MeningitisPhase 4NCT02633787

Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier

A Phase 4 study testing Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in people with Meningitis and Meningococcal Meningitis, run by Sanofi Pasteur, a Sanofi Company at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to provide information on the persistence of bactericidal antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675). Objective: To evaluate the persistence of antibody responses (determined by a serum bactericidal assay using human complement (SBA-HC)) approximately 4… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Meningitis, Meningococcal Meningitis, Meningococcal Infections
What is being tested?: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 4 sitesUnited States
Study dates: Dec 2015to Mar 2016
Phase: Phase 4
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged ≥ 18 years on the day of inclusion
Received booster dose of Menactra vaccine in trial MTA77
Informed consent form has been signed and dated
Able to attend the scheduled visit and to comply with all trial procedures.

Who cannot join

Participation at the time of trial enrollment (or in the 4 weeks preceding trial enrollment) in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
Receipt of any meningococcal vaccine, including serogroup B meningococcal vaccine, after receipt of the booster dose of Menactra vaccine administered in trial MTA77
Receipt of immune globulins, blood or blood-derived products in the past 3 months
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
Bleeding disorder, thrombocytopenia, or receipt of anticoagulants contraindicating venipuncture at the discretion of the Investigator

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Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction
Any illness that, in the opinion of the Investigator, might interfere with trial conduct or trial results
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the blood draw. (A prospective subject should not be included in the trial until 72 hours has passed.)
Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed trial.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Study site
Bardstown, Kentucky, 40004
Study site
Layton, Utah, 84041
Study site
Niles, Michigan, 49120
Study site
Woburn, Massachusetts, 01801

Other trials in United States

About this study

Official title: Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately Four Years Earlier

The aim of this study is to provide information on the persistence of bactericidal antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675).

Objective:

To evaluate the persistence of antibody responses (determined by a serum bactericidal assay using human complement (SBA-HC)) approximately 4 years after the administration of a booster dose of Menactra vaccine in trial MTA77

Read the detailed description

All eligible subjects will provide 1 blood sample at Visit 1. The duration of each subject's participation in the trial will be the duration of 1 visit (for enrollment and blood draw)

Conditions: Meningitis, Meningococcal Meningitis, Meningococcal Infections
Being tested: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Keywords: Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®
Medical subject headings: Meningitis, Meningitis, Meningococcal, Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineBiological
Also called Menactra®
No vaccine will be administered in this trial

Study groups in NCT02633787
Study group	Role	What they receive
Study Group	Experimental	Participants received a booster dose of Menactra vaccine approximately four years earlier Receives: Biological: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Measured: Pre-booster vaccination, 28 days, and 4 years post-booster vaccination
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Measured: Pre-booster vaccination, 28 days and 4 years post-booster vaccination
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Measured: Pre-booster, 28 Days and 4 years post-booster vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015Mar 2016

First posted17 Dec 2015 (estimated)
Study startDec 2015
Primary completionFeb 2016
Study completionMar 2016

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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02633787
Sponsor's protocol ID: MTA00093
Other IDs: U1111-1161-3151
Status last verified: Sep 2016
First submitted: 15 Dec 2015
Last updated: 7 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately Four Years Earlier
ClinicalTrials.gov ID: NCT02633787
Acronym / sponsor ID: MTA00093
Conditions: Meningitis, Meningococcal Meningitis, Meningococcal Infections
Keywords: Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2015
Primary completion: Feb 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 17 Dec 2015 (estimated)
Results: Posted 7 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to provide information on the persistence of bactericidal antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675).

Objective:

To evaluate the persistence of antibody responses (determined by a serum bactericidal assay using human complement (SBA-HC)) approximately 4 years after the administration of a booster dose of Menactra vaccine in trial MTA77

Detailed description

All eligible subjects will provide 1 blood sample at Visit 1. The duration of each subject's participation in the trial will be the duration of 1 visit (for enrollment and blood draw)

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study Group	Experimental	Biological: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineParticipants received a booster dose of Menactra vaccine approximately four years earlier

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Aged ≥ 18 years on the day of inclusion
Received booster dose of Menactra vaccine in trial MTA77
Informed consent form has been signed and dated
Able to attend the scheduled visit and to comply with all trial procedures.

