Phase
Condition
N/ATreatment
PCV21 vaccine
VAQTA
Prevnar 20 vaccine
Clinical Study ID
Ages 42-89 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 42 to 89 days on the day of inclusion
Participants who are healthy as determined by medical evaluation including medicalhistory and physical examination
Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or bornafter 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
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; orlong-term systemic corticosteroid therapy
History of microbiologically confirmed Streptococcus pneumoniae infection ordisease.
History of seizure or significant stable or progressive neurologic disorders such asinflammatory nervous system diseases, encephalopathy, cerebral palsy
Known systemic hypersensitivity to any of the study interventions components, orhistory of a life-threatening reaction to the study interventions used in the studyor to a product containing any of the same substances
Thrombocytopenia, or known thrombocytopenia, as reported by the parent/legalacceptable representative (LAR), 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 itmight interfere with study conduct or completion
Moderate or severe acute illness/infection (according to investigator judgment) orfebrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study interventionadministration. A prospective participant should not be included in the study untilthe condition has resolved or the febrile event has subsided.
Previous vaccination against Streptococcus pneumoniae
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 firststudy intervention administration) or planned participation during the present studyperiod in another clinical study investigating a vaccine, drug, medical device, ormedical procedure
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Study Design
Connect with a study center
Investigational Site Number : 1520002
Santiago, Reg Metropolitana De Santiago 8380418
ChileActive - Recruiting
Investigational Site Number : 1520001
Santiago, 8880465
ChileActive - Recruiting
Investigational Site Number : 1520003
Santiago, 8330034
ChileActive - Recruiting
Velocity Clinical Research - Sioux City- Site Number : 8400007
Sioux City, Iowa 51106
United StatesActive - Recruiting
Michael W. Simon, M.D., PSC- Site Number : 8400001
Lexington, Kentucky 40517
United StatesActive - Recruiting
Velocity Clinical Research - New Orleans- Site Number : 8400006
New Orleans, Louisiana 70119
United StatesActive - Recruiting
~SUNY Upstate Medical University- Site Number : 8400015
Syracuse, New York 13210
United StatesActive - Recruiting
Kid's Way Pediatrics- Site Number : 8400013
Hermitage, Pennsylvania 16148
United StatesActive - Recruiting
Kool Kids Pediatrics- Site Number : 8400012
Houston, Texas 77065
United StatesActive - Recruiting
University of Texas Medical Branch at Galveston- Site Number : 8400005
League City, Texas 77555
United StatesActive - Recruiting
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