Meningococcal MeningitisPhase 2NCT00355121

Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

A Phase 2 study testing Polysaccharide Diphtheria Toxoid Conjugate Vaccine in people with Meningococcal Meningitis and Tetanus, run by Sanofi at 26 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 study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when… Read more about this study

Who is it for?: Ages 4 to 7 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Meningitis, Tetanus, Diphtheria
What is being tested?: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 882 participants
Where: 26 sitesUnited States
Study dates: Oct 2006to Jul 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 4 to 7 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy, as determined by medical history and physical examination.
Aged 4 to < 7 years at the time of study vaccination on Day 0.
Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian.
Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series.

Who cannot join

Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic)
Known or suspected impairment of immunologic function
Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment
History of documented invasive meningococcal disease or previous meningococcal vaccination
Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study.
Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting < 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrollment.

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Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw.
Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances.
Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.
Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
Enrolled in another clinical trial.
Diagnosed with any condition, which, in the opinion of the physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study.
Personal or family history of Guillain-Barré Syndrome (GBS).

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Study site
Akron, Ohio, 44308
Study site
Albuquerque, New Mexico, 87108
Study site
Atlanta, Georgia, 30322
Study site
Bardstown, Kentucky, 40004
Study site
Boulder, Colorado, 80304
Study site
Bridgeton, Missouri, 63044
Study site
Cincinnati, Ohio, 45229
Study site
Columbus, Ohio, 43205
Study site
Kingsport, Tennessee, 37660
Study site
Layton, Utah, 84041
Study site
Layton, UT 84041, Georgia, 30062
Study site
Little Rock, Arkansas, 72205
Study site
Norfolk, Virginia, 23510
Study site
Ogden, Utah, 84405
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Pleasant Grove, Utah, 84062
Study site
Provo, Utah, 84604
Study site
Rochester, New York, 14620
Study site
Salt Lake City, Utah, 84123
Study site
Sellersville, Pennsylvania, 18960
Study site
South Jordan, Utah, 84095
Study site
Spokane, Washington, 99220
Study site
St Louis, Missouri, 63141
Study site
Syracuse, New York, 13210
Study site
University Heights, Ohio, 44118
Study site
Woburn, Massachusetts, 01801

Other trials in United States

About this study

Official title: Immunogenicity and Safety of Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Children Aged 4 to 6 Years in the US When Administered Concomitantly With a Fifth Dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.

The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine.

The main objectives are:

Immunogenicity:

To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone.

Safety:

To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.

Conditions: Meningococcal Meningitis, Tetanus, Diphtheria, Pertussis, Poliomyelitis
Being tested: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Keywords: Meningococcal meningitis, Tetanus, Diphtheria, Pertussis, Poliomyelitis, Neisseria meningitidis
Medical subject headings: Meningitis, Meningococcal, Tetanus, Diphtheria, Whooping Cough, Poliomyelitis

What participants receive

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

Polysaccharide Diphtheria Toxoid Conjugate VaccineBiological
Also called Menactra®, DAPTACEL®, IPOL
0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
Polysaccharide Diphtheria Toxoid Conjugate VaccineBiological
Also called Menactra®, DAPTACEL®, IPOL
0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
Polysaccharide Diphtheria Toxoid Conjugate VaccineBiological
Also called Menactra®, DAPTACEL®, IPOL
0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)

Study groups in NCT00355121
Study group	Role	What they receive
Group 1	Experimental	DAPTACEL® + IPOL on Day 0 and Menactra on Day 30 Receives: Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Group 2	Experimental	DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30 Receives: Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Group 3	Experimental	Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30 Receives: Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

What is being measured

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

Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Measured: Day 30 post-vaccination (Visit 1)
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Measured: Day 30 post-vaccination (Visit 1)

Secondary outcomes (3)

Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).
Measured: Day 30 post-vaccination 1
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Measured: Day 30 post-vaccination
Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine
Fever was defined as a maximum oral temperature of ≥ 100.4ºF.
Measured: Day 0 through Day 7 post-vaccination at Visit 1

Timeline

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

Oct 2006Jul 2009

First posted21 Jul 2006 (estimated)
Study startOct 2006
Primary completionJun 2009
Study completionJul 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 Meningococcal MeningitisStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 882 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00355121
Sponsor's protocol ID: MTA43
Status last verified: Aug 2011
First submitted: 20 Jul 2006
Last updated: 24 Aug 2011
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 Meningococcal Meningitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Children Aged 4 to 6 Years in the US When Administered Concomitantly With a Fifth Dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.
ClinicalTrials.gov ID: NCT00355121
Acronym / sponsor ID: MTA43
Conditions: Meningococcal Meningitis, Tetanus, Diphtheria, Pertussis, Poliomyelitis
Keywords: Meningococcal meningitis, Tetanus, Diphtheria, Pertussis, Poliomyelitis, Neisseria meningitidis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 882 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Jun 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 21 Jul 2006 (estimated)
Results: Posted 23 Aug 2011

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 evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine.