Key exclusion criteria (11 listed)

Participation at the time of trial enrollment (or in the 4 weeks preceding trial enrollment) in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
Receipt of any meningococcal vaccine, including serogroup B meningococcal vaccine, after receipt of the booster dose of Menactra vaccine administered in trial MTA77
Receipt of immune globulins, blood or blood-derived products in the past 3 months
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
History of meningococcal infection, confirmed either clinically, serologically, or microbiologically

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 (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineAlso: Menactra®No vaccine will be administered in this trial	Biological	Study Group

Primary outcome

Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Time frame: Pre-booster vaccination, 28 days, and 4 years post-booster vaccination
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Time frame: Pre-booster vaccination, 28 days and 4 years post-booster vaccination
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Time frame: Pre-booster, 28 Days and 4 years post-booster vaccination
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.

Results and safety

Results posted to the registry on 7 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects; Menactra Vaccine	110	109

Primary outcome: Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.

Time frame: Pre-booster vaccination, 28 days, and 4 years post-booster vaccination. Number. Unit: Percentage of participants

Measure	All Subjects; Menactra Vaccine n = 109
Serogroup A; Pre-booster (N=108)	88.0
Serogroup A; 28 days post-booster (N=109)	100.0
Serogroup A; 4 years post-booster (N=109)	98.2
Serogroup C; Pre-booster (N=108)	67.6
Serogroup C; 28 days post-booster (N=109)	100.0
Serogroup C; 4 years post-booster (N=109)	89.9
Serogroup Y; Pre-booster (N=108)	57.4
Serogroup Y; 28 days post-booster (N=109)	100.0

Population analysed: Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.

Primary outcome: Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination

Time frame: Pre-booster vaccination, 28 days and 4 years post-booster vaccination. Number. Unit: Percentage of participants

Measure	All Subjects; Menactra Vaccine n = 109
Serogroup A; Pre-booster (N=108)	67.6
Serogroup A; 28 days post-booster (N=109)	100.0
Serogroup A; 4 years post-booster (N=109)	94.5
Serogroup C; Pre-booster (N=108)	53.7
Serogroup C; 28 days post-booster (N=109)	100.0
Serogroup C; 4 years post-booster (N=109)	81.7
Serogroup Y; Pre-booster (N=108)	46.3
Serogroup Y; 28 days post-booster (N=109)	100.0

Population analysed: Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.

Primary outcome: Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination

Time frame: Pre-booster, 28 Days and 4 years post-booster vaccination. Geometric mean (95% Confidence Interval). Unit: Titers (1/dilution)

Measure	All Subjects; Menactra Vaccine n = 109
Serogroup A; Pre-booster (N=108)	9.33 (7.7 to 11.3)
Serogroup A; 28 days post-booster (N=109)	460 (348.4 to 606.2)
Serogroup A; 4 years post-booster (N=109)	57.8 (44.2 to 75.6)
Serogroup C; Pre-booster (N=108)	11.2 (8.0 to 15.8)
Serogroup C; 28 days post-booster (N=109)	1224 (930.1 to 1609.6)
Serogroup C; 4 years post-booster (N=109)	54.6 (36.8 to 81.0)
Serogroup Y; Pre-booster (N=108)	7.50 (5.6 to 10.0)
Serogroup Y; 28 days post-booster (N=109)	1650 (1301.2 to 2091.8)

Population analysed: Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.

Adverse events

Time frame: Monitoring of safety events was limited to serious adverse events considered related to study procedures (i.e., collection of the blood sample).. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects; Menactra Vaccine	0 of 110 (0%)	0 of 110 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 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.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 11 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 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 7 Nov 2016). 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 Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. (time frame: Pre-booster vaccination, 28 days, and 4 years post-booster vaccination). The study lists 3 primary outcomes in all. 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 NCT02633787.

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 7 Nov 2016.