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Meningococcal MeningitisPhase 3NCT00384397

A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers

A Phase 3 study testing Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine and Meningococcal Polysaccharide Diphtheria Toxoid Conjugate in people with Meningococcal Meningitis and Measles, run by Sanofi Pasteur, a Sanofi Company at 39 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

This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12… Read more about this study

Who is it for?
Ages 249 to 305 daysHealthy volunteers can take part
Conditions the study is for
Meningococcal Meningitis, Measles, Mumps
What is being tested?
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine and Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,128 participants
Where
39 sitesUnited States
Study dates
Sep 2006to Feb 2009
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 249 to 305 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy, as determined by medical history and physical examination.
  • Aged 9 months (249 to 291 days) at the time of enrollment.
  • The parent or legal guardian has signed and dated the Institutional Review Board-approved informed consent form

Who cannot join

  • Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, or autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion.
  • Known or suspected impairment of immunologic function.
  • Acute medical illness within the last 72 hours, or temperature ≥ 100.4 ºF (≥ 38.0 ºC) at the time of enrollment.
  • History of documented invasive meningococcal disease or previous meningococcal vaccination.
  • Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian
  • 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 two weeks prior to enrollment. Topical steroids are not included in this exclusion criterion.
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  • Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops are not included in this exclusion criterion.
  • Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing the same substances. For ProQuad vaccine recipients, this includes a hypersensitivity to gelatin or a history of anaphylactic reactions to neomycin.
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination.
  • Parent or legal guardian unable or unwilling to comply with the study procedures.
  • Participation in another interventional clinical trial in the 30 days preceding enrollment, or participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period.
  • Diagnosed with 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.
  • Received any vaccine in the 30-day period prior to receipt of study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of any study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or two weeks after receiving the study vaccines. Subjects should not have received their 4th dose of Pneumococcal Conjugate (PCV) or Hib vaccine or their first dose of Measles-Mumps-Rubella-Varicella (MMRV) vaccine before enrollment.
  • Personal or family history of Guillain-Barré Syndrome (GBS).
  • History of seizures, including febrile seizures, or any other neurologic disorder.
  • Known hypersensitivity to dry natural rubber latex (pertinent to the Menactra® vaccine needle shield)

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Bardstown, Kentucky, 40004

  • Study site

    Bridgeton, Missouri, 63044

  • Study site

    Chapel Hill, North Carolina, 27514

  • Study site

    Charlottesville, Virginia, 22911

  • Study site

    Cincinnati, Ohio, 45229-3039

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Cocoa Beach, Florida, 32931

  • Study site

    Columbus, Ohio, 43205

  • Study site

    Fayetteville, Arkansas, 72703

  • Study site

    Fort Worth, Texas, 76107

  • Study site

    Goldsboro, North Carolina, 27534

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    La Crosse, Wisconsin, 54601

  • Study site

    Las Vegas, Nevada, 89104

  • Study site

    Laurinburg, North Carolina, 28352

  • Study site

    Layton, Utah, 84041

  • Study site

    Little Rock, Arkansas, 72202-3591

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Marietta, Georgia, 30062

  • Study site

    Midlothian, Virginia, 23113

  • Study site

    Montgomery, Alabama, 36106

  • Study site

    Norfolk, Virginia, 23510

  • Study site

    Norwich, Connecticut, 06360

  • 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

    Spokane, Washington, 99220

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Sylva, North Carolina, 28779

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tulsa, Oklahoma, 74127

  • Study site

    Viera, Florida, 32955

  • Study site

    Woburn, Massachusetts, 01801

Other trials in United States

About this study

Official title: An Immunogenicity and Safety Evaluation of Two Doses of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Given to Healthy Subjects at 9 and 12 Months of Age

This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age.

Primary Objective:

Read more

To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135.

Secondary Objectives:

Immunogenicity

  • To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines.
  • To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with PCV vaccine.

Safety

  • To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events (SAEs) throughout the course of the study.
Being tested
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine, Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Keywords
Menactra vaccine, Meningococcal meningitis, Measles, Mumps, Rubella, Varicella virus, Haemophilus influenzae type b, Pneumococcal conjugate vaccine
Medical subject headings
Meningitis, Meningococcal, Measles, Mumps, Rubella, Chickenpox, Haemophilus Infections

What participants receive

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

  • Meningococcal Polysaccharide Diphtheria Toxoid Conjugate VaccineBiological

    Also called Menactra®

    0.5 mL, Intramuscular

  • Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBiological

    Also called Menactra®, ProQuad®

    0.5 mL, Intramuscular

  • Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBiological

    Also called Menactra®, Prevnar®

    0.5 mL, Intramuscular

Study groups in NCT00384397
Study groupRoleWhat they receive
Group 1: Menactra® VaccineExperimentalParticipants will receive Menactra® vaccine at age 9 months and 12 months, respectively.
Receives: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Group 2: Menactra® + MMRVExperimentalParticipants will receive Menactra® at age 9 months followed by Menactra® and Measles-Mumps-Rubella-Varicella (MMRV) vaccines at Age 12 Months
Receives: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Group 3: Menactra® + PCVExperimentalParticipants will receive Menactra® at age 9 months followed by Menactra® and Pneumococcal Conjugate (PCV) vaccines at Age 12 Months
Receives: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

What is being measured

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

  1. Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)

    Measured: 30 days post-visit 2 Menactra®

Secondary outcomes (1)

  1. Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination

    Injection site reactions: tenderness, erythema, and swelling at the Menactra site (Visits 1 and 2) and the measles-mumps-rubella, varicella (MMRV) and pneumococcal conjugate vaccine (PCV) sites (only Visit 2); Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability following each vaccination.

    Measured: 0-7 days post-vaccination

Timeline

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

  1. First posted6 Oct 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionAug 2008
  4. Study completionFeb 2009

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00384397
Sponsor's protocol ID
MTA44
Status last verified
Apr 2016
First submitted
5 Oct 2006
Last updated
14 Apr 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine and Meningococcal Polysaccharide Diphtheria Toxoid Conjugate in people with Meningococcal Meningitis and Measles, run by Sanofi Pasteur, a Sanofi Company at 39 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 3 inclusion and 16 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 39 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 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 2 Jun 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?

Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) (time frame: 30 days post-visit 2 Menactra®). 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 NCT00384397.

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.

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