Phase I Clinical Trial of a Candidate PCV13 in Healthy People
Pneumococcal Infections
About this trial
This is an interventional prevention trial for Pneumococcal Infections focused on measuring Pneumonia, Pneumococcal
Eligibility Criteria
Inclusion Criteria: Satisfy the age requirements of the clinical trial; willing to provide proof of identity; Subjects or guardians must provide informed consent forms with personal signature and date; Male and female of childbearing age should agree to take effective contraception measures; Subjects or guardians can obey the requirements of the clinical study; Axillary temperature below 37.3 °C. Exclusion Criteria: Laboratory indicators (expect those have no clinical significance) out of normal ranges required; Received any pneumococcal vaccine; Allergic history to any drugs, vaccine or vaccine-related component; Infants with congenital malformations, developmental disorders, genetic defects, or severe malnutrition; Infants diagnosed with pathological jaundice that lasts for 2~4 weeks and occurs repeatedly; Breast-feeding or pregnant women, or positive U-HCG; High blood pressure uncontrolled by medication; Known or suspected immune deficiency or immune suppression; Serious congenital malformation, history of organ resection or serious chronic illness; Received blood products or intravenous immunoglobulin (except Hepatitis B immunoglobulin); History of clinic-proven or serology-proven infectious disease especially caused by streptococcus pneumoniae; History of convulsions, epilepsy or encephalopathy or a family history of mental illness; A vaccination-related contraindications that other investigator believes; Plans to participate in or is participating in any other clinical study; Any other factors judged by investigator that may interfere subject's compliance with the protocol.
Sites / Locations
- Xiangtan Maternal and Child Health HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Experimental
Active Comparator
1A
2A
3A
4A
5A
6A
6B
6C
7A
7B
Subjects received one dose of PCV13 at 18 years of age and above.
Subjects received one dose of PCV13 at 6~17 years of age.
Subjects received one dose of PCV13 at 2~5 years of age.
Subjects received two doses of PCV13 at 12~23 months of age.
Subjects received three doses of PCV13 at 7~11 months of age.
Subjects received four doses of PCV13 at 3 months of age.
Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old).
Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old).
Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old).
Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old).