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Completed Phase 3 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT03691610

Public ClinicalTrials.gov record NCT03691610. 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 24, 2026, 12:45 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

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Study identification

NCT ID
NCT03691610
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Industry
Enrollment
950 participants

Conditions and interventions

Interventions

  • Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine Biological
  • Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine Biological
  • Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine Biological
  • Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine Biological
  • Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine Biological
  • Haemophilus b Conjugate Vaccine Biological
  • Pneumococcal 13-valent Conjugate Vaccine Biological
  • Rotavirus Vaccine, Live, Oral, Pentavalent Biological
  • Hepatitis B Vaccine Biological
  • Measles, Mumps, and Rubella Virus Vaccine Live Biological
  • Varicella Virus Vaccine Live Biological

Biological

Eligibility (public fields only)

Age range
6 Months to 19 Months
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
Oct 3, 2018
Primary completion
Oct 19, 2023
Completion
Oct 19, 2023
Last update posted
Jun 24, 2024

2018 – 2023

United States locations

U.S. sites
45
U.S. states
23
U.S. cities
40
Facility City State ZIP Site status
Alabama Clinical Therapeutics Site Number : 8400036 Birmingham Alabama 35205
Southeastern Pediatric Associates Site Number : 8400009 Dothan Alabama 36305
MedPharmics, LLC - Phoenix Site Number : 8400013 Phoenix Arizona 85015
Emmaus Research Center, Inc Site Number : 8400019 Anaheim California 92804
Coast Clinical Trials, LLC Site Number : 8400073 Bellflower California 90706
Matrix Clinical Research Site Number : 8400082 Gardena California 90247
Madera Family Med Group Site Number : 8400065 Madera California 93637
Next Phase Research Alliance Site Number : 8400044 Homestead Florida 33030
PAS Research Site Number : 8400101 Land O' Lakes Florida 34639
Axcess Medical Research Site Number : 8400021 Loxahatchee Groves Florida 33470
Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400046 Miami Florida 33144
Biomedical Research LLC Site Number : 8400041 Miami Florida 33186
Crystal Biomedical Research Site Number : 8400034 Miami Lakes Florida 33014
PAS Research Site Number : 8400059 Tampa Florida 33613
Omega Pediatrics Site Number : 8400093 Roswell Georgia 30076
Snake River Research, PLLC Site Number : 8400058 Idaho Falls Idaho 83404
Eagle Clinical Research Site Number : 8400094 Chicago Illinois 60621
Brownsboro Park Pediatrics Site Number : 8400039 Louisville Kentucky 40207
All Children Pediatrics Site Number : 8400024 Louisville Kentucky 40243
Meridian Clinical Research, LLC Site Number : 8400035 Baton Rouge Louisiana 70806
Velocity Clinical Research Site Number : 8400016 Metairie Louisiana 70006
Willis-Knighton Physician Network Site Number : 8400075 Shreveport Louisiana 71105
Victory Clinical Research Site Number : 8400026 Baltimore Maryland 21209
Pediatric Associates of Fall River Site Number : 8400112 Fall River Massachusetts 02721
Craig Spiegel, MD Site Number : 8400023 Bridgeton Missouri 63044
Meridian Clinical Research Site Number : 8400097 Hastings Nebraska 68901
Midwest Childrens Health Research Institute Site Number : 8400111 Lincoln Nebraska 68504
Midwest Childrens Health Research Institute Site Number : 8400117 Lincoln Nebraska 68505
MedPharmics Inc Site Number : 8400006 Albuquerque New Mexico 87102
Advantage Clinical Trials Site Number : 8400069 New York New York 10468
Wilmington Health Site Number : 8400054 Wilmington North Carolina 28405
Ohio Pediatric Research Site Number : 8400022 Dayton Ohio 45414
PriMed Clinical Research Site Number : 8400008 Dayton Ohio 45419
Oklahoma State University - Center for Health Sciences Site Number : 8400110 Tulsa Oklahoma 74127
Cyn3rgy Research Site Number : 8400010 Gresham Oregon 97030
Allegheny Health and Wellness Pavilion Site Number : 8400025 Erie Pennsylvania 16505
Kid's Way Pediatrics Site Number : 8400015 Hermitage Pennsylvania 16148
Coastal Pediatric Research Charleston Site Number : 8400002 Charleston South Carolina 29414
Coastal Pediatric Research Charleston Site Number : 8400011 Charleston South Carolina 29414
Tribe Clinical Research Site Number : 8400118 Greenville South Carolina 29607
Pediatric Clinical Trials Tullahoma Site Number : 8400106 Tullahoma Tennessee 37388
Tekton Research Site Number : 8400047 Beaumont Texas 77706
Mercury Clinical Research, Inc. Site Number : 8400088 Dickinson Texas 77539
Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400037 Houston Texas 77074-2085
Tekton Research, Inc. Site Number : 8400040 San Antonio Texas 78240

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 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03691610, 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 Jun 24, 2024 · Synced Jul 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03691610 live on ClinicalTrials.gov.

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