Phase I Clinical Trial of PCV24 in Children Aged 2 Months (Minimum 6 Weeks) to 17 Years (NCT06675032) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Phase I Clinical Trial of PCV24 in Children Aged 2 Months (Minimum 6 Weeks) to 17 Years
China230 participantsStarted 2024-04-27
Plain-language summary
Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in children aged 2 Months (Minimum 6 Weeks) to 17 Years . The objective of the study is to evaluate the safety tolerability and immunogenicity of PCV24. The trial is a randomized, blind, controlled combined placebo and positive vaccine control I clinical trial.
Who can participate
Age range
6 Weeks – 17 Years
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:
* Healthy subjects aged 2\~3 months (minimum 6 weeks old) and 7 months old\~17 years old, and the guardian of the subject can provide valid identification of the subject and the guardian of the subject.
* Subjects and/or their guardians voluntarily consent to the subjects to participate in this study and sign the informed consent form.
* Subjects and/or their guardians have the ability to understand (non-illiterate) study procedures.
* Female subjects and male subjects of childbearing age agree to use effective contraceptive measures within 6 months from the start of the study to the date of immunization.
* Those who have completed the full course of primary immunization in accordance with the requirements of this clinical trial, and the age before the booster immunization is 12\~15 months old, (the interval between the booster immunization time and the last dose of primary immunization is at least 2 months).
* In the opinion of the investigator, the subject's guardian can comply with all the requirements of this clinical trial protocol during the booster phase of the subject.
Exclusion Criteria:
* Individuals who have previously received any type of pneumococcal vaccine or have a history of invasive disease caused by Streptococcus pneumoniae (confirmed by clinical, serological, or microbiological methods).
* Abnormal results from physical examinations or laboratory tests that are deemed clinically significant by a clinician.
* Individuals suspected or …
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
2 months ~17 years old incidence of adverse events AE
Timeframe: At the 30 day after every dose vaccination