MeningitisPhase 2NCT00777790
Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents
A Phase 2 study testing Meningococcal Polysaccharide Diphtheria Toxoid Conjugate in people with Meningitis and Meningococcemia, run by Sanofi Pasteur, a Sanofi Company at 9 sites in United States.
Trial summary
This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02. Read more about this study
- Who is it for?
- Ages 13 to 21 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
- 241 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2004to Apr 2005
- 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 13 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participant is healthy, as determined by medical history and physical examination.
- Participant is at least 13 years of age but not yet 22 years of age at time of enrollment.
- For the Menactra® and Menomune® groups, participant received one dose of Menactra® or Menomune® in MTA02 trial and completed trial (2 blood samples, contacted for Month 6 safety follow up).
- For the Control group, participant has no previous history of any meningococcal vaccination.
- If < 18 years of age, participant has signed Institutional Review Board (IRB) approved informed assent form and his/her parent/legal guardian has signed an IRB-approved informed consent form.
- If ≥ 18 years of age, participant has signed an IRB-approved informed consent form.
- Able to provide vaccination log.
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 ≥ 100.4ºF (≥ 38.0ºC) at the time of inclusion.
- For the Menactra® and Menomune® groups, history of documented invasive meningococcal disease or previous meningococcal vaccination with the exception of meningococcal vaccination given as part of MTA02 trial.
- For the Control group, history of documented invasive meningococcal disease or previous meningococcal vaccination.
- Administration of immune globulin, other blood products within the last three months, 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 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.
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- Antibiotic therapy within the 72 hours prior to vaccination or antibiotic therapy within the 72 hours prior to having any blood sample drawn.
- Received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination.
- 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.
- In females, a positive or equivocal urine pregnancy test at the time of vaccination.
- Enrolled in another clinical trial.
- Any condition, which, in the opinion of the investigator, would pose a health risk to the participant, or interfere with the evaluation of the vaccine.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Akron, Ohio, 44308
Study site
Albany, New York, 12208
Study site
Atlanta, Georgia, 30322
Study site
Columbus, Ohio, 43205
Study site
Kingsport, Tennessee, 37660
Study site
Marietta, Georgia, 30062
Study site
Norfolk, Virginia, 23501
Study site
Sellersville, Pennsylvania, 18960
Study site
Woburn, Massachusetts, 01801
About this study
Official title: Antibody Responses to a Booster Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, Menactra® in Adolescents Who Previously Received Menomune® or Menactra®
This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02.
Primary Objective:
To evaluate the antibody responses to a booster dose of a tetravalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of Menactra® in naive adolescents.
Read the detailed description
All subjects were given a single boosting dose of Menactra® to evaluate the kinetics of the response, the magnitude and the avidity of the antibody produced.
- Conditions
- Meningitis, Meningococcemia
- Being tested
- Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Keywords
- 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
Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBiological
Also called Mneactra®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Menactra® Group | Experimental | Received Menactra® vaccine in Study MTA02 Receives: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate |
| Menomune® Group | Experimental | Received Menomune® vaccine in Study MTA02 Receives: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate |
| Control Group | Experimental | Meningococcal vaccine-naïve Control Group. Receives: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.
Measured: Day 0 and 8 and 28 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 posted22 Oct 2008 (estimated)
- Study startFeb 2004
- Primary completionApr 2004
- Study completionApr 2005
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 241 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
- NCT00777790
- Sponsor's protocol ID
- MTA19
- Status last verified
- Jan 2014
- First submitted
- 21 Oct 2008
- Last updated
- 14 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Keyserling H, Papa T, Koranyi K, Ryall R, Bassily E, Bybel MJ, Sullivan K, Gilmet G, Reinhardt A. Safety, immunogenicity, and immune memory of a novel meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in healthy adolescents. Arch Pediatr Adolesc Med. 2005 Oct;159(10):907-13. doi: 10.1001/archpedi.159.10.907.
PubMed 16203934
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 to a Booster Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, Menactra® in Adolescents Who Previously Received Menomune® or Menactra®
- ClinicalTrials.gov ID
- NCT00777790
- Acronym / sponsor ID
- MTA19
- Conditions
- Meningitis, Meningococcemia
- Keywords
- Meningitis, Meningococcemia, Neisseria meningitidis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Posted 19 Mar 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 evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02.
Primary Objective:
To evaluate the antibody responses to a booster dose of a tetravalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of Menactra® in naive adolescents.
Detailed description
All subjects were given a single boosting dose of Menactra® to evaluate the kinetics of the response, the magnitude and the avidity of the antibody produced.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Menactra® Group | Experimental | Biological: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateReceived Menactra® vaccine in Study MTA02 |
| Menomune® Group | Experimental | Biological: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateReceived Menomune® vaccine in Study MTA02 |
| Control Group | Experimental | Biological: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateMeningococcal vaccine-naïve Control Group. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Participant is healthy, as determined by medical history and physical examination.
- Participant is at least 13 years of age but not yet 22 years of age at time of enrollment.
- For the Menactra® and Menomune® groups, participant received one dose of Menactra® or Menomune® in MTA02 trial and completed trial (2 blood samples, contacted for Month 6 safety follow up).
- For the Control group, participant has no previous history of any meningococcal vaccination.
- If < 18 years of age, participant has signed Institutional Review Board (IRB) approved informed assent form and his/her parent/legal guardian has signed an IRB-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 ≥ 100.4ºF (≥ 38.0ºC) at the time of inclusion.
- For the Menactra® and Menomune® groups, history of documented invasive meningococcal disease or previous meningococcal vaccination with the exception of meningococcal vaccination given as part of MTA02 trial.
- For the Control group, history of documented invasive meningococcal disease or previous meningococcal vaccination.
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 | Menactra® Group |
| Meningococcal Polysaccharide Diphtheria Toxoid ConjugateAlso: Menactra®0.5 mL, Intramuscular | Biological | Menomune® Group |
| Meningococcal Polysaccharide Diphtheria Toxoid ConjugateAlso: Mneactra®0.5 mL, Intramuscular | Biological | Control Group |
Primary outcome
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Time frame: Day 0 and 8 and 28 days post-vaccination
Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.
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.
- Results publication: PubMed 16203934Keyserling H, Papa T, Koranyi K, Ryall R, Bassily E, Bybel MJ, Sullivan K, Gilmet G, Reinhardt A. Safety, immunogenicity, and immune memory of a novel meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in healthy adolescents. Arch Pediatr Adolesc Med. 2005 Oct;159(10):907-13. doi: 10.1001/archpedi.159.10.907.
- 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.
9 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 9 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 7 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: 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 9 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 19 Mar 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?
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. (time frame: Day 0 and 8 and 28 days post-vaccination). 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 NCT00777790, which also lists 1 linked publication.
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.