Phase I Clinical Trial of a Candidate PCV13 in Healthy People (NCT05602480) | Clinical Trial Compass
UnknownPhase 1
Phase I Clinical Trial of a Candidate PCV13 in Healthy People
China264 participantsStarted 2022-11-01
Plain-language summary
Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world.
This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.
Who can participate
Age range6 Weeks
SexALL
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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 Ā°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 ā¦
What they're measuring
1
Safety in terms of adverse reactions
Timeframe: within 30 minutes post each vaccination