Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Public ClinicalTrials.gov record NCT06736041. 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 and Immunogenicity 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 measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccine (Prevnar 20, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines 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 20-valent pneumococcal vaccines) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given at the same timepoints. 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
- NCT06736041
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,714 participants
Conditions and interventions
Conditions
Interventions
- PCV21 vaccine Biological
- Prevnar 20 vaccine Biological
- M-M-R II vaccine Biological
- RotaTeq Biological
- Vaxelis vaccine Biological
- Varivax Biological
- Hexaxim Vaccine 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
- Dec 18, 2024 (Actual)
- Primary completion
- May 17, 2027 (Estimated)
- Completion
- May 17, 2027 (Estimated)
- Last update posted
- Apr 22, 2026
2024 – 2027
United States locations
- U.S. sites
- 66
- U.S. states
- 22
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sun City Clinical Research- Site Number : 8400247 | Glendale | Arizona | 85304 | — |
| Eclipse Clinical Research- Site Number : 8400029 | Tucson | Arizona | 85745 | — |
| Northwest Arkansas Pediatric Clinic- Site Number : 8400030 | Fayetteville | Arkansas | 72703 | — |
| Southland Clinical Research Center- Site Number : 8400243 | Fountain Valley | California | 92708 | — |
| Century Research Institute- Site Number : 8400065 | Huntington Park | California | 90255 | — |
| Matrix Clinical Research - Huntington Park- Site Number : 8400012 | Huntington Park | California | 90255 | — |
| Matrix Clinical Research - Los Angeles- Site Number : 8400013 | Los Angeles | California | 90057 | — |
| University of California Los Angeles Medical Center- Site Number : 8400238 | Los Angeles | California | 90095 | — |
| Pasadena Clinical Trials - Pasadena - North Madison Avenue- Site Number : 8400259 | Pasadena | California | 91101 | — |
| FOMAT Medical Research - Pediatric, Infant & Adolescence Medicine- Site Number : 8400063 | Ventura | California | 93003 | — |
| Velocity Clinical Research - Washington DC- Site Number : 8400049 | Washington D.C. | District of Columbia | 20016 | — |
| PAS Research- Site Number : 8400123 | Clearwater | Florida | 33756 | — |
| Prohealth Research Center- Site Number : 8400159 | Doral | Florida | 33166 | — |
| NurtureGen Research- Site Number : 8400205 | Homestead | Florida | 33030 | — |
| EMDA Clinical Research- Site Number : 8400237 | Miami | Florida | 33126 | — |
| Dade Research Center- Site Number : 8400007 | Miami | Florida | 33135 | — |
| Acevedo Clinical Research Associates- Site Number : 8400089 | Miami | Florida | 33142 | — |
| Miami Clinical Research Tower- Site Number : 8400189 | Miami | Florida | 33155 | — |
| Vasconcello-Cohen MD Research, LLC- Site Number : 8400248 | Miami | Florida | 33183 | — |
| Bio-Medical Research- Site Number : 8400147 | Miami | Florida | 33184 | — |
| High Quality Research- Site Number : 8400245 | Miami | Florida | 33184 | — |
| Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400032 | Miami Lakes | Florida | 33014 | — |
| BioResearch Partner (BRP) - Premium Healthcare Medical Center - Miami Lakes- Site Number : 8400203 | Miami Lakes | Florida | 33016 | — |
| Optimal Research Sites- Site Number : 8400232 | Orange City | Florida | 32763 | — |
| SEC Clinical Research - Pensacola- Site Number : 8400003 | Pensacola | Florida | 32501 | — |
| National Clinical Trials - Tampa- Site Number : 8400229 | Tampa | Florida | 33612 | — |
| PAS Research - Tampa- Site Number : 8400002 | Tampa | Florida | 33613 | — |
| Medical Research Partners - Ammon- Site Number : 8400239 | Ammon | Idaho | 83406 | — |
