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Meningococcal MeningitisPhase 3NCT00422292

Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers

A Phase 3 study testing Meningococcal Polysaccharide Diphtheria Conjugate Vaccine and Measles, Mumps, Rubella and Varicella in people with Meningococcal Meningitis and Measles, run by Sanofi Pasteur, a Sanofi Company at 88 sites in 2 countries.

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 modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers. Primary Objectives: To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine. Read more about this study

Who is it for?
Ages 9 to 12 monthsHealthy volunteers can take part
Conditions the study is for
Meningococcal Meningitis, Measles, Mumps
What is being tested?
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine and Measles, Mumps, Rubella and Varicella
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,664 participants
Where
88 sitesin 2 countries
Study dates
Dec 2006to Apr 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 9 to 12 months
  • 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) for Groups 1, 2, and 3 or aged 12 months (365 to 386 days) for Group 4 at the time of enrollment
  • The parent or legal guardian has signed and dated the Institutional Review Board (IRB)-approved informed consent form.

Who cannot join

  • Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, 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 a temperature ≥ 100.4ºF (≥38.0ºC) 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 any blood draw. Topical antibiotics and 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 planned 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 the study vaccines, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccines. 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 fourth dose of Pneumococcal conjugate vaccine (PCV) or Haemophilus influenzae type b (Hib) vaccine or their first dose of Measles, mumps, rubella, varicella (MMRV) vaccine before enrollment or been scheduled to receive these vaccines outside of the study-specified visits.
  • 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.

Trial locations and contacts

88 sites in 2 countries.

88 sites in 2 countries

United States87 sites

  • Study site

    Atascadero, California, 93422

  • Study site

    Aurora, Colorado, 80012

  • Study site

    Beachwood, Ohio, 44122

  • Study site

    Bellevue, Nebraska, 68123

  • Study site

    Boone, North Carolina, 28607

  • Study site

    Bossier City, Louisiana, 71111

  • Study site

    Bridgeton, Missouri, 63044

  • Study site

    Brooklyn, New York, 11201

  • Study site

    Charlottesville, Virginia, 22902

  • Study site

    Charlottesville, Virginia, 22903

  • Study site

    Charlottesville, Virginia, 22911

  • Study site

    Chicago, Illinois, 60614

  • Study site

    Chicago, Illinois, 60647

  • Study site

    Clarksville, Tennessee, 37043

  • Study site

    Cleveland, Ohio, 44121

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Clyde, North Carolina, 28721

  • Study site

    Dalton, Georgia, 30721

  • Study site

    Dubuque, Iowa, 52001

  • Study site

    Dubuque, Iowa, 52002

  • Study site

    Durham, North Carolina, 27704

  • Study site

    Durham, North Carolina, 27705

  • Study site

    Fishers, Indiana, 46038

  • Study site

    Fishkill, New York, 12524

  • Study site

    Fresno, California, 93726

  • Study site

    Harleysville, Pennsylvania, 19438

  • Study site

    Henderson, Nevada, 89105

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Hopewell Junction, New York, 12533

  • Study site

    Houston, Texas, 77004

  • Study site

    Huntington, West Virginia, 25701

  • Study site

    Independence, Ohio, 44131

  • Study site

    Ithaca, New York, 14850

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Kansas City, Missouri, 64108

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    La Vista, Nebraska, 68128

