MeningitisPhase 3NCT01890759

Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation

A Phase 3 study testing Meningococcal Diphtheria Toxoid Vaccine in people with Meningitis and Meningococcal Infection, run by Sanofi Pasteur, a Sanofi Company at 8 sites in 2 countries.

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 purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers. Primary Objectives: To assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement [SBA-HC] titer ≥ 1:8) 28 days after the… Read more about this study

Who is it for?: Ages 9 to 17 monthsHealthy volunteers can take part
Conditions the study is for: Meningitis, Meningococcal Infection
What is being tested?: Meningococcal Diphtheria Toxoid Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 8 sitesin 2 countries
Study dates: 25 Jun 2013to 12 Apr 2016
Phase: Phase 3
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 9 to 17 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male and female subjects aged 9 to 17 months on the day of inclusion
Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable)
Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and to comply with all trial procedures.

Who cannot join

Participation in the 4 weeks preceding inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for:
(i) influenza vaccination, which may be received at least 2 weeks before study vaccines.
(ii) measles (M) or measles, mumps, rubella (MMR) routine vaccination, which can be administered concomitantly with the first dose of study vaccine as per routine immunization schedule
(iii) for subjects enrolled at Indian sites: oral poliomyelitis vaccine (OPV) received during National Immunization Days (NIDs) and supplementary immunization activity days (SIADs)
Previous vaccination against meningococcal disease with either the study vaccine or another meningococcal vaccine

Show all 21Show fewer

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 diseases, confirmed either clinically, serologically, or microbiologically
At high risk, in the opinion of the Investigator, for meningococcal disease during the trial
Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
Known thrombocytopenia, contraindicating intramuscular vaccination
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
In an emergency setting, or hospitalized involuntarily
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
For subjects enrolled at Indian sites: Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C).
For subjects enrolled at Russian sites: Acute disease of any severity on the day of vaccination or febrile illness (axillary temperature ≥ 37.0°C).
A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
Personal history of Guillain-Barré Syndrome.

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

India4 sites

Study site
Kolkata, West Bengal, 700017
Study site
Lucknow, 226003
Study site
Vadodara, Gujarat, 390022
Study site
Vellore, 632004

Other trials in India

Russia4 sites

Study site
Murmansk, 183031
Study site
Perm, 614066
Study site
Saint Petersburg, 197022
Study site
Yekaterinburg, 620028

Other trials in Russia

About this study

Official title: Immunogenicity and Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Subjects Aged 9 to 23 Months in India and in the Russian Federation

The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers.

Primary Objectives:

To assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement [SBA-HC] titer ≥ 1:8) 28 days after the second of 2 doses of Menactra® administered 3 to 6 months apart.

Secondary Objectives:

To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers.
To assess the safety profile of Menactra® after each and any vaccination.

Read the detailed description

Study participants will receive 2 doses on Menactra® vaccine at 3 to 6 months apart and will be monitored for safety and immunogenicity.

The planned duration of each subject's participation in the trial will be from 118 to 215 days.

Conditions: Meningitis, Meningococcal Infection
Being tested: Meningococcal Diphtheria Toxoid Vaccine
Keywords: Meningitis, Meningococcal Infection, Menactra®
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 Diphtheria Toxoid VaccineBiological
Also called Menactra®
0.5 mL, Intramuscular

Study groups in NCT01890759
Study group	Role	What they receive
Meningococcal Diphtheria Toxoid Vaccine	Experimental	Participants at age 9 to 17 months of enrollment will receive 2 doses on Menactra vaccine at 3 to 6 months apart Receives: Biological: Meningococcal Diphtheria Toxoid Vaccine

What is being measured

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

Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.
Measured: Day 0 (pre-vaccination) and Day 28 post-second vaccination

Secondary outcomes (13)

Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:8.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:8.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:4.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Injection site: Tenderness, Erythema, and Swelling. Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. Grade 3 Injection site: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced. Erythema and Swelling, ≥50 mm. Grade 3 Systemic: Fever, >39.5C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.
Measured: Day 0 up to Day 7 post-each vaccination

Timeline

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

25 Jun 201312 Apr 2016

First posted2 Jul 2013 (estimated)
Study start25 Jun 2013
Primary completion12 Apr 2016
Study completion12 Apr 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 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01890759
Sponsor's protocol ID: MTA70
Other IDs: U1111-1122-2171, CTRI/2014/12/005272
Status last verified: Mar 2022
First submitted: 27 Jun 2013
Last updated: 19 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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?

