Active immunization against invasive disease caused by Streptococcus pneumoniae serotypes contained in the vaccine
Conditions
Interventions
Adult Cohort (Cohort 1) - Trial Group:PCV21 vaccine, single dose
Adult Cohort (Cohort 1) - Control Group:PPSV23 vaccine, single dose
Pediatric Cohort (Cohort 2) - Trial Group:PCV21 vaccine, single dose
Pediatric Cohort (Cohort 2) - Control Group:13vPCV vaccine, single dose
Infant Cohort (Cohort 3) - Trial Group:PCV21 vaccine, two doses with a 56-day interval
Infant Cohort (Cohort 3) - Control Group:13vPCV vaccine, two doses with a 56-day interval
Baby Cohort (Cohort 4) - Trial Group:PCV21 vaccine, three doses with a 28-day interval between dose 1 and 2, and at least a 56-day interval between dose 2 and 3
Baby Cohort (Cohort 4) - Control Group:13vPCV vaccine, three doses with a 28-day interval between dose 1 and 2, and at least a 56-day interval between dose 2 and 3
Baby Cohort (Cohort 5) - Trial Group:PCV21 vaccine, four doses administered at 2, 4, 6, and 12 months of age
Baby Cohort (Cohort 5) - Control Group:13vPCV vaccine, four doses administered at 2, 4, 6, and 12 months of age
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
0.1 Years to 42 Years
Inclusion criteria
Inclusion criteria: 1. Age (1) Applicable only to adults (Cohort 1) I01: Age 18-49 years on the day of enrollment (2) Applicable only to children (Cohort 2) I02: Age 2-5 years on the day of enrollment (3) Applicable only to toddlers (Cohort 3) I03: Age 12-23 months on the day of enrollment (4) Applicable only to infants (Cohort 4) I04: Age 7-11 months on the day of enrollment (5) Applicable only to infants (Cohort 5) I05: Age 2 months (42-89 days) on the day of enrollment (6) Notes: "18-49 years" refers to the period from the 18th birthday to the day before the 50th birthday. "2-5 years" refers to the period from the 2nd birthday to the day before the 6th birthday. "12-23 months" refers to the period from the 1st birthday to the day before the 2nd birthday. "7-11 months" refers to the period from the 7th month after birth to the day before the 1st birthday. "42-89 days" refers to the period from day 42 after birth to the day before day 90 after birth. 2. Subject Type and Disease Characteristics (1) I06: Determined to be healthy subjects through medical assessment (including medical history and physical examination) (2) Applicable to toddlers (Cohort 3) and infants (Cohorts 4 and 5) I07: Born at full-term gestation (>=37 weeks) with birth weight >=2.5 kg 3. Sexual Activity, Contraception/Barrier Methods, and Pregnancy Testing Requirements (1) Applicable only to adults (Cohort 1) I08: Female subjects who are not pregnant or breastfeeding and meet one of the following criteria are eligible to participate in the study: 1) Non-childbearing potential. Females must have been postmenopausal for at least 1 year or have undergone sterilization surgery to be considered non-childbearing potential. Or 2) Childbearing potential and agree to use effective contraception or abstain from sexual intercourse for at least 4 weeks before and at least 4 weeks after administration of the study intervention. Note: For female subjects of childbearing potential, a highly sensitive pregnancy test (urine or serum pregnancy test as required by local regulations) must be negative prior to administration of the first dose of study intervention. 4. Informed Consent (1) Applicable only to adults (Cohort 1) I09: Informed consent form has been signed and dated (2) Applicable only to children (Cohort 2), toddlers (Cohort 3), and infants (Cohorts 4 and 5) I10: Parent(s) or other legally authorized representative(s) (LAR) (and an independent witness if required by local regulations) have signed and dated the informed consent form 5. Other Inclusion Criteria (1) Applicable only to adults (Cohort 1) I11: Able to attend all scheduled visits and comply with all study procedures (2) Applicable only to children (Cohort 2), toddlers (Cohort 3), and infants (Cohorts 4 and 5) I12: The subject and their parent(s)/legally authorized representative(s) are able to attend all scheduled visits and comply with all study procedures
Exclusion criteria
Exclusion criteria: 1. Disease Status (1) All Cohorts 1) Known or suspected congenital or acquired immunodeficiency; receiving immunosuppressive therapy (e.g., anticancer chemotherapy or radiation); or long-term systemic corticosteroid therapy. 2) History of microbiologically confirmed pneumococcal infection. 3) History of seizures; or clinically significant stable or progressive neurological disorders (e.g., inflammatory neurological diseases, encephalopathy, cerebral palsy). 4) Known systemic hypersensitivity to any component of the study intervention; or a life-threatening reaction to the study intervention or products containing identical components. 5) Laboratory-confirmed thrombocytopenia; or reported contraindication to intramuscular injection due to known thrombocytopenia. 6) Bleeding disorder contraindicating intramuscular injection, or anticoagulant therapy, within 3 weeks prior to enrollment. 7) Chronic disease stage that, in the investigator's opinion, may interfere with study conduct or completion. 8) Moderate or severe acute illness/infection (per investigator judgment) or febrile illness on the day of vaccination (temperature >=37.3°C for age >14 years; >=37.5°C for age <=14 years). Enrollment permitted only after recovery or resolution of fever. 9) Prior receipt of any investigational or licensed vaccine for prevention of pneumococcal disease. (2) Adults Only (Cohort 1) Alcohol, prescription drug, or illicit drug abuse deemed by the investigator as potentially interfering with study conduct or completion. (3) Adults (Cohort 1) and Children (Cohort 2) Only 1) Receipt of any vaccine within 4 weeks prior to study intervention, or planned receipt. 2) Receipt of immunoglobulin, blood transfusion, or blood products within the past 3 months. (4) Toddlers (Cohort 3) and Infants (Cohorts 4 and 5) Only 1) Receipt of any injectable live attenuated vaccine within 14 days before or planned within 14 days after study intervention; receipt of any inactivated vaccine or oral live attenuated vaccine within 8 days before or planned within 8 days after study intervention. 2) Receipt of immunoglobulin, blood, or blood products since birth. 2. Previous/Current Clinical Study Experience Participation in, or planned participation during the current study period in, another clinical study involving vaccines, drugs, medical devices, or medical procedures at the time of enrollment (or within 6 weeks prior to the first study intervention). 3. Other Exclusion Criteria (1) Adults Only (Cohort 1) 1) Biological or adopted children of the investigator or personnel directly involved in this study. 2) Individuals restricted in freedom by administrative or court order, or those in emergency care or involuntary hospitalization. (2) Children (Cohort 2), Toddlers (Cohort 3), and Infants (Cohorts 4 and 5) Only 1) Investigators, employees of the study center directly involved in the planned study, or their immediate family members (i.e., parents, spouses, biological or adopted children). 2) Individuals restricted in freedom by administrative or court order, or those in emergency care. 3) Planned receipt of any vaccine within 4 weeks after administration of the study intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants experiencing unsolicited immediate AEs;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;Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs);Presence and intensity of abnormal blood and urine test results in Cohort 1 and Cohort 2; | — |
Countries
China
Contacts
Public ContactPan Hongxing
Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Outcome results
None listed