Little Rock, Arkansas, 72205
Study site
Marietta, Georgia, 30062
Study site
Norfolk, Virginia, 23510
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Rochester, New York, 14620
Study site
Salt Lake City, Utah, 84123
Study site
Sellersville, Pennsylvania, 18960
Study site
Woburn, Massachusetts, 01801
About this study
Official title: Persistence of Bactericidal Antibodies in Children Aged 7 to 15 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.
- Conditions
- Meningitis, Meningococcal Infection
- Being tested
- Polysaccharide Diphtheria Conjugate Vaccine
- Keywords
- Meningitis, Meningococcal infection, Neisseria meningitidis, Menactra®, Menomune®
- 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.
Polysaccharide Diphtheria Conjugate VaccineBiological
Also called Menactra®
0.5 mL, Intramuscular
Polysaccharide Diphtheria Conjugate VaccineBiological
Also called Menactra®
0.5 mL, Intramuscular
Polysaccharide Diphtheria Conjugate VaccineBiological
Also called Menactra®
0.5 mL, Intramuscular
Polysaccharide Diphtheria Conjugate VaccineBiological
Also called Menactra®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Menactra® Group 1 | Experimental | Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 3 and Day 7 after booster vaccination. Receives: Biological: Polysaccharide Diphtheria Conjugate Vaccine |
| Menactra® Group 2 | Experimental | Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 5 and Day 14 after booster vaccination. Receives: Biological: Polysaccharide Diphtheria Conjugate Vaccine |
| Meningococcal Vaccine-naïve Group 3 | Experimental | Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination. Receives: Biological: Polysaccharide Diphtheria Conjugate Vaccine |
| Meningococcal Vaccine-naïve Group 4 | Experimental | Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination. Receives: Biological: Polysaccharide Diphtheria Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination.
Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.
Measured: 7 or 14 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startJan 2006
- Primary completionMar 2007
- Study completionNov 2007
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
- 234 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
- NCT00258856
- Sponsor's protocol ID
- MTA23
- Status last verified
- Jan 2014
- First submitted
- 24 Nov 2005
- Last updated
- 14 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
- Persistence of Bactericidal Antibodies in Children Aged 7 to 15 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier
- ClinicalTrials.gov ID
- NCT00258856
- Acronym / sponsor ID
- MTA23
- Conditions
- Meningitis, Meningococcal Infection
- Keywords
- Meningitis, Meningococcal infection, Neisseria meningitidis, Menactra®, Menomune®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 28 Nov 2005 (estimated)
- Results
- Posted 25 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Menactra® Group 1 | Experimental | Biological: Polysaccharide Diphtheria Conjugate VaccineParticipants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 3 and Day 7 after booster vaccination. |
| Menactra® Group 2 | Experimental | Biological: Polysaccharide Diphtheria Conjugate VaccineParticipants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 5 and Day 14 after booster vaccination. |
| Meningococcal Vaccine-naïve Group 3 | Experimental | Biological: Polysaccharide Diphtheria Conjugate VaccineParticipants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination. |
| Meningococcal Vaccine-naïve Group 4 | Experimental | Biological: Polysaccharide Diphtheria Conjugate VaccineParticipants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject is healthy, as determined by medical history.
- Subject is between the ages of 7 and 15 years (not yet 16 years).
- For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
- The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for Study MTA23.
- A negative urine pregnancy test is required for menstruating female subjects.
Key exclusion criteria (15 listed)
- Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects from Study 603-02 who had been recruited for the follow-up challenge study)
- History of documented invasive meningococcal disease
- Received any other meningococcal vaccine
- Received any vaccine in the 28-day period prior to enrollment
- Received antibiotic therapy within the 72 hours prior to collection of a blood sample
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 |
|---|---|---|
| Polysaccharide Diphtheria Conjugate VaccineAlso: Menactra®0.5 mL, Intramuscular | Biological | Menactra® Group 1 |
| Polysaccharide Diphtheria Conjugate VaccineAlso: Menactra®0.5 mL, Intramuscular | Biological | Menactra® Group 2 |
| Polysaccharide Diphtheria Conjugate VaccineAlso: Menactra®0.5 mL, Intramuscular | Biological | Meningococcal Vaccine-naïve Group 3 |
| Polysaccharide Diphtheria Conjugate VaccineAlso: Menactra®0.5 mL, Intramuscular | Biological | Meningococcal Vaccine-naïve Group 4 |
Primary outcome
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
Time frame: 7 or 14 days post-vaccination
Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination. Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.
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.
11 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 Polysaccharide Diphtheria Conjugate Vaccine in people with Meningitis and Meningococcal Infection, run by Sanofi Pasteur, a Sanofi Company at 11 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 6 inclusion and 15 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 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 11 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. 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 25 Nov 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?
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. (time frame: 7 or 14 days 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; AzTrials last refreshed its copy on 8 Nov 2026.