MeningitisPhase 2NCT00643916

Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age

A Phase 2 study testing Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®) and A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®) in people with Meningitis and Meningococcal Infection, run by Sanofi Pasteur, a Sanofi Company at 14 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 purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age. Primary Objective: To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9… Read more about this study

Who is it for?: Ages 9 months to 5 yearsHealthy volunteers can take part
Conditions the study is for: Meningitis, Meningococcal Infection
What is being tested?: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®) and A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 378 participants
Where: 14 sitesUnited States
Study dates: Dec 2004to Oct 2007
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 9 months to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged either 9, 12, 15 or 18 months of age or 3 to < 6 years of age on the day of inclusion.
Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian
Able to attend all scheduled visits and to comply with all trial procedures

Who cannot join

History of a serious chronic disease that could interfere with trial conduct or completion.
Known or suspected impairment of immunologic function.
Acute medical illness with or without fever within the last 72 hours, or rectal temperature ≥ 100.4°F (≥ 38.0°C) or axillary temperature ≥ 99.4°F (≥ 37.4°C) on the day of inclusion.
History of invasive meningococcal disease (confirmed either clinically, serologically or microbiologically) or previous meningococcal vaccination.
Administration of immune globulin or other blood products within 3 months, or oral or parenteral corticosteroids or other immunosuppressive therapy within the last 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
Antibiotic therapy within the 72 hours prior to having any blood sample drawn.

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Received or scheduled to receive any vaccine in the 28-day period prior to receipt of either dose of the study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 28-day period after receipt of either dose of the study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or after receiving the trial vaccine.
Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
Unable to attend one or more of the scheduled visits or to comply with the study procedures.
Participation in another clinical trial in the 4 weeks preceding enrollment.
Planned participation in another clinical trial during the present trial period.
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

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Study site
Akron, Ohio, 44308
Study site
Atlanta, Georgia, 30322
Study site
Baltimore, Maryland, 21201
Study site
Bardstown, Kentucky, 40004
Study site
Columbus, Ohio, 43205
Study site
Drexel Hill, Pennsylvania, 19026
Study site
Kingsport, Tennessee, 37664
Study site
Little Rock, Arkansas, 72205
Study site
Marietta, Georgia, 30062
Study site
Norwich, Connecticut, 06360
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Salt Lake City, Utah, 84123
Study site
Sellersville, Pennsylvania, 18960
Study site
Woburn, Massachusetts, 01801

Other trials in United States

About this study

Official title: Safety and Immunogenicity of a Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine (TetraMenD) In Toddlers 9 to 18 Months of Age

The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age.

Primary Objective:

To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to <6 years of age.

Read the detailed description

This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.

Conditions: Meningitis, Meningococcal Infection
Being tested: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®), A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Keywords: Meningitis; Meningococcal Infection
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 Polysaccharide Diphtheria Protein Conjugate (Menactra®)Biological
Also called Menactra®
0.5 mL, Intramuscular (at age 9 and 12 months)
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Biological
Also called Menactra®
0.5 mL, Intramuscular (at age 9 and 15 months)
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Biological
Also called Menactra®
0.5 mL, Intramuscular (at age 12 and 15 months)
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Biological
Also called Menactra®
0.5 mL, Intramuscular (at age 15 months)
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Biological
Also called Menactra®
0.5 mL, Intramuscular (at age 18 months)
A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)Biological
Also called Menomune®
0.5 mL, Subcutaneous (at 3 years to <6 years of age)

Study groups in NCT00643916
Study group	Role	What they receive
Vaccinated at Age 9 and 12 Months	Experimental	Participants received Menactra® vaccine at 9 and 12 Months of age Receives: Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Vaccinated at Age 9 and 15 Months	Experimental	Participants received Menactra® vaccine at 9 and 15 Months of age Receives: Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Vaccinated at Age 12 and 15 Months	Experimental	Participants received Menactra® vaccine at Age 12 and 12 Months of age Receives: Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Vaccinated at Age 15 Months	Experimental	Participants received Menactra® vaccine at 15 Months of age Receives: Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Vaccinated at Age 18 Months	Experimental	Participants received Menactra® vaccine at 18 Months of age Receives: Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Vaccinated at Age 3 Years to <6 Years	Active comparator	Participants received Menomune® vaccine at Age 3 years to <6 years of age Receives: Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)

What is being measured

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

Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Measured: Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2

Timeline

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

Dec 2004Oct 2007

First posted26 Mar 2008 (estimated)
Study startDec 2004
Primary completionMar 2006
Study completionOct 2007

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: 378 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00643916
Sponsor's protocol ID: MTA26
Status last verified: Jan 2014
First submitted: 24 Mar 2008
Last updated: 14 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of a Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine (TetraMenD) In Toddlers 9 to 18 Months of Age
ClinicalTrials.gov ID: NCT00643916
Acronym / sponsor ID: MTA26
Conditions: Meningitis, Meningococcal Infection
Keywords: Meningitis; Meningococcal Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 378 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2004
Primary completion: Mar 2006 (actual)
Study completion: Oct 2007 (actual)
First posted: 26 Mar 2008 (estimated)
Results: Posted 8 Jan 2010

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 clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age.

