Full Text View
Tabular View
No Study Results Posted
Related Studies
Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
This study has been completed.
Study NCT00422292   Information provided by Sanofi-Aventis
First Received: January 12, 2007   Last Updated: April 30, 2009   History of Changes

January 12, 2007
April 30, 2009
December 2006
January 2009   (final data collection date for primary outcome measure)
To provide information concerning the immune response of MMRV, Hib, and PCV after vaccination. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00422292 on ClinicalTrials.gov Archive Site
 
 
 
Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
 

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 MMRV vaccine when administered alone or concomitantly with Menactra vaccine.
  • To evaluate the antibody responses induced by 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.

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

Phase III
Interventional
Prevention, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
  • Meningococcal Meningitis
  • Measles
  • Mumps
  • Rubella
  • Varicella
  • Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
  • Biological: Measles, Mumps, Rubella and Varicella
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1664
April 2009
January 2009   (final data collection date for primary outcome measure)

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 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 PCV or Hib vaccine or their first dose of 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
Both
9 Months to 12 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00422292
Medical Monitor, Sanofi Pasteur, Inc
MTA37
Sanofi-Aventis
 
Study Director: Clinical Trials sanofi pasteur
Sanofi-Aventis
April 2009

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