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Completed Phase 3 Interventional Accepts healthy volunteers Results available

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

ClinicalTrials.gov ID: NCT03537508

Public ClinicalTrials.gov record NCT03537508. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 9:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT03537508
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Industry
Enrollment
2,627 participants

Conditions and interventions

Interventions

  • MenACYW conjugate vaccine Biological
  • MenACYW-135 conjugate vaccine Biological
  • DTaP-IPV//Hib vaccine Biological
  • Pneumococcal 13-valent conjugate vaccine Biological
  • Pentavalent rotavirus vaccine Biological
  • Hepatitis B vaccine Biological
  • Measles, mumps, rubella (MMR) vaccine Biological
  • Varicella vaccine Biological
  • Hepatitis A vaccine Biological

Biological

Eligibility (public fields only)

Age range
42 Days to 89 Days
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 24, 2018
Primary completion
Sep 21, 2023
Completion
Sep 21, 2023
Last update posted
Oct 14, 2024

2018 – 2023

United States locations

U.S. sites
65
U.S. states
24
U.S. cities
57
Facility City State ZIP Site status
Birmingham Pediatric Associates Site Number : 8400026 Birmingham Alabama 35205
Southeastern Pediatric Associates Site Number : 8400003 Dothan Alabama 36305
MedPharmics, LLC - Phoenix Site Number : 8400083 Phoenix Arizona 85015
Northwest Arkansas Pediatric Clinic Site Number : 8400011 Fayetteville Arkansas 72703
The Children's Clinic of Jonesboro, PA Site Number : 8400032 Jonesboro Arkansas 72401
Emmaus Research Center, Inc Site Number : 8400031 Anaheim California 92804
Premier Health Research Center Site Number : 8400007 Downey California 90241
Joint Clinical Trials Huntington Park Site Number : 8400126 Huntington Park California 90255
United Clinical Research Site Number : 8400092 Huntington Park California 90255
Matrix Clinical Research Site Number : 8400095 Los Angeles California 90057
Center for Clinical Trials, LLC Site Number : 8400030 Paramount California 90723
Center for Clinical Trials of San Gabriel Site Number : 8400076 West Covina California 91790
Asclepes Research Centers Site Number : 8400064 Brooksville Florida 34613
Avail Clinical Research Site Number : 8400077 DeLand Florida 32720
Next Phase Research Alliance Site Number : 8400057 Hialeah Florida 33013
Homestead Medical Clinic, P.A. Site Number : 8400014 Homestead Florida 33030
Next Phase Research Alliance Site Number : 8400040 Homestead Florida 33030
Children's Research, LLC Site Number : 8400063 Lake Mary Florida 32746
Axcess Medical Research Site Number : 8400068 Loxahatchee Groves Florida 33470
Acevedo Clinical Research Associates Site Number : 8400001 Miami Florida 33186
Florida Hospital Medical Group Pediatrics Site Number : 8400108 Orlando Florida 32803
IMIC Inc Site Number : 8400022 Palmetto Bay Florida 33157
Jedidiah Clinical Research Site Number : 8400132 Tampa Florida 33617
Baybol Research Institute Site Number : 8400008 Chamblee Georgia 30341
Snake River Research, PLLC Site Number : 8400073 Idaho Falls Idaho 83404
Qualmedica Research, LLC Site Number : 8400106 Evansville Indiana 47715
Brownsboro Park Pediatrics Site Number : 8400010 Louisville Kentucky 40207
All Children Pediatrics Site Number : 8400043 Louisville Kentucky 40243
ACC Pediatric Reasearch Site Number : 8400023 Haughton Louisiana 71037
Velocity Clinical Research Site Number : 8400025 Metairie Louisiana 70006
LSUHSC-Shreveport Site Number : 8400120 Shreveport Louisiana 71103
University of Maryland at The Pediatric Center of Frederick Site Number : 8400004 Frederick Maryland 21702
Virgo-Carter Pediatrics Site Number : 8400041 Silver Spring Maryland 20910
MedPharmics Biloxi Site Number : 8400080 Biloxi Mississippi 39531
Craig Spiegel, MD Site Number : 8400037 Bridgeton Missouri 63044
Creighton University Site Number : 8400039 Omaha Nebraska 68131
Tiga Pediatrics Site Number : 8400137 New York New York 10467
Blue Pediatric & Adolescent Medicine Group Site Number : 8400100 Boone North Carolina 28607
Ohio Pediatric Research Site Number : 8400084 Dayton Ohio 45414
PriMed Clinical Research Site Number : 8400002 Dayton Ohio 454429
Cyn3rgy Research Site Number : 8400085 Gresham Oregon 97030
Allegheny Health and Wellness Pavilion Site Number : 8400047 Erie Pennsylvania 16505
Coastal Pediatric Research Charleston Site Number : 8400005 Charleston South Carolina 29414
Tribe Clinical Research Site Number : 8400110 Greenville South Carolina 29607
Parkside Pediatrics - Simpsonville Site Number : 8400113 Simpsonville South Carolina 29681
Pediatric Clinical Trials Tullahoma Site Number : 8400033 Tullahoma Tennessee 37388
ARC Clinical Research at Wilson Parke Site Number : 8400059 Austin Texas 78726
Oak Cliff Research Company, LLC Site Number : 8400065 Dallas Texas 75218
Helios Clinical research Site Number : 8400075 Fort Worth Texas 76104
University of North Texas Site Number : 8400079 Fort Worth Texas 76107-2699
University of Texas Medical Board Site Number : 8400067 Galveston Texas 77555-0163
Helios Clinical Research Site Number : 8400109 Houston Texas 77008
Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400114 Houston Texas 77074-2085
FMC SCIENCE Site Number : 8400053 Lampasas Texas 76550
Tekton Research, Inc Site Number : 8400049 San Antonio Texas 78229
Tekton Research Site Number : 8400128 San Antonio Texas 78244
Ericksen Research and Development Site Number : 8400016 Clinton Utah 84015
Wee Care Pediatrics Site Number : 8400035 Kaysville Utah 84037
Tanner Clinic Site Number : 8400018 Layton Utah 84041
Pediatric Care Site Number : 8400056 Provo Utah 84064
Wee Care Pediatrics Roy Site Number : 8400029 Roy Utah 84067
Copperview Medical Center Site Number : 8400038 South Jordan Utah 84095
Wee Care Pediatrics Syracuse Site Number : 8400024 Syracuse Utah 84075-9143
Alliance for Multispecialty Research Syracuse Site Number : 8400036 Syracuse Utah 84075-9645
Marshall Health Site Number : 8400062 Huntington West Virginia 25701

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03537508, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 14, 2024 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03537508 live on ClinicalTrials.gov.

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