Meningococcal InfectionPhase 3NCT01086969

A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India

A Phase 3 study testing Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®) in people with Meningococcal Infection and Meningitis, run by Sanofi at 3 sites in India.

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 safety and immunogenicity of a single dose of Menactra® vaccine to support registration. Primary Objectives: To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination. Read more about this study

Who is it for?: Ages 2 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Infection, Meningitis
What is being tested?: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 3 sitesIndia
Study dates: Jun 2010to Jun 2011
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 2 to 55 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Aged 2 to 11 years or Aged 12 to 17 years or Aged 18 to 55 years of age on the day of inclusion
For participants aged 2 to 11 years: Provision of informed consent form signed by the parent(s) or legal representative.
For participants aged 12 to 17 years: Provision of assent form signed by the participant and informed consent form signed by the parent(s) or legal representative.
For participants aged 18 to 55 years: Provision of informed consent form signed by the participant. If the participant or the participant's parents or legally accepted representative (participants aged 2 to 17 years) are illiterate, an independent witness is required to sign the consent form.
Participant and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures
For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for participants aged 2 to 17 years' females not of child-bearing potential or not sexually active)

Who cannot join

For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for participants aged 2 to 17 years' females not of child-bearing potential or not sexually active)
Breast-feeding woman
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
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
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances

Show all 19Show fewer

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 response
Receipt or planned receipt of any vaccine (other than influenza vaccine which can be given 2 weeks or more before vaccination) in the 4 weeks preceding or following the trial vaccination
Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen , or Hepatitis C seropositivity as reported by the participant/parent/guardian and/or based on medical history
History of documented invasive meningococcal disease
Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
Personal or family history of Guillain-Barré Syndrome
Temporary contraindications delaying vaccination until resolved:
Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of vaccination
Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw

Trial locations and contacts

3 sites in 1 country.

India3 sites

Study site
Bangalore, 560070
Study site
Mumbai, 400022
Study site
New Delhi, 110002

Other trials in India

About this study

Official title: Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India

The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration.

Primary Objectives:

To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination.
To describe the safety profile of participants after one dose of Menactra®.

Read the detailed description

Participants will be enrolled in three age cohorts: Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age to receive a single dose of Menactra®. They will be followed for a duration of 30 days after vaccination.

Conditions: Meningococcal Infection, Meningitis
Being tested: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)
Keywords: Meningococcal Infection, Meningitis, Bacterial, Menactra®
Medical subject headings: Meningococcal Infections, Meningitis, Meningitis, Bacterial

What participants receive

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

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)Biological
Also called Menactra®
0.5 mL, Intramuscular

Study groups in NCT01086969
Study group	Role	What they receive
Study Group	Experimental	Participants in three age cohorts - Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age will be enrolled. Receives: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)

What is being measured

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

Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.
Measured: Baseline and 21 days post-vaccination
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Measured: Day 0 and Day 30 post-vaccination
Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination
Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Measured: Day 0 to 30 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia
Measured: Day 0 to 7 post-vaccination

Timeline

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

Jun 2010Jun 2011

First posted15 Mar 2010 (estimated)
Study startJun 2010
Primary completionFeb 2011
Study completionJun 2011

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 InfectionStudies of the same condition, open and under way.
More trials run by SanofiThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01086969
Sponsor's protocol ID: MTA51
Other IDs: UTN: U1111-1111-5608
Status last verified: Feb 2012
First submitted: 11 Mar 2010
Last updated: 6 Feb 2012
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

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingObservational study
National Bacterial Meningitis Study in Children and Newborns
Meningitis, Children, Only
Active, not recruitingPhase 4
A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
Meningitis, Meningococcal

All Meningococcal Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India
ClinicalTrials.gov ID: NCT01086969
Acronym / sponsor ID: MTA51
Conditions: Meningococcal Infection, Meningitis
Keywords: Meningococcal Infection, Meningitis, Bacterial, Menactra®
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Feb 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 15 Mar 2010 (estimated)
Results: Posted 3 Feb 2012

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 safety and immunogenicity of a single dose of Menactra® vaccine to support registration.

Primary Objectives:

To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination.
To describe the safety profile of participants after one dose of Menactra®.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study Group	Experimental	Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)Participants in three age cohorts - Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age will be enrolled.

Who may qualify

Ages: 2 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Aged 2 to 11 years or Aged 12 to 17 years or Aged 18 to 55 years of age on the day of inclusion
For participants aged 2 to 11 years: Provision of informed consent form signed by the parent(s) or legal representative.
For participants aged 12 to 17 years: Provision of assent form signed by the participant and informed consent form signed by the parent(s) or legal representative.
For participants aged 18 to 55 years: Provision of informed consent form signed by the participant. If the participant or the participant's parents or legally accepted representative (participants aged 2 to 17 years) are illiterate, an independent witness is required to sign the consent form.
Participant and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures

Key exclusion criteria (19 listed)

For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for participants aged 2 to 17 years' females not of child-bearing potential or not sexually active)
Breast-feeding woman
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
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

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 Conjugate (Menactra®)Also: Menactra®0.5 mL, Intramuscular	Biological	Study Group

Primary outcome

Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Time frame: Baseline and 21 days post-vaccination
Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Time frame: Day 0 and Day 30 post-vaccination
Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination
Time frame: Day 0 to 30 post-vaccination
Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Time frame: Day 0 to 7 post-vaccination
Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia

Results and safety

Results posted to the registry on 3 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Age 2 to 11 Years Group	100	99
Age 12 to 17 Years Group	100	98
Age 18 to 55 Years Group	100	100

