Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Public ClinicalTrials.gov record NCT06397768. 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
Phase III, Randomized, Single-blind, Placebo-controlled, Multi-center Study to Evaluate Non-interference of Concomitant Administration of Routine Pediatric Vaccines on the Antibody Response of an Investigational Live-attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Infants and Toddlers (CORAL)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12 months of age (Cohort 2). The primary objective of the study will be to assess non-inferiority of the RSV infant and toddler (RSVt) vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine \[Vaxelis® or Pentacel® and Recombivax HB®\] Prevnar 20®, and RotaTeq®), and 12 months of age (M-M-R II, VARIVAX, and Prevnar 20 or per local country recommendations) compared to when administered non-concomitantly.
Study identification
- NCT ID
- NCT06397768
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,226 participants
Conditions and interventions
Conditions
Interventions
- RSVt vaccine Biological
- Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine Biological
- Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine Biological
- Hepatitis B vaccine Biological
- Streptococcus pneumoniae vaccine Biological
- Rotavirus vaccine Biological
- Measles, mumps, and rubella vaccine Biological
- Varicella virus vaccine Biological
- Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 6 Months to 12 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
- May 13, 2024 (Actual)
- Primary completion
- Sep 18, 2025 (Actual)
- Completion
- Sep 18, 2025 (Actual)
- Last update posted
- Oct 5, 2026
2024 – 2025
United States locations
- U.S. sites
- 66
- U.S. states
- 22
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400007 | Birmingham | Alabama | 35205 | — |
| South Alabama Medical Clinic- Site Number : 8400065 | Grand Bay | Alabama | 36541 | — |
| MedPharmics - Mobile - Dauphin Street- Site Number : 8400017 | Mobile | Alabama | 36608 | — |
| Northwest Arkansas Pediatric Clinic- Site Number : 8400002 | Fayetteville | Arkansas | 72703 | — |
| Alliance Research Institute - Bell Gardens - Garfield Avenue- Site Number : 8400040 | Bell Gardens | California | 90201 | — |
| Matrix Clinical Research - Huntington Park- Site Number : 8400018 | Huntington Park | California | 90255 | — |
| Paradigm Clinical Research Centers- Site Number : 8400059 | La Mesa | California | 91942 | — |
| Matrix Clinical Research - Los Angeles- Site Number : 8400008 | Los Angeles | California | 90057 | — |
| Kaiser Permanente - Oakland Medical Center- Site Number : 8400047 | Oakland | California | 94611 | — |
| Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400070 | Palo Alto | California | 94304 | — |
| Kaiser Permanente - Sierra Gardens- Site Number : 8400063 | Roseville | California | 95661 | — |
| Kaiser Permanente - Point West Medical Offices- Site Number : 8400064 | Sacramento | California | 95815 | — |
| Kaiser Permanente - San Jose Medical Center- Site Number : 8400060 | San Jose | California | 95119 | — |
| Kaiser Permanente - Santa Clara Medical Center- Site Number : 8400061 | Santa Clara | California | 95051 | — |
| Integrated Clinical Research LLC- Site Number : 8400036 | Sherman Oaks | California | 91356-4173 | — |
| Kaiser Permanente - Walnut Creek Medical Center- Site Number : 8400062 | Walnut Creek | California | 94596 | — |
| Velocity Clinical Research - Washington DC- Site Number : 8400050 | Washington D.C. | District of Columbia | 20016 | — |
| Prohealth Research Center- Site Number : 8400068 | Doral | Florida | 33166 | — |
| The Medici Medical Research- Site Number : 8400055 | Hollywood | Florida | 33021 | — |
| Dade Research Center- Site Number : 8400014 | Miami | Florida | 33126 | — |
| Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400015 | Miami Lakes | Florida | 33014 | — |
| SEC Clinical Research - Pensacola- Site Number : 8400034 | Pensacola | Florida | 32501 | — |
| PAS Research- Site Number : 8400005 | Tampa | Florida | 33613 | — |
| Leavitt Women's Healthcare- Site Number : 8400009 | Idaho Falls | Idaho | 83404 | — |
| Velocity Clinical Research - Sioux City- Site Number : 8400054 | Sioux City | Iowa | 51106 | — |
| Alliance for Multispeciality Research - El Dorado- Site Number : 8400019 | El Dorado | Kansas | 67042 | — |
| University of Kentucky Chandler Medical Center- Site Number : 8400051 | Lexington | Kentucky | 40536 | — |
| Velocity Clinical Research - New Orleans- Site Number : 8400058 | New Orleans | Louisiana | 70119 | — |
| Research Works INC- Site Number : 8400044 | New Orleans | Louisiana | 70125 | — |
| Velocity Clinical Research - Gulfport- Site Number : 8400011 | Gulfport | Mississippi | 39503 | — |
| QPS Bio-Kinetic Clinical Applications- Site Number : 8400046 | Springfield | Missouri | 65802 | — |
| Boeson Research - Great Falls- Site Number : 8400041 | Great Falls | Montana | 59405 | — |
| Boeson Research - Missoula- Site Number : 8400006 | Missoula | Montana | 59804 | — |
| Velocity Clinical Research - Grand Island- Site Number : 8400016 | Grand Island | Nebraska | 68803 | — |
| Midwest Childrens Health Research Institute- Site Number : 8400038 | Lincoln | Nebraska | 68516 | — |
| Velocity Clinical Research - Omaha- Site Number : 8400001 | Omaha | Nebraska | 68134 | — |
| PAS Research - Henderson- Site Number : 8400049 | Henderson | Nevada | 89014 | — |
| NYU Langone Cardiothoracic Surgery Associates - Garden City- Site Number : 8400048 | Garden City | New York | 11530 | — |
| Summerwood Pediatrics- Site Number : 8400021 | Liverpool | New York | 13088 | — |
| SUNY Upstate Medical University - Syracuse- Site Number : 8400029 | Syracuse | New York | 13210 | — |
| Dayton Clinical Research- Site Number : 8400030 | Dayton | Ohio | 45409 | — |
| Ohio Pediatrics - Dayton- Site Number : 8400033 | Dayton | Ohio | 45414 | — |
| Senders Pediatrics- Site Number : 8400022 | South Euclid | Ohio | 44121 | — |
| Cyn3rgy Research- Site Number : 8400053 | Gresham | Oregon | 97030 | — |
| Square-1 Clinical Research- Site Number : 8400031 | Erie | Pennsylvania | 16506 | — |
| Pas Research - Pittsburgh- Site Number : 8400043 | Pittsburgh | Pennsylvania | 15227 | — |
| Neighbors Pediatrics- Site Number : 8400072 | Charleston | South Carolina | 29407 | — |
| Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400012 | Greenville | South Carolina | 29607 | — |
| South Texas Clinical Research- Site Number : 8400004 | Corpus Christi | Texas | 78413 | — |
| Javara - Privia Medical Group North Texas - Dallas- Site Number : 8400003 | Dallas | Texas | 75230 | — |
| PAS Research - Children's Care Clinic- Site Number : 8400035 | Edinburg | Texas | 78539 | — |
| Helios Clinical Research - Fort Worth - 8th Avenue- Site Number : 8400020 | Fort Worth | Texas | 76104 | — |
| Ventavia Research Group - Houston - North Loop West- Site Number : 8400010 | Houston | Texas | 77008 | — |
| The University of Texas Health Science Center- Site Number : 8400037 | Houston | Texas | 77030 | — |
| DM Clinical Research - Houston - Jones Road- Site Number : 8400052 | Houston | Texas | 77065 | — |
| Mercury Clinical Research - Houston - Savoy Drive- Site Number : 8400045 | Houston | Texas | 77070 | — |
| La Providence Pediatrics & Family Clinics- Site Number : 8400039 | Houston | Texas | 77071 | — |
| Houston Clinical Research Associates- Site Number : 8400013 | Houston | Texas | 77090 | — |
| University of Texas Medical Branch at Galveston- Site Number : 8400057 | League City | Texas | 77555 | — |
| Maximos Ob/Gyn- Site Number : 8400024 | League City | Texas | 77573 | — |
| Research Your Health- Site Number : 8400066 | Plano | Texas | 75093 | — |
| Pediatric Center - Richmond- Site Number : 8400032 | Richmond | Texas | 77469 | — |
| North Houston Internal Medicine & Pediatric Clinic- Site Number : 8400025 | Tomball | Texas | 77375 | — |
| Utah Valley Pediatrics - Orem- Site Number : 8400067 | Orem | Utah | 84057 | — |
| Ogden Clinic - Mountain View - CCT Research- Site Number : 8400056 | Pleasant View | Utah | 84404 | — |
| Wee Care Pediatrics - Roy- Site Number : 8400071 | Roy | Utah | 84067 | — |
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 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06397768, 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 5, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06397768 live on ClinicalTrials.gov.