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

Primary Purpose

Meningococcal Meningitis, Measles, Mumps

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
Measles, Mumps, Rubella and Varicella
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Meningitis focused on measuring Menactra vaccine, Meningococcal meningitis, Measles, Mumps, Rubella, Varicella vaccines, Haemophilus influenzae type b, Pneumococcal conjugate vaccine

Eligibility Criteria

9 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Menactra® at 9 and 12 Months

Menactra® at 9 Months and Menactra® + MMRV at 12 Months

Menactra® at 9 Months and Menactra® + PCV at 12 Months

MMRV + PCV at 12 Months

Arm Description

Participants will received Menactra® vaccination at 9 and 12 months of age.

Participants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age

Participants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 12, 2007
Last Updated
April 12, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00422292
Brief Title
Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Meningitis, Measles, Mumps, Rubella, Varicella
Keywords
Menactra vaccine, Meningococcal meningitis, Measles, Mumps, Rubella, Varicella vaccines, Haemophilus influenzae type b, Pneumococcal conjugate vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1664 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Menactra® at 9 and 12 Months
Arm Type
Experimental
Arm Description
Participants will received Menactra® vaccination at 9 and 12 months of age.
Arm Title
Menactra® at 9 Months and Menactra® + MMRV at 12 Months
Arm Type
Experimental
Arm Description
Participants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age
Arm Title
Menactra® at 9 Months and Menactra® + PCV at 12 Months
Arm Type
Experimental
Arm Description
Participants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Arm Title
MMRV + PCV at 12 Months
Arm Type
Active Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
Other Intervention Name(s)
Menactra®
Intervention Description
0.5 mL dose, intramuscular (IM)
Intervention Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
Other Intervention Name(s)
Menactra®
Intervention Description
0.5 mL dose, IM
Intervention Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
Other Intervention Name(s)
Menactra®
Intervention Description
0.5 Ml dose, IM
Intervention Type
Biological
Intervention Name(s)
Measles, Mumps, Rubella and Varicella
Other Intervention Name(s)
ProQuad®, M-M-R®II
Intervention Description
0.5 mL dose, SC
Primary Outcome Measure Information:
Title
Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)
Description
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.
Time Frame
Day 30 after the 12-month vaccination
Title
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
Other Pre-specified Outcome Measures:
Title
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
Title
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age
Description
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.
Time Frame
Days 0 to 7 after vaccination
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35401
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Atascadero
State/Province
California
ZIP/Postal Code
93422
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
City
Viera
State/Province
Florida
ZIP/Postal Code
32940
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
City
Dalton
State/Province
Georgia
ZIP/Postal Code
30721
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
City
Tifton
State/Province
Georgia
ZIP/Postal Code
31794
Country
United States
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60647
Country
United States
City
Fishers
State/Province
Indiana
ZIP/Postal Code
46038
Country
United States
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
Country
United States
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52002
Country
United States
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
City
Perry Hall
State/Province
Maryland
ZIP/Postal Code
21128
Country
United States
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
City
Niles
State/Province
Michigan
ZIP/Postal Code
49120
Country
United States
City
Stevensville
State/Province
Michigan
ZIP/Postal Code
49127
Country
United States
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
City
La Vista
State/Province
Nebraska
ZIP/Postal Code
68128
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68117
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68132
Country
United States
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89105
Country
United States
City
Whitehouse Station
State/Province
New Jersey
ZIP/Postal Code
08889
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
City
Fishkill
State/Province
New York
ZIP/Postal Code
12524
Country
United States
City
Hopewell Junction
State/Province
New York
ZIP/Postal Code
12533
Country
United States
City
Ithaca
State/Province
New York
ZIP/Postal Code
14850
Country
United States
City
Lake Success
State/Province
New York
ZIP/Postal Code
11021
Country
United States
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
City
Clyde
State/Province
North Carolina
ZIP/Postal Code
28721
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
City
Strongsville
State/Province
Ohio
ZIP/Postal Code
44136
Country
United States
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15220
Country
United States
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Lehi
State/Province
Utah
ZIP/Postal Code
84043
Country
United States
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
City
St. George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
City
Urem
State/Province
Utah
ZIP/Postal Code
84057
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23113
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

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

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