The main objectives are:

Immunogenicity:

To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone.

Safety:

To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group 1	Experimental	Biological: Polysaccharide Diphtheria Toxoid Conjugate VaccineDAPTACEL® + IPOL on Day 0 and Menactra on Day 30
Group 2	Experimental	Biological: Polysaccharide Diphtheria Toxoid Conjugate VaccineDAPTACEL® + Menactra® on Day 0 and IPOL on Day 30
Group 3	Experimental	Biological: Polysaccharide Diphtheria Toxoid Conjugate VaccineMenactra® + IPOL on Day 0 and DAPTACEL® on Day 30

Who may qualify

Ages: 4 to 7 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Healthy, as determined by medical history and physical examination.
Aged 4 to < 7 years at the time of study vaccination on Day 0.
Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian.
Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series.

Key exclusion criteria (14 listed)

Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic)
Known or suspected impairment of immunologic function
Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment
History of documented invasive meningococcal disease or previous meningococcal vaccination
Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study.

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
Polysaccharide Diphtheria Toxoid Conjugate VaccineAlso: Menactra®, DAPTACEL®, IPOL0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)	Biological	Group 1
Polysaccharide Diphtheria Toxoid Conjugate VaccineAlso: Menactra®, DAPTACEL®, IPOL0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)	Biological	Group 2
Polysaccharide Diphtheria Toxoid Conjugate VaccineAlso: Menactra®, DAPTACEL®, IPOL0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)	Biological	Group 3

Primary outcome

Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
Time frame: Day 30 post-vaccination (Visit 1)
Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Time frame: Day 30 post-vaccination (Visit 1)
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)

3 secondary outcomes

Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Time frame: Day 30 post-vaccination 1
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Time frame: Day 30 post-vaccination
Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine
Time frame: Day 0 through Day 7 post-vaccination at Visit 1

Results and safety

Results posted to the registry on 23 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	353	332
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	353	324
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30	175	170

Primary outcome: Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination

Time frame: Day 30 post-vaccination (Visit 1). Number. Unit: Participants

Measure	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 n = 250	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 n = 238	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 n = 0
Diphtheria Antibody Concentration ≥ 1.0 IU/mL	249	238	–
Tetanus Antibody Concentration ≥ 1.0 IU/mL	246	236	–

Population analysed: Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)

Primary outcome: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.

Time frame: Day 30 post-vaccination (Visit 1). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 n = 0	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 n = 238	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 n = 121
Serogroup A (N = 0, 131, 104)	–	10.8 (8.7 to 13.3)	10.4 (8.1 to 13.3)
Serogroup C (N = 0, 131, 103)	–	8.1 (6.3 to 10.5)	7.8 (5.8 to 10.7)
Serogroup Y (N = 0, 131, 104)	–	18.1 (14.2 to 22.9)	26.2 (20.0 to 34.4)
Serogroup W-135 (N = 0, 131, 104)	–	22.8 (18.5 to 28.1)	21.7 (16.6 to 28.4)

Population analysed: Serum antibody titers were assessed in the per-protocol population. (Participants in Group 1 did not receive Menactra vaccine at Visit 1)

3 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	0 of 341 (0%)	236 of 341 (69.2%)	Not reported
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	2 of 344 (0.6%)	229 of 344 (66.6%)	Not reported
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30	1 of 169 (0.6%)	98 of 169 (58%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Meningococcal 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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Polysaccharide Diphtheria Toxoid Conjugate Vaccine in people with Meningococcal Meningitis and Tetanus, run by Sanofi at 26 sites in United States.

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 4 inclusion and 14 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 24 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 Aug 2011). 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 Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination (time frame: Day 30 post-vaccination (Visit 1)). The study lists 2 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 NCT00355121.

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 24 Aug 2011.