Primary outcome: Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination

Time frame: Baseline and 21 days post-vaccination. Number. Unit: Participants

Measure	Age 2 to 11 Years Group n = 100	Age 12 to 17 Years Group n = 100	Age 18 to 55 Years Group n = 100
Serogroup A (Pre-vaccination; N= 100, 100, 100)	17	27 (0 to 0)	23 (0 to 0)
Serogroup A (Post-vaccination; N= 99, 97, 98)	95	94 (0 to 0)	97 (0 to 0)
Serogroup C (Pre-vaccination; N= 100, 100, 100)	24	43 (0 to 0)	66 (0 to 0)
Serogroup C (Post-vaccination; N= 99, 98, 100)	91	95 (0 to 0)	99 (0 to 0)
Serogroup Y (Pre-vaccination; N= 100, 100, 100)	92	92 (0 to 0)	89 (0 to 0)
Serogroup Y (Post-vaccination; N= 99, 97, 98)	99	97 (0 to 0)	98 (0 to 0)
Serogroup W-135 (Pre-vaccination; N=100, 100, 100)	54	68 (0 to 0)	52 (0 to 0)
Serogroup W-135 (Post-vaccination; N= 99, 97, 99)	96	97 (0 to 0)	99 (0 to 0)

Population analysed: Menactra vaccine antibody titers were determined in the immunogenicity analysis set.

Primary outcome: Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination

Time frame: Day 0 and Day 30 post-vaccination. Geometric mean (95% Confidence Interval). Unit: 1/dilution (1/dil)

Measure	Age 2 to 11 Years Group n = 100	Age 12 to 17 Years Group n = 100	Age 18 to 55 Years Group n = 100
Serogroup A (Pre-vaccination; N= 100, 100, 100)	9.51 (6.43 to 14.1)	15.0 (9.65 to 23.4)	9.78 (6.90 to 13.9)
Serogroup A (Post-vaccination; N= 99, 97, 98)	1145 (854 to 1536)	1324 (1002 to 1750)	2261 (1749 to 2924)
Serogroup C (Pre-vaccination; N= 100, 100, 100)	9.92 (7.01 to 14.0)	17.9 (12.2 to 26.2)	56.9 (36.6 to 88.3)
Serogroup C (Post-vaccination; N= 99, 98, 100)	610 (392 to 949)	2343 (1563 to 3512)	7486 (5380 to 10417)
Serogroup Y (Pre-vaccination; N= 100, 100, 100)	355 (256 to 491)	309 (222 to 430)	156 (110 to 222)
Serogroup Y (Post-vaccination; N= 99, 97, 98)	1964 (1607 to 2399)	3190 (2502 to 4067)	3926 (2855 to 5398)
Serogroup W-135 (Pre-vaccination; N=100, 100, 100)	31.3 (20.6 to 47.7)	47.8 (32.3 to 70.9)	28.6 (18.6 to 44.1)
Serogroup W-135 (Post-vaccination; N= 99, 97, 99)	1756 (1240 to 2486)	2538 (1947 to 3307)	3183 (2360 to 4293)

Population analysed: Geometric mean titers were determined in the immunogenicity analysis set

Primary outcome: Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination

Time frame: Day 0 to 30 post-vaccination. Number. Unit: Percentage of Participants

Measure	Age 2 to 11 Years Group n = 100	Age 12 to 17 Years Group n = 100	Age 18 to 55 Years Group n = 100
Serogroup A (N = 99, 97, 98)	85	85 (0 to 0)	96 (0 to 0)
Serogroup C (N = 99, 98, 100)	88	91 (0 to 0)	96 (0 to 0)
Serogroup Y (N = 99, 97, 98)	68	75 (0 to 0)	89 (0 to 0)
Serogroup W-135 (N = 99, 97, 99)	93	96 (0 to 0)	97 (0 to 0)

Population analysed: Four-fold antibody increase were determined in the immunogenicity analysis set

Primary outcome: Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination

Time frame: Day 0 to 7 post-vaccination. Number. Unit: Participants

Measure	Age 2 to 11 Years Group n = 100	Age 12 to 17 Years Group n = 100	Age 18 to 55 Years Group n = 100
Any Solicited injection site pain	30	23 (0 to 0)	38 (0 to 0)
Grade 3 pain (Incapacitating)	0	0 (0 to 0)	0 (0 to 0)
Any Solicited injection site erythema	7	1 (0 to 0)	0 (0 to 0)
Grade 3 erythema (≥5 cm [2-11 years] or >10 cm)	0	0 (0 to 0)	0 (0 to 0)
Any Solicited injection site swelling	10	4 (0 to 0)	0 (0 to 0)
Grade 3 swelling (≥5 cm [2-11 years] or >10 cm)	0	0 (0 to 0)	0 (0 to 0)
Any Solicited fever	11	3 (0 to 0)	5 (0 to 0)
Grade 3 fever (≥ 39.0°C)	3	2 (0 to 0)	2 (0 to 0)

Population analysed: Safety parameters were assessed in the safety analysis set

Adverse events

Time frame: Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Age 2 to 11 Years Group	0 of 100 (0%)	30 of 100 (30%)	Not reported
Age 12 to 17 Years Group	0 of 100 (0%)	23 of 100 (23%)	Not reported
Age 18 to 55 Years Group	0 of 100 (0%)	38 of 100 (38%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Meningococcal Infection

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
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RecruitingPhase 3
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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®) in people with Meningococcal Infection and Meningitis, run by Sanofi at 3 sites in India.

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 19 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 6 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in India. 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 3 Feb 2012). 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?

Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination (time frame: Baseline and 21 days post-vaccination). The study lists 4 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 NCT01086969.

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 6 Feb 2012; AzTrials last refreshed its copy on 8 Nov 2026.