Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Purpose
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.
Condition
- Pneumococcal Immunization
Eligibility
- Eligible Ages
- Between 42 Days and 89 Days
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Aged 42 to 89 days on the day of inclusion - Participants who are healthy as determined by medical evaluation including medical history and physical examination - Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable as assessed by the investigator
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply: - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy - History of microbiologically confirmed Streptococcus pneumoniae infection or disease - Any contraindication to the routine pediatric vaccine being administered in the study - History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy - Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances - Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legal acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion - Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided - Receipt of any non-US Food and Drug Administration (FDA) approved vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any non-US FDA approved vaccine in the 4 weeks following the study intervention administration, including monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations. - Receipt of any Bacillus of Calmette and Guerin (BCG) vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period - Previous vaccination against S. pneumoniae - Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus - Receipt of more than 1 dose of hepatitis B vaccine - Receipt of immune globulins, blood or blood-derived products since birth - Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Modified double-blind - Blinding for vaccine group assignment: participants and participant's parent(s) / legally acceptable representative(s) (LARs), outcome assessors, Investigators, laboratory personnel, and Sponsor study staff - No blinding for vaccine group assignment: those preparing and administering the study interventions
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group 1: PCV21 |
Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA |
|
|
Active Comparator Group 2: 20vPCV |
Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA |
|
Recruiting Locations
Birmingham, Alabama 35205
Birmingham, Alabama 35233
Oneonta, Alabama 35121
Tucson, Arizona 85704
Jonesboro, Arkansas 72401
Sherwood, Arkansas 72120
Fullerton, California 92831
Hawthorne, California 90250
Huntington Park, California 90255
Huntington Park, California 90255
Los Angeles, California 90057
Los Angeles, California 90057
Lynwood, California 90262
Madera, California 93637
Merced, California 95340
Palo Alto, California 94304
Sherman Oaks, California 91356-4173
West Covina, California 91790
Whittier, California 90601
Winnetka, California 91306
Washington D.C., District of Columbia 20009
Doral, Florida 33122
Doral, Florida 33172
Kendall, Florida 33176
Lutz, Florida 33549
North Miami, Florida 33169
Pembroke Pines, Florida 33029
Tampa, Florida 33613
Atlanta, Georgia 30310
Blackfoot, Idaho 83221
Blackfoot, Idaho 83221
Idaho Falls, Idaho 83404
Chicago, Illinois 60621
Chicago, Illinois 60637
Moline, Illinois 61265
South Bend, Indiana 46617
West Des Moines, Iowa 50265
Bardstown, Kentucky 40004
Lexington, Kentucky 40536
Louisville, Kentucky 40202
Louisville, Kentucky 40243
Lafayette, Louisiana 70508
New Orleans, Louisiana 70125
Columbia, Maryland 21045
Frederick, Maryland 21702
Allen Park, Michigan 48101
Jefferson City, Missouri 65109
Lincoln, Nebraska 68504
Lincoln, Nebraska 68505
Lincoln, Nebraska 68516
Lincoln, Nebraska 68522
Henderson, Nevada 89014
Brooklyn, New York 11203
East Syracuse, New York 13057
Hyde Park, New York 12538
The Bronx, New York 10460
The Bronx, New York 10468
Charlotte, North Carolina 28207
Charlotte, North Carolina 28207
Clyde, North Carolina 28721
Greenville, North Carolina 27858
Statesville, North Carolina 28625
Oklahoma City, Oklahoma 73103
Gresham, Oregon 97030
Hermitage, Pennsylvania 16148
Pittsburgh, Pennsylvania 15227
Charleston, South Carolina 29407
Simpsonville, South Carolina 29680
Simpsonville, South Carolina 29681
Spartanburg, South Carolina 29301
Austin, Texas 78726
Dallas, Texas 75251
Edinburg, Texas 78539
Houston, Texas 77030
Houston, Texas 77043
Houston, Texas 77070
Houston, Texas 77087
Houston, Texas 77099
Pharr, Texas 78577
Plano, Texas 75093
Richmond, Texas 77469
Layton, Utah 84041
Ogden, Utah 84404
Pleasant View, Utah 84404
Provo, Utah 84604
Roy, Utah 84067
Salt Lake City, Utah 84109
Syracuse, Utah 84075
Richmond, Virginia 23294
Germantown, Wisconsin 53022
Bayamón, Puerto Rico 00961
Bayamón, Puerto Rico 00961
Guayama, Puerto Rico 00786
Ponce, Puerto Rico 00716
Ponce, Puerto Rico 00717
San Juan, Puerto Rico 00907
San Juan, Puerto Rico 00918
Trujillo Alto, Puerto Rico 00976
More Details
- NCT ID
- NCT06824194
- Status
- Recruiting
- Sponsor
- Sanofi
Study Contact
Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
contact-us@sanofi.com