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Meningococcal MeningitisPhase 3NCT00483574

Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers

A Phase 3 study testing Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate, Measles-mumps-rubella-varicella vaccine and Routine paediatric vaccine - Pneumococcal conjugate (PCV) in people with Meningococcal Meningitis and Measles, run by Sanofi Pasteur, a Sanofi Company at 79 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 clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US. 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?
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate, Measles-mumps-rubella-varicella vaccine and Routine paediatric vaccine - Pneumococcal conjugate (PCV)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,378 participants
Where
79 sitesin 2 countries
Study dates
May 2007to 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 305 days) or 12 months (365 to 400 days) at the time of enrollment
  • The parent or legal guardian has signed and dated the Independent Ethics Committee (IEC)-/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.
  • Has received the fourth dose of Prevnar, or the first dose of measles-mumps-rubella (MMR), varicella, or hepatitis A (HepA) vaccine.
  • Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian.
Show all 18Show fewer
  • Received either immune globulin or other blood products within the last 3 months.
  • Suspected or known hypersensitivity to any of the vaccine components.
  • 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 the study vaccine(s), or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccine(s).
  • 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.
  • For the subjects scheduled to provide blood samples:
  • Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to either of the study blood draws. Topical antibiotics and antibiotic drops are not included in this exclusion criterion.

Trial locations and contacts

79 sites in 2 countries.

79 sites in 2 countries

United States78 sites

  • Study site

    Amarillo, Texas, 79106

  • Study site

    Amarillo, Texas, 79124

  • Study site

    Arkansas City, Kansas, 67005

  • Study site

    Barnwell, South Carolina, 29812

  • Study site

    Barrington, Rhode Island, 02806

  • Study site

    Bellingham, Washington, 98226

  • Study site

    Bentonville, Arkansas, 72712

  • Study site

    Birmingham, Alabama, 35205

  • Study site

    Birmingham, Alabama, 35244

  • Study site

    Boise, Idaho, 83704

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Carrollton, Texas, 75007

  • Study site

    Centennial, Colorado, 80112

  • Study site

    Chandler, Arizona, 85234

  • Study site

    Cincinnati, Ohio, 45245

  • Study site

    Clifton, New Jersey, 07013

  • Study site

    Conway, Arkansas, 72034

  • Study site

    Dothan, Alabama, 36305

  • Study site

    Downy, California, 90241

  • Study site

    Endwell, New York, 13760

  • Study site

    Evansville, Indiana, 47710

  • Study site

    Fairfield, Ohio, 45014

  • Study site

    Fall River, Massachusetts, 02724

  • Study site

    Fargo, North Dakota, 58104

  • Study site

    Fort Worth, Texas, 76012

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Garner, North Carolina, 27529

  • Study site

    Grapevine, Texas, 76057

  • Study site

    Hardy, Arkansas, 72542

  • Study site

    Houston, Texas, 77065

  • Study site

    Houston, Texas, 77084

  • Study site

    Huber Heights, Ohio, 45424

  • Study site

    Huntington Beach, California, 92647

  • Study site

    Huntington Park, California, 90255

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Kettering, Ohio, 45429

  • Study site

    La Jolla, California, 92037

  • Study site

    LaCosta, California, 92009

  • Study site

    Lake Mary, Florida, 32746

  • Study site

    Lexington, Kentucky, 40503

  • Study site

    Liverpool, New York, 13088

  • Study site

    Longmont, Colorado, 80501

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Louisville, Kentucky, 40207

  • Study site

    Louisville, Kentucky, 40272

  • Study site

    Mason, Ohio, 45040

  • Study site

    Meadowbrook, Pennsylvania, 19046

  • Study site

    Minot, North Dakota, 58701

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Newport News, Virginia, 23606

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Philadelphia, Pennsylvania, 19114

  • Study site

    Philadelphia, Pennsylvania, 19116

  • Study site

    Pico Rivera, California, 90660

  • Study site

    Pinson, Alabama, 35126

  • Study site

    Pittsburgh, Pennsylvania, 15217

  • Study site

    Poland, Ohio, 44514

  • Study site

    Providence, Rhode Island, 02903

  • Study site

    Raleigh, North Carolina, 27615

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Stone Mountain, Georgia, 30087

  • Study site

    Sugar Land, Texas, 77479

  • Study site

    Tampa, Florida, 33614

  • Study site

    Thornton, Colorado, 80233

  • Study site

    Tomball, Texas, 77375

  • Study site

    Tullahoma, Tennessee, 37388

  • Study site

    Tuscaloosa, Alabama, 35406

  • Study site

    Utica, New York, 13502

  • Study site

    Vienna, Virginia, 22180

  • Study site

    Warwick, Rhode Island, 02886

  • Study site

    Watertown, South Dakota, 57201

  • Study site

    West Valley City, Utah, 84120

  • Study site

    Wichita, Kansas, 67207

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Youngstown, Ohio, 44505

Other trials in United States

Chile1 site

  • Study site

    Santiago

Other trials in Chile

About this study

Official title: Safety Study of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered With Other Pediatric Vaccines to Healthy Toddlers

This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US.

Safety Objective:

To describe the safety profile of two doses of Menactra® Vaccine.

Being tested
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate, Measles-mumps-rubella-varicella vaccine, Routine paediatric vaccine - Pneumococcal conjugate (PCV), Routine paediatric vaccine - Hepatitis A
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.

  • Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBiological

    Also called Menactra®

    0.5 mL, IM at age 9 and 12 months

  • Measles-mumps-rubella-varicella vaccineBiological

    Also called MMRV: ProQuad

    0.5 mL, intramuscular at 12 months of age

  • Routine paediatric vaccine - Pneumococcal conjugate (PCV)Biological

    Also called Pneumococcal conjugate (PCV),

    0.5 mL, Intramuscular at age 12 months

  • Routine paediatric vaccine - Hepatitis ABiological

    Also called Hepatitis A

    0.5 mL, Intramuscular at age 12 months

Study groups in NCT00483574
Study groupRoleWhat they receive
Group 1: Menactra® and Routine Pediatric VaccinesExperimentalParticipants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate [PCV], and hepatitis A [HepA]) at age 12 months.
Receives: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Biological: Measles-mumps-rubella-varicella vaccine; Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV); Biological: Routine paediatric vaccine - Hepatitis A
Group 2: Routine Pediatric VaccinesOtherParticipants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months.
Receives: Biological: Measles-mumps-rubella-varicella vaccine; Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV); Biological: Routine paediatric vaccine - Hepatitis A

What is being measured

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

  1. Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.

    Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling.

    Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability

    Measured: Day 0 to 7 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 posted7 Jun 2007 (estimated)
  2. Study startMay 2007
  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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00483574
Sponsor's protocol ID
MTA48
Status last verified
Apr 2016
First submitted
6 Jun 2007
Last updated
16 May 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate, Measles-mumps-rubella-varicella vaccine and Routine paediatric vaccine - Pneumococcal conjugate (PCV) in people with Meningococcal Meningitis and Measles, run by Sanofi Pasteur, a Sanofi Company at 79 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 18 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 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, Chile. 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 6 Jul 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 at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. (time frame: Day 0 to 7 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 NCT00483574.

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 16 May 2016.

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