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 range
6 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety in terms of adverse reactions
Timeframe: within 30 minutes post each vaccination