Primary Objective:

Detailed description

This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Vaccinated at Age 9 and 12 Months	Experimental	Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Participants received Menactra® vaccine at 9 and 12 Months of age
Vaccinated at Age 9 and 15 Months	Experimental	Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Participants received Menactra® vaccine at 9 and 15 Months of age
Vaccinated at Age 12 and 15 Months	Experimental	Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Participants received Menactra® vaccine at Age 12 and 12 Months of age
Vaccinated at Age 15 Months	Experimental	Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Participants received Menactra® vaccine at 15 Months of age
Vaccinated at Age 18 Months	Experimental	Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Participants received Menactra® vaccine at 18 Months of age
Vaccinated at Age 3 Years to <6 Years	Active comparator	Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)Participants received Menomune® vaccine at Age 3 years to <6 years of age

Who may qualify

Ages: 9 months to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Aged either 9, 12, 15 or 18 months of age or 3 to < 6 years of age on the day of inclusion.
Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian
Able to attend all scheduled visits and to comply with all trial procedures

Key exclusion criteria (13 listed)

History of a serious chronic disease that could interfere with trial conduct or completion.
Known or suspected impairment of immunologic function.
Acute medical illness with or without fever within the last 72 hours, or rectal temperature ≥ 100.4°F (≥ 38.0°C) or axillary temperature ≥ 99.4°F (≥ 37.4°C) on the day of inclusion.
History of invasive meningococcal disease (confirmed either clinically, serologically or microbiologically) or previous meningococcal vaccination.
Administration of immune globulin or other blood products within 3 months, or oral or parenteral corticosteroids or other immunosuppressive therapy within the last 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.

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 Protein Conjugate (Menactra®)Also: Menactra®0.5 mL, Intramuscular (at age 9 and 12 months)	Biological	Vaccinated at Age 9 and 12 Months
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Also: Menactra®0.5 mL, Intramuscular (at age 9 and 15 months)	Biological	Vaccinated at Age 9 and 15 Months
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Also: Menactra®0.5 mL, Intramuscular (at age 12 and 15 months)	Biological	Vaccinated at Age 12 and 15 Months
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Also: Menactra®0.5 mL, Intramuscular (at age 15 months)	Biological	Vaccinated at Age 15 Months
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)Also: Menactra®0.5 mL, Intramuscular (at age 18 months)	Biological	Vaccinated at Age 18 Months
A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)Also: Menomune®0.5 mL, Subcutaneous (at 3 years to <6 years of age)	Biological	Vaccinated at Age 3 Years to <6 Years

Primary outcome

Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Time frame: Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2

Results and safety

Results posted to the registry on 8 Jan 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
Vaccinated at Age 9 and 12 Months	55	51
Vaccinated at Age 9 and 15 Months	67	61
Vaccinated at Age 12 and 15 Months	68	62
Vaccinated at Age 15 Months	62	60
Vaccinated at Age 18 Months	59	57
Vaccinated at Age 3 Years to <6 Years	67	66

Primary outcome: Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.

Time frame: Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2. Number. Unit: Percentage of Participants

Measure	Vaccinated at Age 9 and 12 Months n = 40	Vaccinated at Age 9 and 15 Months n = 50	Vaccinated at Age 12 and 15 Months n = 54	Vaccinated at Age 15 Months n = 55	Vaccinated at Age 18 Months n = 51	Vaccinated at Age 3 Years to <6 Years n = 63
Meningococcal serogroup A (Baseline)	38	44	33	40	40	71
Meningococcal serogroup A (Post dose 1)	76	67	52	76	65	87
Meningococcal serogroup A (Post dose 2)	89	89	85	0	0	0
Meningococcal serogroup C (Baseline)	5	2	0	2	4	8
Meningococcal serogroup C (Post dose 1)	83	85	85	86	77	49
Meningococcal serogroup C (Post dose 2)	100	100	100	0	0	0
Meningococcal serogroup Y (Baseline)	3	0	2	2	8	8
Meningococcal serogroup Y (Post dose 1)	21	24	35	33	47	66

Population analysed: Serum Bactericidal Assay Human Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.

Adverse events

Time frame: Adverse events data were collected for 6 months post-vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vaccinated at Age 9 and 12 Months	0 of 53 (0%)	37 of 53 (69.8%)	Not reported
Vaccinated at Age 9 and 15 Months	3 of 65 (4.6%)	50 of 65 (76.9%)	Not reported
Vaccinated at Age 12 and 15 Months	4 of 65 (6.2%)	48 of 65 (73.8%)	Not reported
Vaccinated at Age 15 Months	1 of 61 (1.6%)	34 of 61 (55.7%)	Not reported
Vaccinated at Age 18 Months	5 of 57 (8.8%)	33 of 57 (57.9%)	Not reported
Vaccinated at Age 3 Years to <6 Years	3 of 67 (4.5%)	21 of 67 (31.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Meningitis

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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.

14 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 13 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 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 8 Jan 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 a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. (time frame: Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2). 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 NCT00643916.

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 Feb 2014.