| Bingham Memorial Hospital - Blackfoot- Site Number : 8400084 | Blackfoot | Idaho | 83221 | — |
| Leavitt Women's Healthcare- Site Number : 8400085 | Idaho Falls | Idaho | 83404 | — |
| Snake River Research- Site Number : 8400060 | Idaho Falls | Idaho | 83404 | — |
| Clinical Research Prime Rexburg- Site Number : 8400250 | Rexburg | Idaho | 83440 | — |
| Alliance for Multispeciality Research - El Dorado- Site Number : 8400010 | El Dorado | Kansas | 67042 | — |
| Hutchinson Clinic- Site Number : 8400061 | Hutchinson | Kansas | 67502 | — |
| Cotton O'Neil Pediatrics- Site Number : 8400009 | Topeka | Kansas | 66604 | — |
| KUR Research at Columbia MD - 6220 Old Dobbin Lane- Site Number : 8400242 | Columbia | Maryland | 21045 | — |
| Michigan Institute of Research- Site Number : 8400207 | Allen Park | Michigan | 48101 | — |
| University of Missouri Hospital- Site Number : 8400244 | Columbia | Missouri | 65212 | — |
| Vector Clinical Trials- Site Number : 8400249 | Las Vegas | Nevada | 89128 | — |
| Hawthorne- Bienstar Lindenwold- Site Number : 8400256 | Lindenwold | New Jersey | 08021 | — |
| University of New Mexico Health Sciences Center- Site Number : 8400240 | Albuquerque | New Mexico | 87131-0001 | — |
| Hawthorne Health - Staten Island- Site Number : 8400254 | Staten Island | New York | 10309 | — |
| Prime Global Research- Site Number : 8400246 | The Bronx | New York | 10456 | — |
| Monroe Biomedical Research - Monroe- Site Number : 8400225 | Monroe | North Carolina | 28112 | — |
| Dayton Clinical Research- Site Number : 8400087 | Dayton | Ohio | 45409 | — |
| Oklahoma State University Center for Health Sciences- Site Number : 8400121 | Tulsa | Oklahoma | 74107 | — |
| Allegheny Health Network - Health and Wellness Pavilion- Site Number : 8400111 | Erie | Pennsylvania | 16506 | — |
| Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400005 | Greenville | South Carolina | 29607 | — |
| Coastal Carolina Research Center - North Charleston- Site Number : 8400064 | North Charleston | South Carolina | 29405 | — |
| Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400112 | Baytown | Texas | 77521 | — |
| South Texas Clinical Research- Site Number : 8400025 | Corpus Christi | Texas | 78413 | — |
| FamilyHealthWatch - KeyPoint Clinical Research- Site Number : 8400173 | Dallas | Texas | 75237 | — |
| Helios Clinical Research - Fort Worth - 8th Avenue- Site Number : 8400072 | Fort Worth | Texas | 76104 | — |
| Ventavia Research Group - Houston - North Loop West- Site Number : 8400093 | Houston | Texas | 77008 | — |
| Gonzalez Family & Occupational Medicine- Site Number : 8400035 | Houston | Texas | 77029 | — |
| Private Practice - Dr. Chinyere N. Awa- Site Number : 8400252 | Houston | Texas | 77057 | — |
| La Providence Pediatrics & Family Clinics- Site Number : 8400026 | Houston | Texas | 77071 | — |
| Houston Clinical Research Associates- Site Number : 8400018 | Houston | Texas | 77090 | — |
| Biopharma Informatic - Katy - Katy Freeway- Site Number : 8400258 | Katy | Texas | 77450 | — |
| Maximos Ob/Gyn- Site Number : 8400056 | League City | Texas | 77573 | — |
| Pediatric Center - Richmond- Site Number : 8400068 | Richmond | Texas | 77469 | — |
| LinQ Research, LLC - Rosharon- Site Number : 8400257 | Rosharon | Texas | 77583 | — |
| Tanner Clinic - Layton Antelope A- Site Number : 8400241 | Layton | Utah | 84041 | — |
| Wasatch Pedicatrics- Site Number : 8400153 | Murray | Utah | 84107 | — |
| Rio Clinical Trials - Canyon View- Site Number : 8400222 | Ogden | Utah | 84404 | — |
| Clinical Research Partners - Richmond - Forest Avenue- Site Number : 8400236 | Richmond | Virginia | 23220 | — |
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 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06736041, 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 22, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06736041 live on ClinicalTrials.gov.