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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,320
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Pharmaceutical form:Solution-Route of administration:Oral
Pharmaceutical form:Solution-Route of administration:Oral
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013
Birmingham, Alabama, United States
RECRUITINGUniversity of Alabama at Birmingham- Site Number : 8400130
Birmingham, Alabama, United States
RECRUITINGLakeview Clinical Research- Site Number : 8400054
Guntersville, Alabama, United States
ACTIVE_NOT_RECRUITINGMidway Medical Clinic- Site Number : 8400091
Oneonta, Alabama, United States
Presence of any immediate adverse events (AEs)
Number of participants experiencing solicited and unsolicited immediate AEs
Time frame: Within 30 minutes after each vaccination
Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
Number of participants experiencing solicited injection site and systemic reactions
Time frame: Through 7 days after each vaccine injection
Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection
Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Time frame: Through 30 days after each vaccine injection
Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)
Number of participants experiencing SAEs
Time frame: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)
Number of participants experiencing AESIs
Time frame: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
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CONTACT
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Noble Clinical Research- Site Number : 8400121
Tucson, Arizona, United States
RECRUITINGThe Children's Clinic- Site Number : 8400079
Jonesboro, Arkansas, United States
RECRUITINGHelios CR, Inc. - Little Rock- Site Number : 8400090
Sherwood, Arkansas, United States
RECRUITINGHelping Hands Healthcare Group - Fullerton- Site Number : 8400063
Fullerton, California, United States
RECRUITINGAdvanced Investigative Medicine- Site Number : 8400055
Hawthorne, California, United States
RECRUITINGMatrix Clinical Research - Los Angeles- Site Number : 8400026
Los Angeles, California, United States
RECRUITING...and 114 more locations