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All Meningitis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Subjects Aged 9 to 23 Months in India and in the Russian Federation
ClinicalTrials.gov ID: NCT01890759
Acronym / sponsor ID: MTA70
Conditions: Meningitis, Meningococcal Infection
Keywords: Meningitis, Meningococcal Infection, Menactra®
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 25 Jun 2013 (actual)
Primary completion: 12 Apr 2016 (actual)
Study completion: 12 Apr 2016 (actual)
First posted: 2 Jul 2013 (estimated)
Results: Posted 21 Aug 2017

Clinical summary

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

The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers.

Primary Objectives:

To assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement [SBA-HC] titer ≥ 1:8) 28 days after the second of 2 doses of Menactra® administered 3 to 6 months apart.

Secondary Objectives:

To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers.
To assess the safety profile of Menactra® after each and any vaccination.

Detailed description

Study participants will receive 2 doses on Menactra® vaccine at 3 to 6 months apart and will be monitored for safety and immunogenicity.

The planned duration of each subject's participation in the trial will be from 118 to 215 days.

Study design

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

Arm	Type	Receives
Meningococcal Diphtheria Toxoid Vaccine	Experimental	Biological: Meningococcal Diphtheria Toxoid VaccineParticipants at age 9 to 17 months of enrollment will receive 2 doses on Menactra vaccine at 3 to 6 months apart

Who may qualify

Ages: 9 to 17 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Male and female subjects aged 9 to 17 months on the day of inclusion
Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable)
Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and to comply with all trial procedures.

Key exclusion criteria (21 listed)

Participation in the 4 weeks preceding inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for:
(i) influenza vaccination, which may be received at least 2 weeks before study vaccines.
(ii) measles (M) or measles, mumps, rubella (MMR) routine vaccination, which can be administered concomitantly with the first dose of study vaccine as per routine immunization schedule
(iii) for subjects enrolled at Indian sites: oral poliomyelitis vaccine (OPV) received during National Immunization Days (NIDs) and supplementary immunization activity days (SIADs)

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 Diphtheria Toxoid VaccineAlso: Menactra®0.5 mL, Intramuscular	Biological	Meningococcal Diphtheria Toxoid Vaccine

Primary outcome

Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-second vaccination
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.

13 secondary outcomes

Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Time frame: Day 0 up to Day 7 post-each vaccination

Results and safety

Results posted to the registry on 21 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Russian Federation	100	98
India	200	188

Primary outcome: Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®

Time frame: Day 0 (pre-vaccination) and Day 28 post-second vaccination. Number. Unit: Percentage of participants

Measure	Russian Federation n = 77	India n = 169
Serogroup A; Pre vaccination 1 (N=77,169)	45.5	55.0
Serogroup A; Post vaccination 2 (N=77,166)	98.7	97.6
Serogroup C; Pre vaccination 1 (N=77,169)	6.5	4.7
Serogroup C; Post vaccination 2 (N=77,169)	92.2	95.9
Serogroup Y; Pre vaccination 1 (N=77,169)	5.2	6.5
Serogroup Y; Post vaccination 2 (N=77,169)	96.1	98.2
Serogroup W 135; Pre vaccination 1 (N=77,169)	7.8	5.3
Serogroup W 135; Post vaccination 2 (N=77,169)	100.0	99.4

Population analysed: Seroprotection was assessed in the Per Protocol Analysis Set.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Russian Federation	1 of 100 (1%)	35 of 100 (35%)	0 of 100
India	3 of 199 (1.5%)	40 of 199 (20.1%)	0 of 199

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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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 SA

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal Diphtheria Toxoid Vaccine in people with Meningitis and Meningococcal Infection, run by Sanofi Pasteur, a Sanofi Company at 8 sites in 2 countries.

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 3 inclusion and 21 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in India, Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 Aug 2017). 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 Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® (time frame: Day 0 (pre-vaccination) and Day 28 post-second 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 NCT01890759.

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 19 Apr 2022.