Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.
Study identification
- NCT ID
- NCT03691610
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 950 participants
Conditions and interventions
Conditions
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 4, 2018 (Actual)
- Primary completion
- Oct 20, 2023 (Actual)
- Completion
- Oct 20, 2023 (Actual)
- Last update posted
- Jun 25, 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 25, 2024 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03691610 live on ClinicalTrials.gov.