A Phase III, Partially Modified Double-blind, Randomized, Parallel-group, Active-controlled, Multi-center Study to Compare the Immunogenicity and Describe the Safety of MenACYW Conjugate Vaccine and MENVEO® When Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in the United States

Who is this study for? Infant patients with Meningococcal Meningitis
What treatments are being studied? MenACYW Vaccine
Status: Completed
Location: See all (70) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 2 months
Healthy Volunteers: t
View:

• Aged ≥ 42 to ≤ 89 days on the day of the first study visit.

• Healthy infants as determined by medical history, physical examination, and judgment of the investigator

• Informed consent form has been signed and dated by the parent(s) or guardian, and an independent witness, if required by local regulations

• Participant and parent/guardian were able to attend all scheduled visits and to comply with all trial procedures.

• Infants who received the first dose of hepatitis B vaccine at least 28 days before the first study visit

Locations
United States
Alabama
Birmingham Pediatric Associates Site Number : 8400026
Birmingham
Southeastern Pediatric Associates Site Number : 8400003
Dothan
Arkansas
Northwest Arkansas Pediatric Clinic Site Number : 8400011
Fayetteville
The Children's Clinic of Jonesboro, PA Site Number : 8400032
Jonesboro
Arizona
MedPharmics, LLC - Phoenix Site Number : 8400083
Phoenix
California
Emmaus Research Center, Inc Site Number : 8400031
Anaheim
Premier Health Research Center Site Number : 8400007
Downey
Joint Clinical Trials Huntington Park Site Number : 8400126
Huntington Park
United Clinical Research Site Number : 8400092
Huntington Park
Matrix Clinical Research Site Number : 8400095
Los Angeles
Center for Clinical Trials, LLC Site Number : 8400030
Paramount
Center for Clinical Trials of San Gabriel Site Number : 8400076
West Covina
Florida
Asclepes Research Centers Site Number : 8400064
Brooksville
Avail Clinical Research Site Number : 8400077
Deland
Next Phase Research Alliance Site Number : 8400057
Hialeah
Homestead Medical Clinic, P.A. Site Number : 8400014
Homestead
Next Phase Research Alliance Site Number : 8400040
Homestead
Children's Research, LLC Site Number : 8400063
Lake Mary
Axcess Medical Research Site Number : 8400068
Loxahatchee Groves
Acevedo Clinical Research Associates Site Number : 8400001
Miami
Florida Hospital Medical Group Pediatrics Site Number : 8400108
Orlando
IMIC Inc Site Number : 8400022
Palmetto Bay
Jedidiah Clinical Research Site Number : 8400132
Tampa
Georgia
Baybol Research Institute Site Number : 8400008
Chamblee
Idaho
Snake River Research, PLLC Site Number : 8400073
Idaho Falls
Indiana
Qualmedica Research, LLC Site Number : 8400106
Evansville
Kentucky
All Children Pediatrics Site Number : 8400043
Louisville
Brownsboro Park Pediatrics Site Number : 8400010
Louisville
Louisiana
ACC Pediatric Reasearch Site Number : 8400023
Haughton
Velocity Clinical Research Site Number : 8400025
Metairie
LSUHSC-Shreveport Site Number : 8400120
Shreveport
Maryland
University of Maryland at The Pediatric Center of Frederick Site Number : 8400004
Frederick
Virgo-Carter Pediatrics Site Number : 8400041
Silver Spring
Missouri
Craig Spiegel, MD Site Number : 8400037
Bridgeton
Mississippi
MedPharmics Biloxi Site Number : 8400080
Biloxi
North Carolina
Blue Pediatric & Adolescent Medicine Group Site Number : 8400100
Boone
Nebraska
Creighton University Site Number : 8400039
Omaha
New York
Tiga Pediatrics Site Number : 8400137
New York
Ohio
Ohio Pediatric Research Site Number : 8400084
Dayton
PriMed Clinical Research Site Number : 8400002
Dayton
Oregon
Cyn3rgy Research Site Number : 8400085
Gresham
Pennsylvania
Allegheny Health and Wellness Pavilion Site Number : 8400047
Erie
South Carolina
Coastal Pediatric Research Charleston Site Number : 8400005
Charleston
Tribe Clinical Research Site Number : 8400110
Greenville
Parkside Pediatrics - Simpsonville Site Number : 8400113
Simpsonville
Tennessee
Pediatric Clinical Trials Tullahoma Site Number : 8400033
Tullahoma
Texas
ARC Clinical Research at Wilson Parke Site Number : 8400059
Austin
Oak Cliff Research Company, LLC Site Number : 8400065
Dallas
Helios Clinical research Site Number : 8400075
Fort Worth
University of North Texas Site Number : 8400079
Fort Worth
University of Texas Medical Board Site Number : 8400067
Galveston
Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400114
Houston
Helios Clinical Research Site Number : 8400109
Houston
FMC SCIENCE Site Number : 8400053
Lampasas
Tekton Research Site Number : 8400128
San Antonio
Tekton Research, Inc Site Number : 8400049
San Antonio
Utah
Ericksen Research and Development Site Number : 8400016
Clinton
Wee Care Pediatrics Site Number : 8400035
Kaysville
Tanner Clinic Site Number : 8400018
Layton
Pediatric Care Site Number : 8400056
Provo
Wee Care Pediatrics Roy Site Number : 8400029
Roy
Copperview Medical Center Site Number : 8400038
South Jordan
Alliance for Multispecialty Research Syracuse Site Number : 8400036
Syracuse
Wee Care Pediatrics Syracuse Site Number : 8400024
Syracuse
West Virginia
Marshall Health Site Number : 8400062
Huntington
Other Locations
Puerto Rico
Investigational Site Number : 6300116
Caguas
Investigational Site Number : 6300122
Guayama
Investigational Site Number : 6300015
San Juan
Investigational Site Number : 6300117
San Juan
Investigational Site Number : 6300140
San Juan
Time Frame
Start Date: 2018-04-25
Completion Date: 2023-09-22
Participants
Target number of participants: 2627
Treatments
Experimental: Group 1a
MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
Experimental: Group 1b
MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age
Active_comparator: Group 2a
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
Active_comparator: Group 2b
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
Sponsors
Leads: Sanofi Pasteur, a Sanofi Company

This content was sourced from clinicaltrials.gov

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