A Phase 4 interventional study of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Meningitis, Meningococcal Meningitis and Meningococcal Infections, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-07.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 4, Interventional, and Treatment
Among 22 studies in Meningitis, Meningococcal by Sanofi Pasteur, a Sanofi Company — none open to participants now, none under way, none of them phase 3. Meningitis, Meningococcal · Sanofi Pasteur, a Sanofi Company.
Among the 22 studies in Meningitis, Meningococcal by Sanofi Pasteur, a Sanofi Company, this one is the 19th largest by enrollment of the 21 interventional ones, is one of 3 that started in 2015, is one of 3 in phase 4, and was the 9th registered.
125 studies on the registry are indexed under Meningitis, Meningococcal; 10 are open to participants now.
This study's enrollment of 110 is below the median of 538 across 113 interventional studies indexed under Meningitis, Meningococcal.
Browse Meningitis, Meningococcal studies →None of the 22 studies in Meningitis, Meningococcal by Sanofi Pasteur, a Sanofi Company is open now.
Of the 5 Meningitis, Meningococcal studies recruiting now, 0 (0%) set no upper age limit and 5 (100%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2015.
Median enrollment 918 across the 21 interventional studies, 100 across the 1 observational. Of the 22 that completed or were terminated, 20 (91%) have results posted.
Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Meningitis, Meningococcal by Sanofi Pasteur, a Sanofi Company, from their registry updates:
Nothing recorded among them since 2026-09-25.
The aim of this study is to provide information on the persistence of bactericidal antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675).
Objective:
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)
125 studies on the registry are indexed under Meningitis, Meningococcal; 10 are open to participants now.
This study's enrollment of 110 is below the median of 538 across 113 interventional studies indexed under Meningitis, Meningococcal.
Browse Meningitis, Meningococcal studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
Compared within Meningitis, Meningococcal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Meningitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received a booster dose of Menactra vaccine approximately four years earlier
Biological: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be administered in this trial
Also known as: Menactra®
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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-booster, 28 Days and 4 years post-booster vaccination
Study participants were enrolled from 15 December 2015 to 28 December 2015 at 4 clinic sites in the United States.
| Milestone | All Subjects; Menactra Vaccine |
|---|---|
| Started | 110 |
| Completed | 109 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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 | All Subjects; Menactra Vaccine |
|---|---|
| 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 |
| Serogroup Y; 4 years post-booster (N=109) | 98.2 |
| Serogroup W-135; Pre-booster (N=108) | 83.3 |
| Serogroup W-135; 28 days post-booster (N=109) | 100.0 |
| Serogroup W-135; 4 years post-booster (N=109) | 97.2 |
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 | All Subjects; Menactra Vaccine |
|---|---|
| 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 |
| Serogroup Y; 4 years post-booster (N=109) | 97.2 |
| Serogroup W-135; Pre-booster (N=108) | 72.2 |
| Serogroup W-135; 28 days post-booster (N=109) | 100.0 |
| Serogroup W-135; 4 years post-booster (N=109) | 95.4 |
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
| Titers (1/dilution) | All Subjects; Menactra Vaccine |
|---|---|
| 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) |
| Serogroup Y; 4 years post-booster (N=109) | 120 (88.9 to 162.3) |
| Serogroup W-135; Pre-booster (N=108) | 13.4 (10.4 to 17.3) |
| Serogroup W-135; 28 days post-booster (N=109) | 1170 (881.5 to 1553.8) |
| Serogroup W-135; 4 years post-booster (N=109) | 93.1 (69.4 to 125.0) |
Collected over Monitoring of safety events was limited to serious adverse events considered related to study procedures (i.e., collection of the blood sample).. Non-serious events are listed at a 5.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Subjects; Menactra Vaccine | — | 0/110 (0%) | 0/110 (0%) |
| Age, Categorical(Participants) | All Subjects; Menactra Vaccine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 110 |
| >=65 years | 0 |
| Age, Continuous(Years) | All Subjects; Menactra Vaccine |
|---|---|
| Mean | 22.2 ± 3.54 |
| Sex: Female, Male(Participants) | All Subjects; Menactra Vaccine |
|---|---|
| Female | 61 |
| Male | 49 |
| Region of Enrollment(Participants) | All Subjects; Menactra Vaccine |
|---|---|
| United States | 110 |
The record gives a start of Dec 2015, a primary completion of Feb 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2016, 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company →