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

Condition(s) targeted: Meningococcal Meningitis; Measles; Mumps; Rubella; Varicella

Intervention: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine (Biological); Meningococcal Polysaccharide Diphtheria Conjugate Vaccine (Biological); Measles, Mumps, Rubella and Varicella (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: sanofi pasteur

Overall contact:
Public Registry, Email: RegistryContactUs@sanofipasteur.com

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.

Study design: Prevention, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To provide information concerning the immune response of MMRV, Hib, and PCV after vaccination.

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

Minimum age: 9 Months. Maximum age: 12 Months. Gender(s): Both.

Criteria:

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

Public Registry, Email: RegistryContactUs@sanofipasteur.com

Paramount, California 90723, United States; Recruiting

Omaha, Nebraska 68131, United States; Recruiting

Poughkeepsie, New York 12603, United States; Recruiting

Sylva, North Carolina 28779, United States; Recruiting

Cincinnati, Ohio 45245, United States; Recruiting

Pittsburgh, Pennsylvania 15241, United States; Recruiting

Hershey, Pennsylvania 17033, United States; Recruiting

San Antonio, Texas 78229, United States; Recruiting

Dallas, Texas 75234, United States; Recruiting

Ogden, Utah 84405, United States; Recruiting

Salt Lake City, Utah 84123, United States; Recruiting

St. George, Utah 84790, United States; Recruiting

Marshfield, Wisconsin 54449, United States; Recruiting

Starting date: December 2006
Ending date: October 2008
Last updated: February 6, 2008