PCV21 vaccine: Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Prevnar 20 vaccine: Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
M-M-R II vaccine: Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
RotaTeq: Pharmaceutical form:Solution-Route of administration:Oral
Vaxelis vaccine: Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Varivax: Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Hexaxim Vaccine: Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Sun City Clinical Research- Site Number : 8400247 | Glendale | Arizona | |
| Eclipse Clinical Research- Site Number : 8400029 | Tucson | Arizona | |
| Northwest Arkansas Pediatric Clinic- Site Number : 8400030 | Fayetteville | Arkansas | |
| Southland Clinical Research Center- Site Number : 8400243 | Fountain Valley | California | |
| Century Research Institute- Site Number : 8400065 | Huntington Park | California | |
| Matrix Clinical Research - Huntington Park- Site Number : 8400012 | Huntington Park | California | |
| Matrix Clinical Research - Los Angeles- Site Number : 8400013 | Los Angeles | California | |
| University of California Los Angeles Medical Center- Site Number : 8400238 | Los Angeles | California | |
| Pasadena Clinical Trials - Pasadena - North Madison Avenue- Site Number : 8400259 | Pasadena | California | |
| FOMAT Medical Research - Pediatric, Infant & Adolescence Medicine- Site Number : 8400063 | Ventura | California | |
| Velocity Clinical Research - Washington DC- Site Number : 8400049 | Washington D.C. | District of Columbia | |
| PAS Research- Site Number : 8400123 | Clearwater | Florida | |
| Prohealth Research Center- Site Number : 8400159 | Doral | Florida | |
| NurtureGen Research- Site Number : 8400205 | Homestead | Florida | |
| EMDA Clinical Research- Site Number : 8400237 | Miami | Florida | |
| Dade Research Center- Site Number : 8400007 | Miami | Florida | |
| Acevedo Clinical Research Associates- Site Number : 8400089 | Miami | Florida | |
| Miami Clinical Research Tower- Site Number : 8400189 | Miami | Florida | |
| Vasconcello-Cohen MD Research, LLC- Site Number : 8400248 | Miami | Florida | |
| Bio-Medical Research- Site Number : 8400147 | Miami | Florida | |
| High Quality Research- Site Number : 8400245 | Miami | Florida | |
| Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400032 | Miami Lakes | Florida | |
| BioResearch Partner (BRP) - Premium Healthcare Medical Center - Miami Lakes- Site Number : 8400203 | Miami Lakes | Florida | |
| Optimal Research Sites- Site Number : 8400232 | Orange City | Florida | |
| SEC Clinical Research - Pensacola- Site Number : 8400003 | Pensacola | Florida | |
| National Clinical Trials - Tampa- Site Number : 8400229 | Tampa | Florida | |
| PAS Research - Tampa- Site Number : 8400002 | Tampa | Florida | |
| Medical Research Partners - Ammon- Site Number : 8400239 | Ammon | Idaho | |
| Bingham Memorial Hospital - Blackfoot- Site Number : 8400084 | Blackfoot | Idaho | |
| Leavitt Women's Healthcare- Site Number : 8400085 | Idaho Falls | Idaho | |
| Snake River Research- Site Number : 8400060 | Idaho Falls | Idaho | |
| Clinical Research Prime Rexburg- Site Number : 8400250 | Rexburg | Idaho | |
| Alliance for Multispeciality Research - El Dorado- Site Number : 8400010 | El Dorado | Kansas | |
| Hutchinson Clinic- Site Number : 8400061 | Hutchinson | Kansas | |
| Cotton O'Neil Pediatrics- Site Number : 8400009 | Topeka | Kansas | |
| KUR Research at Columbia MD - 6220 Old Dobbin Lane- Site Number : 8400242 | Columbia | Maryland | |
| Michigan Institute of Research- Site Number : 8400207 | Allen Park | Michigan | |
| University of Missouri Hospital- Site Number : 8400244 | Columbia | Missouri | |
| Vector Clinical Trials- Site Number : 8400249 | Las Vegas | Nevada | |
| Hawthorne- Bienstar Lindenwold- Site Number : 8400256 | Lindenwold | New Jersey |
+ 72 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06736041 on ClinicalTrials.gov ↗ ← All trials in Australia