  • Study site

    Lake Success, New York, 11021

  • Study site

    Lehi, Utah, 84043

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Longview, Texas, 75605

  • Study site

    Marietta, Georgia, 30062

  • Study site

    Marshfield, Wisconsin, 54449

  • Study site

    Midlothian, Virginia, 23113

  • Study site

    Mineola, New York, 11501

  • Study site

    Morgantown, West Virginia, 26506

  • Study site

    New York, New York, 10016

  • Study site

    Niles, Michigan, 49120

  • Study site

    Norwich, Connecticut, 06360

  • Study site

    Ogden, Utah, 84405

  • Study site

    Omaha, Nebraska, 68117

  • Study site

    Omaha, Nebraska, 68124

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Omaha, Nebraska, 68132

  • Study site

    Owensboro, Kentucky, 42303

  • Study site

    Paramount, California, 90723

  • Study site

    Perry Hall, Maryland, 21128

  • Study site

    Pittsburgh, Pennsylvania, 15220

  • Study site

    Pleasant Grove, Utah, 84062

  • Study site

    Poughkeepsie, New York, 12603

  • Study site

    Provo, Utah, 84604

  • Study site

    Richmond, Virginia, 23219

  • Study site

    Roseville, California, 95661

  • Study site

    Sacramento, California, 95823

  • Study site

    Saint Charles, Missouri, 63303

  • Study site

    San Antonio, Texas, 78205

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Jose, California, 95119

  • Study site

    Sellersville, Pennsylvania, 18960

  • Study site

    South Jordan, Utah, 84095

  • Study site

    Springville, Utah, 84663

  • Study site

    St Louis, Missouri, 63104

  • Study site

    St. George, Utah, 84790

  • Study site

    Stevensville, Michigan, 49127

  • Study site

    Strongsville, Ohio, 44136

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tifton, Georgia, 31794

  • Study site

    Torrance, California, 90502

  • Study site

    Tucson, Arizona, 85741

  • Study site

    Tuscaloosa, Alabama, 35401

  • Study site

    Urem, Utah, 84057

  • Study site

    Viera, Florida, 32940

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Wexford, Pennsylvania, 15090

  • Study site

    Whitehouse Station, New Jersey, 08889

  • Study site

    Woburn, Massachusetts, 01801

  • Study site

    Woodstock, Georgia, 30189

Other trials in United States

Puerto Rico1 site

  • Study site

    San Juan, PR, 00918

Other trials in Puerto Rico

About this study

Official title: An Immunogenicity, Safety, and Non-Interference Evaluation of Pediatric Vaccines Administered Concomitantly With Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) to Healthy Toddlers

This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.

Primary Objectives:

Read more
  • To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine.
  • To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine.

Observational Objectives:

Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination[s]) in subjects in the study groups.

Immunogenicity:

  • To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.
Read the detailed description

No meningococcal vaccine is presently licensed for the population aged < 2 years in the US, establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against invasive meningococcal disease in children aged < 2 years would address this important, currently unmet public health need.

At enrollment, each 9-month old subject will be randomly assigned to a study group and vaccinated. A second vaccination will be administered at 12 months of age. Subjects will provide one blood sample during the trial.

Twelve-month old subjects will also be vaccinated with routine pediatric vaccines and provide one blood sample 30 days after vaccinations in the control group

Being tested
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine, Measles, Mumps, Rubella and Varicella
Keywords
Menactra vaccine, Meningococcal meningitis, Measles, Mumps, Rubella, Varicella vaccines, 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 Conjugate VaccineBiological

    Also called Menactra®

    0.5 mL dose, intramuscular (IM)

  • Meningococcal Polysaccharide Diphtheria Conjugate VaccineBiological

    Also called Menactra®

    0.5 mL dose, IM

  • Meningococcal Polysaccharide Diphtheria Conjugate VaccineBiological

    Also called Menactra®

    0.5 Ml dose, IM

  • Measles, Mumps, Rubella and VaricellaBiological

    Also called ProQuad®, M-M-R®II

    0.5 mL dose, SC

Study groups in NCT00422292
Study groupRoleWhat they receive
Menactra® at 9 and 12 MonthsExperimentalParticipants will received Menactra® vaccination at 9 and 12 months of age.
Receives: Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
Menactra® at 9 Months and Menactra® + MMRV at 12 MonthsExperimentalParticipants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age
Receives: Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
Menactra® at 9 Months and Menactra® + PCV at 12 MonthsExperimentalParticipants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Receives: Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
MMRV + PCV at 12 MonthsActive comparatorParticipants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Receives: Biological: Measles, Mumps, Rubella and Varicella

What is being measured

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

  1. Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)

    Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.

    Measured: Day 30 after the 12-month vaccination

  2. Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4

    Measured: Day 30 after the 12-month vaccination

Timeline

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

  1. First posted15 Jan 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionJan 2009
  4. Study completionApr 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
Investigator
Enrolment
1,664 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00422292
Sponsor's protocol ID
MTA37
Status last verified
Apr 2016
First submitted
12 Jan 2007
Last updated
14 Apr 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal Polysaccharide Diphtheria Conjugate Vaccine and Measles, Mumps, Rubella and Varicella in people with Meningococcal Meningitis and Measles, run by Sanofi Pasteur, a Sanofi Company at 88 sites in 2 countries.

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 88 sites in United States, Puerto Rico. 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?

Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) (time frame: Day 30 after the 12-month vaccination). 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 NCT00422292.

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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