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

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ClinicalTrials.gov Identifier: NCT00422292
Recruitment Status : Completed
First Posted : January 15, 2007
Results First Posted : June 2, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE January 12, 2007
First Posted Date  ICMJE January 15, 2007
Results First Submitted Date  ICMJE May 10, 2011
Results First Posted Date  ICMJE June 2, 2011
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE December 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
  • 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 ]
    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.
  • Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 [ Time Frame: Day 30 after the 12-month vaccination ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00422292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 10, 2014)
  • Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 [ Time Frame: Day 30 after 12-month vaccination ]
  • Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age [ Time Frame: Days 0 to 7 after vaccination ]
    Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling. Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability.
  • Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age [ Time Frame: Days 0 to 7 after vaccination ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
Official Title  ICMJE 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
Brief 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.
  • 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.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningococcal Meningitis
  • Measles
  • Mumps
  • Rubella
  • Varicella
Intervention  ICMJE
  • Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
    0.5 mL dose, intramuscular (IM)
    Other Name: Menactra®
  • Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
    0.5 mL dose, IM
    Other Name: Menactra®
  • Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
    0.5 Ml dose, IM
    Other Name: Menactra®
  • Biological: Measles, Mumps, Rubella and Varicella
    0.5 mL dose, SC
    Other Names:
    • ProQuad®
    • M-M-R®II
Study Arms  ICMJE
  • Experimental: Menactra® at 9 and 12 Months
    Participants will received Menactra® vaccination at 9 and 12 months of age.
    Intervention: Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
  • Experimental: Menactra® at 9 Months and Menactra® + MMRV at 12 Months
    Participants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age
    Intervention: Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
  • Experimental: Menactra® at 9 Months and Menactra® + PCV at 12 Months
    Participants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
    Intervention: Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
  • Active Comparator: MMRV + PCV at 12 Months
    Participants 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
    Intervention: Biological: Measles, Mumps, Rubella and Varicella
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2009)
1664
Original Enrollment  ICMJE
 (submitted: January 12, 2007)
2150
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • 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.

Exclusion Criteria :

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Months to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00422292
Other Study ID Numbers  ICMJE MTA37
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP