ClinicalTrials.gov record
Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
ClinicalTrials.gov ID: NCT06824194
Public ClinicalTrials.gov record NCT06824194. 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
A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2 Arm Study to Investigate the Safety of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days). The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given as per local recommendations. There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.
Study identification
- NCT ID
- NCT06824194
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,360 participants
Conditions and interventions
Conditions
Interventions
- PCV21 vaccine Biological
- Prevnar 20 vaccine Biological
- M-M-R II vaccine Biological
- Rotarix Biological
- RotaTeq Biological
- Vaxelis vaccine Biological
- Varivax Biological
- Priorix Biological
- VAQTA Biological
- Havrix 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
- Feb 18, 2025 (Actual)
- Primary completion
- Oct 22, 2027 (Estimated)
- Completion
- Oct 22, 2027 (Estimated)
- Last update posted
- Apr 13, 2026
2025 – 2027
United States locations
- U.S. sites
- 103
- U.S. states
- 29
- U.S. cities
- 84
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013 | Birmingham | Alabama | 35205 | — |
| University of Alabama at Birmingham- Site Number : 8400130 | Birmingham | Alabama | 35233 | — |
| Lakeview Clinical Research- Site Number : 8400054 | Guntersville | Alabama | 35976 | — |
| Midway Medical Clinic- Site Number : 8400091 | Oneonta | Alabama | 35121 | — |
| Noble Clinical Research- Site Number : 8400121 | Tucson | Arizona | 85704 | — |
| The Children's Clinic- Site Number : 8400079 | Jonesboro | Arkansas | 72401 | — |
| Helios CR, Inc. - Little Rock- Site Number : 8400090 | Sherwood | Arkansas | 72120 | — |
| Helping Hands Healthcare Group - Fullerton- Site Number : 8400063 | Fullerton | California | 92831 | — |
| Advanced Investigative Medicine- Site Number : 8400055 | Hawthorne | California | 90250 | — |
| Century Research Institute- Site Number : 8400118 | Huntington Park | California | 90255 | — |
| Matrix Clinical Research - Huntington Park- Site Number : 8400117 | Huntington Park | California | 90255 | — |
| Matrix Clinical Research - Los Angeles- Site Number : 8400026 | Los Angeles | California | 90057 | — |
| Matrix Clinical Research - Los Angeles- Site Number : 8400123 | Los Angeles | California | 90057 | — |
| Alliance Research Institute - Lynwood- Site Number : 8400099 | Lynwood | California | 90262 | — |
| Madera Family Medical Group- Site Number : 8400011 | Madera | California | 93637 | — |
| FOMAT-Golden Valley Health Centers- Site Number : 8400084 | Merced | California | 95340 | — |
| Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400072 | Palo Alto | California | 94304 | — |
| Center for Clinical Trials - Paramount- Site Number : 8400100 | Paramount | California | 90723 | — |
| Integrated Clinical Research LLC- Site Number : 8400027 | Sherman Oaks | California | 91356-4173 | — |
| Emanate Health - Queen of the Valley Hospital- Site Number : 8400105 | West Covina | California | 91790 | — |
| All In One Clinic- Site Number : 8400127 | Whittier | California | 90601 | — |
| Amicis Research Center-Winnetka- Site Number : 8400128 | Winnetka | California | 91306 | — |
| Emerson Clinical Research Institute - Washington - Connecticut Avenue- Site Number : 8400102 | Washington D.C. | District of Columbia | 20009 | — |
| D&H Doral Research Center- Site Number : 8400095 | Doral | Florida | 33122 | — |
| Dolphin Medical Research, LLC- Site Number : 8400120 | Doral | Florida | 33172 | — |
| Nextlevel Research Center- Site Number : 8400065 | Doral | Florida | 33172 | — |
| CuraCare- Site Number : 8400125 | Kendall | Florida | 33176 | — |
| PAS RESEARCH-Lutz- Site Number : 8400103 | Lutz | Florida | 33549 | — |
| Abba Medical Research- Site Number : 8400064 | Miami | Florida | 33176 | — |
| D&H National Research Center- Site Number : 8400085 | North Miami | Florida | 33169 | — |
| Alfa Medical Research LLC- Site Number : 8400111 | Pembroke Pines | Florida | 33029 | — |
| PAS Research - Tampa- Site Number : 8400113 | Tampa | Florida | 33613 | — |
| Morehouse School of Medicine - Atlanta- Site Number : 8400093 | Atlanta | Georgia | 30310 | — |
| CenExel - iResearch - Savannah- Site Number : 8400057 | Savannah | Georgia | 31405 | — |
| Bingham Memorial Hospital - Blackfoot- Site Number : 8400114 | Blackfoot | Idaho | 83221 | — |
| Elite Clinical Trials - Blackfoot- Site Number : 8400017 | Blackfoot | Idaho | 83221 | — |
| Clinical Research Prime- Site Number : 8400022 | Idaho Falls | Idaho | 83404 | — |
| Eagle Clinical Research- Site Number : 8400087 | Chicago | Illinois | 60621 | — |
| University of Chicago Medical Center- Site Number : 8400062 | Chicago | Illinois | 60637 | — |
| MidValley Research - Moline- Site Number : 8400096 | Moline | Illinois | 61265 | — |
| South Bend Clinic - Main Campus- Site Number : 8400023 | South Bend | Indiana | 46617 | — |
| Integrated Clinical Trial Services- Site Number : 8400059 | West Des Moines | Iowa | 50265 | — |
| Kentucky Pediatric Research- Site Number : 8400014 | Bardstown | Kentucky | 40004 | — |
| University of Kentucky Chandler Medical Center- Site Number : 8400034 | Lexington | Kentucky | 40536 | — |
| Novak Center For Children's Health- Site Number : 8400073 | Louisville | Kentucky | 40202 | — |
| Bluegrass Clinical Research - Louisville - Blankenbaker Parkway- Site Number : 8400056 | Louisville | Kentucky | 40243 | — |
| Velocity Clinical Research - Lafayette- Site Number : 8400046 | Lafayette | Louisiana | 70508 | — |
| NOLA Research Works- Site Number : 8400035 | New Orleans | Louisiana | 70125 | — |
| The Pediatric Center- Site Number : 8400075 | Columbia | Maryland | 21045 | — |
| The Pediatric Center of Frederick- Site Number : 8400074 | Frederick | Maryland | 21702 | — |
| Virgo Carter Pediatrics- Site Number : 8400001 | Silver Spring | Maryland | 20910 | — |
| Michigan Institute of Research- Site Number : 8400131 | Allen Park | Michigan | 48101 | — |
| Vida Clinical Studies - Dearborn- Site Number : 8400094 | Dearborn | Michigan | 48124 | — |
| Clinical Research Institute - Minneapolis- Site Number : 8400002 | Minneapolis | Minnesota | 55402 | — |
| Jefferson City Medical Group- Site Number : 8400129 | Jefferson City | Missouri | 65109 | — |
| Midwest Children's Health Research Institute - Lincoln - Salt Creek Circle- Site Number : 8400019 | Lincoln | Nebraska | 68504 | — |
| Midwest Children's Health Research Institute- Site Number : 8400016 | Lincoln | Nebraska | 68505 | — |
| Be Well Clinical Studies - Lincoln- Site Number : 8400031 | Lincoln | Nebraska | 68516 | — |
| Midwest Childrens Health Research Institute- Site Number : 8400021 | Lincoln | Nebraska | 68516 | — |
| Midwest Children's Health Research Institute - Lincoln - West A Street- Site Number : 8400045 | Lincoln | Nebraska | 68522 | — |
| PAS Research - Henderson- Site Number : 8400033 | Henderson | Nevada | 89014 | — |
| SUNY Downstate Medical Center- Site Number : 8400039 | Brooklyn | New York | 11203 | — |
| Child Health Care Associates - East Syracuse- Site Number : 8400005 | East Syracuse | New York | 13057 | — |
| GRO Clinical- Site Number : 8400109 | Hyde Park | New York | 12538 | — |
| SUNY Upstate Medical University - Syracuse- Site Number : 8400115 | Syracuse | New York | 13210 | — |
| PAS Research-Bronx- Site Number : 8400104 | The Bronx | New York | 10460 | — |
| Advantage Clinical Trials- Site Number : 8400030 | The Bronx | New York | 10468 | — |
| Atrium Health - Myers Park- Site Number : 8400080 | Charlotte | North Carolina | 28207 | — |
| Atrium Health - STRIVE Vaccine Research Clinic- Site Number : 8400060 | Charlotte | North Carolina | 28207 | — |
| Haywood Pediatric and Adolescent Medicine Group- Site Number : 8400051 | Clyde | North Carolina | 28721 | — |
| East Carolina University- Site Number : 8400061 | Greenville | North Carolina | 27858 | — |
| Piedmont Healthcare - Family Medicine- Site Number : 8400077 | Statesville | North Carolina | 28625 | — |
| Legacy Clinical Trials Oklahoma City- Site Number : 8400097 | Oklahoma City | Oklahoma | 73103 | — |
| Cyn3rgy Research- Site Number : 8400029 | Gresham | Oregon | 97030 | — |
| Kid's Way Pediatrics- Site Number : 8400119 | Hermitage | Pennsylvania | 16148 | — |
| Pas Research - Pittsburgh- Site Number : 8400050 | Pittsburgh | Pennsylvania | 15227 | — |
| Neighbors Pediatrics- Site Number : 8400068 | Charleston | South Carolina | 29407 | — |
| Tribe Clinical Research - Simpsonville- Site Number : 8400069 | Simpsonville | South Carolina | 29680 | — |
| Parkside Pediatrics - Simpsonville- Site Number : 8400078 | Simpsonville | South Carolina | 29681 | — |
| Tribe Clinical Research - Spartanburg- Site Number : 8400083 | Spartanburg | South Carolina | 29301 | — |
| Austin Regional Clinic - ARC Four Points- Site Number : 8400082 | Austin | Texas | 78726 | — |
| Cedar Health Research - Dallas- Site Number : 8400092 | Dallas | Texas | 75251 | — |
| PAS Research - Children's Care Clinic- Site Number : 8400012 | Edinburg | Texas | 78539 | — |
| The University of Texas Health Science Center- Site Number : 8400024 | Houston | Texas | 77030 | — |
| Biopharma Informatic - Houston - Business Center Drive- Site Number : 8400108 | Houston | Texas | 77043 | — |
| Mercury Clinical Research - Houston - Savoy Drive- Site Number : 8400049 | Houston | Texas | 77070 | — |
| Pediatric Associates - Houston- Site Number : 8400101 | Houston | Texas | 77087 | — |
| Pioneer Research Solutions - Houston - Stancliff Road- Site Number : 8400126 | Houston | Texas | 77099 | — |
| GLRI - McAllen Research- Site Number : 8400098 | Pharr | Texas | 78577 | — |
| AIM Trials- Site Number : 8400052 | Plano | Texas | 75093 | — |
| Pediatric Center - Richmond- Site Number : 8400122 | Richmond | Texas | 77469 | — |
| North Houston Internal Medicine & Pediatric Clinic- Site Number : 8400018 | Tomball | Texas | 77375 | — |
| Wee Care Pediatrics - Kaysville- Site Number : 8400028 | Kaysville | Utah | 84037 | — |
| Wee Care Pediatrics - Layton- Site Number : 8400044 | Layton | Utah | 84041 | — |
| Rio Clinical Trials - Canyon View- Site Number : 8400132 | Ogden | Utah | 84404 | — |
| Utah Valley Pediatrics - Orem- Site Number : 8400053 | Orem | Utah | 84057 | — |
| Ogden Clinic - Mountain View - CCT Research- Site Number : 8400032 | Pleasant View | Utah | 84404 | — |
| Pediatric Care - Provo- Site Number : 8400041 | Provo | Utah | 84604 | — |
| Wee Care Pediatrics - Roy- Site Number : 8400070 | Roy | Utah | 84067 | — |
| J. Lewis Research - Foothill Family Clinic - Salt Lake City- Site Number : 8400058 | Salt Lake City | Utah | 84109 | — |
| Wee Care Pediatrics - Syracuse- Site Number : 8400066 | Syracuse | Utah | 84075 | — |
| National Clinical Research- Site Number : 8400010 | Richmond | Virginia | 23294 | — |
| Full Circle Family Medicine- Site Number : 8400110 | Germantown | Wisconsin | 53022 | — |
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 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06824194, 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 Apr 13, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06824194 live on ClinicalTrials.gov.