Meningococcal InfectionsNCT00862277
Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine
An observational study of Meningococcal Infections and Meningitis, run by Sanofi Pasteur, a Sanofi Company at 20 sites in United States.
Trial summary
To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier Read more about this study
- Who is it for?
- Ages 14 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infections, Meningitis
- What is being tested?
- Menactra® and Menomune®
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 763 participants
- Where
- 20 sitesUnited States
- Study dates
- Dec 2008to Dec 2009
- Phase
- Observational
- 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 14 to 27 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects that previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257); or Menomune® in Study MTA04 and age-matched meningococcal vaccine-naive controls.
Who may be able to join
- For subjects aged ≥ 18 years: Informed consent form signed and dated by the subject
- For subjects aged < 18 years: Informed consent form signed and dated by the subject and the subject's parent/legal guardian
- Subject (and parent/legal guardian if subject is < 18 years of age) able to attend the scheduled visit and comply with all trial procedures
- For Group 1: Previously received only one dose of meningococcal vaccine (Menactra®, received in Study MTA04, MTA12, MTA19, or MTA21)
- For Group 2: Previously received only one dose of meningococcal vaccine (Menomune®, received in Study MTA04)
- For Group 3: Aged 14 through 27 years and never received any meningococcal vaccine
Who cannot join
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding inclusion
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy > 2 weeks
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune responses
- Known Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositivity
Show all 10Show fewer
- History of invasive meningococcal disease (confirmed either clinically, serologically, or microbiologically)
- For Groups 1 and 2: Previous vaccination (including booster) against meningococcal disease, with the exception of the Menactra® or Menomune® vaccination received in trial MTA04, MTA12, MTA19, or MTA21
- Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Received oral or injected antibiotic therapy within the 72 hours prior to the blood draw (temporary criteria)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Study site
Austintown, Ohio, 44515
Study site
Bardstown, Kentucky, 40004
Study site
Cleveland, Ohio, 44121
Study site
Erie, Pennsylvania, 16505
Study site
Fountain Valley, California, 92708
Study site
Greenville, Pennsylvania, 16125
Study site
Harleysville, Pennsylvania, 19438
Study site
Kingsport, Tennessee, 37660
Study site
Latrobe, Pennsylvania, 15650
Study site
Little Rock, Arkansas, 72205
Study site
Marietta, Georgia, 30062
Study site
Martinez, Georgia, 30907
Study site
Omaha, Nebraska, 68131
Study site
Pittsburgh, Pennsylvania, 15236
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Sellersville, Pennsylvania, 18960
Study site
Spokane, Washington, 99202
Study site
Spokane, Washington, 99218
Study site
Wexford, Pennsylvania, 15090
Study site
Woodstock, Georgia, 30189
About this study
Official title: Evaluation of the Persistence of Bactericidal Antibodies in Adolescents and Adults Who Received a Single Dose of Menactra® Four to Eight Years Earlier
To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier
Read the detailed description
Subjects who received one dose of Menactra® or Menomune® in study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257) will be eligible for enrollment in trial this study. All eligible subjects will provide a blood sample at Visit 1, after which their participation in the study will be terminated. An age-matched meningococcal-vaccine naïve control group will be recruited to provide a blood sample for baseline antibody level evaluation.
No vaccine will be administered in this study.
- Conditions
- Meningococcal Infections, Meningitis
- Being tested
- Menactra®, Menomune®
- Keywords
- Menactra®, Menomune®, Meningitis, Meningococcal Infections
- Medical subject headings
- Meningococcal Infections, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menactra®Biological
0.5 mL, Intramuscular (from a previous study)
Menomune®Biological
0.5 mL, Intramuscular (from a previous study)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Menactra® from Previous Studies | Subjects previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19, or MTA21. Receives: Biological: Menactra® | |
| Group 2: Menomune® from Previous Study | Subjects previously received only one dose of meningococcal vaccine, Menomune® in Study MTA04 Receives: Biological: Menomune® | |
| Group 3: Control | Meningococcal vaccine-naive age matched subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Measured: Day 0
Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionDec 2009
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 Meningococcal InfectionsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 763 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862277
- Sponsor's protocol ID
- MTA64
- Status last verified
- Apr 2016
- First submitted
- 13 Mar 2009
- Last updated
- 14 Apr 2016
- 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 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Persistence of Bactericidal Antibodies in Adolescents and Adults Who Received a Single Dose of Menactra® Four to Eight Years Earlier
- ClinicalTrials.gov ID
- NCT00862277
- Acronym / sponsor ID
- MTA64
- Conditions
- Meningococcal Infections, Meningitis
- Keywords
- Menactra®, Menomune®, Meningitis, Meningococcal Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 763 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Mar 2009 (estimated)
- Results
- Posted 13 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier
Detailed description
Subjects who received one dose of Menactra® or Menomune® in study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257) will be eligible for enrollment in trial this study. All eligible subjects will provide a blood sample at Visit 1, after which their participation in the study will be terminated. An age-matched meningococcal-vaccine naïve control group will be recruited to provide a blood sample for baseline antibody level evaluation.
No vaccine will be administered in this study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Menactra® from Previous Studies | – | Biological: Menactra®Subjects previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19, or MTA21. |
| Group 2: Menomune® from Previous Study | – | Biological: Menomune®Subjects previously received only one dose of meningococcal vaccine, Menomune® in Study MTA04 |
| Group 3: Control | – | –Meningococcal vaccine-naive age matched subjects |
Who may qualify
- Ages
- 14 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects that previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257); or Menomune® in Study MTA04 and age-matched meningococcal vaccine-naive controls.
Key inclusion criteria (6 listed)
- For subjects aged ≥ 18 years: Informed consent form signed and dated by the subject
- For subjects aged < 18 years: Informed consent form signed and dated by the subject and the subject's parent/legal guardian
- Subject (and parent/legal guardian if subject is < 18 years of age) able to attend the scheduled visit and comply with all trial procedures
- For Group 1: Previously received only one dose of meningococcal vaccine (Menactra®, received in Study MTA04, MTA12, MTA19, or MTA21)
- For Group 2: Previously received only one dose of meningococcal vaccine (Menomune®, received in Study MTA04)
Key exclusion criteria (10 listed)
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding inclusion
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy > 2 weeks
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune responses
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 |
|---|---|---|
| Menactra®0.5 mL, Intramuscular (from a previous study) | Biological | Group 1: Menactra® from Previous Studies |
| Menomune®0.5 mL, Intramuscular (from a previous study) | Biological | Group 2: Menomune® from Previous Study |
Primary outcome
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Time frame: Day 0
Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- 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 Director study director
Sanofi Pasteur Inc.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningococcal Infections and Meningitis, run by Sanofi Pasteur, a Sanofi Company at 20 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 10 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 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2011). 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 Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment (time frame: Day 0). The study lists 2 primary outcomes in all. 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 Apr 2016.