Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Completed · Phase 3 · NCT03691610
Conditions: Healthy Volunteers (Meningococcal Infection)
At a glance
- Research payments reported, 2025
- $54,618
- U.S. investigators named
- 12
- Sites paid
- 10
- Planned or actual enrollment
- 950
About the trial
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Tested
- 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)
- Dates
- Started 2018-10-04; completion 2023-10-20
- Results posted
- Yes
The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age. The secondary objectives of the study are: * To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routin…
From ClinicalTrials.gov, last updated 2024-06-25. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi Pasteur Inc. reported $54,618 in research payments for this study in 2025 (55 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Teena L. Hughes, M.D. Pediatrics · Tampa, FL
- Lilia Roque-guerrero, MD Pediatrics · Miami, FL
- Wendy C. Daly, MD Pediatrics · Louisville, KY
- Jeffrey L. Wampler, MD Pediatrics · Louisville, KY
- Pamela L. Taylor, DO Pediatrics · Wilmington, NC
- Paul D. Bernhardson, M.D. Pediatrics · Lincoln, NE
- Kimberly M. White, MD, MS Pediatrics · Lincoln, NE
- Rogelio V. Amisola, MD Pediatrics · Beavercreek, OH
- Frank A. Calcagno, MD Pediatrics · Gresham, OR
- Jeffrey Quinones, MD, MBA Pediatrics · Guayama, PR
- Carol Linebarger, M.D. Family Medicine · Austin, TX
- Mahalakshmi Ramchandra, M.D. Pediatrics · Dickinson, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Biomedical Research,llc $31,200
- Primed Clinical Research Llc $11,313
- Clinical Research Puerto Rico,inc $2,500
- Bluegrass Clinical Research,inc $2,400
- Tekton Research Fredericksburg Road $2,105
- Physicians Administrative Solutions Llc $1,500
- Innovo Research Inc $1,500
- Mercury Clinical Research $1,500
- Cyn3rgy Research $500
- Midwest Childrens Health Research Institute $100
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.