MeningitisPhase 2NCT00700635

Dose Comparison Study of Menactra® in US Children

A Phase 2 study testing Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate in people with Meningitis and Meningococcal Infection, run by Sanofi Pasteur, a Sanofi Company at 15 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

To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children. Primary Objective: To assess, by age group, the immune response to Menactra vaccine after each vaccine injection. Read more about this study

Who is it for?: Ages 2 to 10 yearsHealthy volunteers can take part
Conditions the study is for: Meningitis, Meningococcal Infection, Neisseria Meningitidis
What is being tested?: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 333 participants
Where: 15 sitesUnited States
Study dates: Jun 2008to Oct 2009
Phase: Phase 2
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 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 2 to < 11 years on the day of inclusion.
Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative.
Subject and parent/legal guardian able to attend all scheduled visits and comply with all trial procedures.

Who cannot join

Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first 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.
Suspected or known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a product containing any of the substances present in the study vaccine .
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.

Show all 15Show fewer

Receipt of blood or blood-derived products in the past 3 months.
Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first trial vaccination.
Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s).
Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity.
History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically).
Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination.
Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws.
Personal or family history of Guillain-Barré Syndrome (GBS).
Any condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Study site
Boca Raton, Florida, 33433
Study site
Charleston, South Carolina, 29425
Study site
Cleveland, Ohio, 44121
Study site
Fort Worth, Texas, 76135
Study site
Jonesboro, Arkansas, 72401
Study site
Kingsport, Tennessee, 37660
Study site
Las Vegas, Nevada, 89102
Study site
Little Rock, Arkansas, 72205
Study site
Midlothian, Virginia, 23113
Study site
Orem, Utah, 84057
Study site
Pittsburgh, Pennsylvania, 15241
Study site
San Antonio, Texas, 78205
Study site
Spokane, Washington, 99202
Study site
Viera, Florida, 32940
Study site
Woburn, Massachusetts, 01801

Other trials in United States

About this study

Official title: Exploratory Evaluation of a Two-dose Schedule Versus a One-dose Schedule of Menactra® (Meningococcal [Groups A, C, Y and W 135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) in Children in the US

To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children.

Primary Objective:

To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.

Read the detailed description

This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.

Conditions: Meningitis, Meningococcal Infection, Neisseria Meningitidis
Being tested: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
Keywords: Meningitis; Meningococcal infection, Neisseria meningitidis
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.

Menactra®: Meningococcal Polysaccharide Diphtheria ConjugateBiological
Also called Menactra®
0.5 mL, 2 doses Intramuscular
Menactra®: Meningococcal Polysaccharide Diphtheria ConjugateBiological
Also called Menactra®
0.5 mL, 2 doses Intramuscular
Menactra®: Meningococcal Polysaccharide Diphtheria ConjugateBiological
Also called Menactra®
0.5 mL, 1 dose Intramuscular

Study groups in NCT00700635
Study group	Role	What they receive
Menactra® Group 1	Experimental	Participants aged 2 to < 4 years Receives: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
Menactra® Group 2	Experimental	Participants aged 4 to < 6 years Receives: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
Menactra® Group 3	Active comparator	Participants aged 6 to < 11 years Receives: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

What is being measured

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

Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Measured: 30 days post-vaccination

Secondary outcomes (4)

Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Measured: 30 days post-vaccination
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Measured: 30 days post-vaccination
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Measured: 7 days post-vaccination 1
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Measured: 7 days post-vaccination 2

Timeline

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

Jun 2008Oct 2009

First posted19 Jun 2008 (estimated)
Study startJun 2008
Primary completionMay 2009
Study completionOct 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 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 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 333 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00700635
Sponsor's protocol ID: MTA61
Status last verified: Apr 2016
First submitted: 7 May 2008
Last updated: 14 Apr 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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All Meningitis trials

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: Exploratory Evaluation of a Two-dose Schedule Versus a One-dose Schedule of Menactra® (Meningococcal [Groups A, C, Y and W 135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) in Children in the US
ClinicalTrials.gov ID: NCT00700635
Acronym / sponsor ID: MTA61
Conditions: Meningitis, Meningococcal Infection, Neisseria Meningitidis
Keywords: Meningitis; Meningococcal infection, Neisseria meningitidis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 333 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: May 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 19 Jun 2008 (estimated)
Results: Posted 23 Dec 2010

Clinical summary

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

To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children.

