Pneumococcal disease caused by Streptococcus pneumoniae
Conditions
Interventions
A:2 doses(1P+1)
B:2 doses(1P+1)
C:3 doses(2P+1)
D:3 doses(2P+1)
E:4 doses(3P+1)
Sponsors
Guangxi Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
0.1 Years to 0.1 Years
Inclusion criteria
Inclusion criteria: 1. Healthy infants are determined through medical history assessment and clinical examination. 2. Infants are to be 2 months old (minimum 6 weeks old) (42-89 days). 3. Birth weight>= 2.5 kg, and at enrollment, infant weight >= 3.5 kg. 4. Guardians must be capable and willing to sign the informed consent form, agreeing to their child’s participation in this study. 5. Guardians must be able to understand and comply with the study requirements and procedures, and be willing and able to participate in follow-ups as specified in the protocol throughout the study. 6. Guardians must have a permanent residence in the study area, ensuring participation throughout the study period, and be reachable by phone or other means. 7. The interval between vaccination on the same day with other subunit vaccines and inactivated vaccines should be >= 7 days, and with other live attenuated vaccines should be >= 14 days. 8. Axillary temperature <=37.3?.
Exclusion criteria
Exclusion criteria: 1. Previously vaccinated with any pneumococcal vaccine. 2. History of laboratory-confirmed invasive pneumococcal infection (if relevant records exist). 3. History of severe vaccine adverse reactions (such as anaphylactic shock, generalized urticaria, laryngeal edema, respiratory distress, etc.) or known allergy to components of the study vaccine. 4. History of being diagnosed with pathological jaundice by a clinician (such as jaundice persisting for more than 14 days after birth, or recurring jaundice after resolution) or accompanied by pathological indications (such as liver function abnormalities, infections, biliary abnormalities, etc.). 5. Premature infants (gestational age < 37 weeks) or history of significant perinatal complications (such as severe birth trauma, asphyxia [Apgar score <=6 at birth, or requiring intubation/continuous ventilation]) or major congenital structural defects. 6. Suspected primary immunodeficiency judged by the physician; if only a family history of immunodeficiency exists, the investigator will decide whether to exclude based on the circumstances. 7. History of epilepsy, meningitis, or other neurological diseases. 8. Have received or plan to receive immunoglobulin (excluding hepatitis B immunoglobulin received at birth for the prevention of hepatitis B), blood products, or systemic immunosuppressive therapy (if used for more than 14 days cumulatively). 9. Known history of severe hematologic diseases (such as congenital coagulopathy, severe anemia diagnosed at birth, etc.). 10. Experienced acute illness or in acute exacerbation of chronic disease in the past 3 days. 11. Used antipyretic analgesics and antihistamines in the past 3 days. 12. The investigator judges that there are other medical or social factors that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum IgG antibody of 13 pneumococcal serotypes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Opsonophagocytic Activity antibodies of 13 pneumococcal serotypes; | — |
Countries
China
Contacts
Public ContactYi Mo
Guangxi Center for Disease Prevention and Control
Outcome results
None listed