Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Rotarix: Pharmaceutical form:Solution-Route of administration:Oral
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
Priorix: Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
VAQTA: Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Havrix: Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Study summary
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.
Eligibility
Primary outcome measure(s)
- Presence of any immediate adverse events (AEs) — Within 30 minutes after each vaccination
Number of participants experiencing solicited and unsolicited immediate AEs - Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection — Through 7 days after each vaccine injection
Number of participants experiencing solicited injection site and systemic reactions - Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection — Through 30 days after each vaccine injection
Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs - Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection) — Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Number of participants experiencing SAEs - Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection) — Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Number of participants experiencing AESIs
Trial sites (132)
| Facility | City | Region | Status |
|---|---|---|---|
| Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013 | Birmingham | Alabama | |
| University of Alabama at Birmingham- Site Number : 8400130 | Birmingham | Alabama | |
| Lakeview Clinical Research- Site Number : 8400054 | Guntersville | Alabama | |
| Midway Medical Clinic- Site Number : 8400091 | Oneonta | Alabama | |
| Noble Clinical Research- Site Number : 8400121 | Tucson | Arizona | |
| The Children's Clinic- Site Number : 8400079 | Jonesboro | Arkansas | |
| Helios CR, Inc. - Little Rock- Site Number : 8400090 | Sherwood | Arkansas | |
| Helping Hands Healthcare Group - Fullerton- Site Number : 8400063 | Fullerton | California | |
| Advanced Investigative Medicine- Site Number : 8400055 | Hawthorne | California | |
| Century Research Institute- Site Number : 8400118 | Huntington Park | California | |
| Matrix Clinical Research - Huntington Park- Site Number : 8400117 | Huntington Park | California | |
| Matrix Clinical Research - Los Angeles- Site Number : 8400026 | Los Angeles | California | |
| Matrix Clinical Research - Los Angeles- Site Number : 8400123 | Los Angeles | California | |
| Alliance Research Institute - Lynwood- Site Number : 8400099 | Lynwood | California | |
| Madera Family Medical Group- Site Number : 8400011 | Madera | California | |
| FOMAT-Golden Valley Health Centers- Site Number : 8400084 | Merced | California | |
| Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400072 | Palo Alto | California | |
| Center for Clinical Trials - Paramount- Site Number : 8400100 | Paramount | California | |
| Integrated Clinical Research LLC- Site Number : 8400027 | Sherman Oaks | California | |
| Emanate Health - Queen of the Valley Hospital- Site Number : 8400105 | West Covina | California | |
| All In One Clinic- Site Number : 8400127 | Whittier | California | |
| Amicis Research Center-Winnetka- Site Number : 8400128 | Winnetka | California | |
| Emerson Clinical Research Institute - Washington - Connecticut Avenue- Site Number : 8400102 | Washington D.C. | District of Columbia | |
| D&H Doral Research Center- Site Number : 8400095 | Doral | Florida | |
| Dolphin Medical Research, LLC- Site Number : 8400120 | Doral | Florida | |
| Nextlevel Research Center- Site Number : 8400065 | Doral | Florida | |
| CuraCare- Site Number : 8400125 | Kendall | Florida | |
| PAS RESEARCH-Lutz- Site Number : 8400103 | Lutz | Florida | |
| Abba Medical Research- Site Number : 8400064 | Miami | Florida | |
| D&H National Research Center- Site Number : 8400085 | North Miami | Florida | |
| Alfa Medical Research LLC- Site Number : 8400111 | Pembroke Pines | Florida | |
| PAS Research - Tampa- Site Number : 8400113 | Tampa | Florida | |
| Morehouse School of Medicine - Atlanta- Site Number : 8400093 | Atlanta | Georgia | |
| CenExel - iResearch - Savannah- Site Number : 8400057 | Savannah | Georgia | |
| Bingham Memorial Hospital - Blackfoot- Site Number : 8400114 | Blackfoot | Idaho | |
| Elite Clinical Trials - Blackfoot- Site Number : 8400017 | Blackfoot | Idaho | |
| Clinical Research Prime- Site Number : 8400022 | Idaho Falls | Idaho | |
| Eagle Clinical Research- Site Number : 8400087 | Chicago | Illinois | |
| University of Chicago Medical Center- Site Number : 8400062 | Chicago | Illinois | |
| MidValley Research - Moline- Site Number : 8400096 | Moline | Illinois |
+ 92 more sites — see the full list on the official registry below.
More Sanofi trials in Turkey
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 NCT06824194 on ClinicalTrials.gov ↗ ← All trials in Turkey