Primary Objective:

To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.

Detailed description

This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Menactra® Group 1	Experimental	Biological: Menactra®: Meningococcal Polysaccharide Diphtheria ConjugateParticipants aged 2 to < 4 years
Menactra® Group 2	Experimental	Biological: Menactra®: Meningococcal Polysaccharide Diphtheria ConjugateParticipants aged 4 to < 6 years
Menactra® Group 3	Active comparator	Biological: Menactra®: Meningococcal Polysaccharide Diphtheria ConjugateParticipants aged 6 to < 11 years

Who may qualify

Ages: 2 to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Aged 2 to < 11 years on the day of inclusion.
Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative.
Subject and parent/legal guardian able to attend all scheduled visits and comply with all trial procedures.

Key exclusion criteria (15 listed)

Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first 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.
Suspected or known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a product containing any of the substances present in the study vaccine .

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®: Meningococcal Polysaccharide Diphtheria ConjugateAlso: Menactra®0.5 mL, 2 doses Intramuscular	Biological	Menactra® Group 1
Menactra®: Meningococcal Polysaccharide Diphtheria ConjugateAlso: Menactra®0.5 mL, 2 doses Intramuscular	Biological	Menactra® Group 2
Menactra®: Meningococcal Polysaccharide Diphtheria ConjugateAlso: Menactra®0.5 mL, 1 dose Intramuscular	Biological	Menactra® Group 3

Primary outcome

Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Time frame: 30 days post-vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)

4 secondary outcomes

Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Time frame: 30 days post-vaccination
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Time frame: 30 days post-vaccination
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Time frame: 7 days post-vaccination 1
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Time frame: 7 days post-vaccination 2

Results and safety

Results posted to the registry on 23 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Menactra® Group 1	111	100
Menactra® Group 2	111	103
Menactra® Group 3	111	110

Primary outcome: Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination

Time frame: 30 days post-vaccination. Number. Unit: Percentage of Participants

Measure	Menactra® Group 1 n = 82	Menactra® Group 2 n = 89	Menactra® Group 3 n = 108
Serogroup A Post-dose 1 ≥ 8 [n = 82, 89, 107]	59	36	65
Serogroup A Post-dose 2 ≥ 8 [n = 81, 89, 0]	83	67	NA
Serogroup C Post-dose 1 ≥ 8 [n = 82, 89, 108]	72	51	62
Serogroup C Post-dose 2 ≥ 8 [n = 82, 89, 0]	95	88	NA
Serogroup Y Post-dose 1 ≥ 8 [n = 82, 89, 108]	60	65	71
Serogroup Y Post-dose 2 ≥ 8 [n = 82, 89, 0]	100	96	NA
Serogroup W-135 Post-dose 1 ≥ 8 [n = 82, 89, 108]	66	79	91
Serogroup W-135 Post-dose 2 ≥ 8 [n = 82, 89, 0]	96	96	NA

Population analysed: Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Menactra® Group 1	4 of 111 (3.6%)	58 of 111 (52.3%)	Not reported
Menactra® Group 2	3 of 111 (2.7%)	57 of 111 (51.4%)	Not reported
Menactra® Group 3	0 of 111 (0%)	64 of 111 (57.7%)	Not reported

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.

15 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 3 inclusion and 15 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 15 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Dec 2010). 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 ≥ 8 After Each Vaccination (time frame: 30 days post-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 NCT00700635.

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.