A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT/TT Vaccine As Comp… (NCT06608199) | Clinical Trial Compass
RecruitingPhase 3
A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT/TT Vaccine As Compared to Pfizer's PCV13 Vaccine
Indonesia500 participantsStarted 2024-11-01
Plain-language summary
The goal of this clinical trial is to evaluate the immunogenicity and safety of Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT) as compared to Pfizer's 13-valent Pneumococcal Conjugate Vaccine (PCV13) when co-administered with Hexavalent Vaccines at 2,4, and 12-15 months of age, to healthy infants in Indonesia. This study aims to demonstrate the non-inferiority of the serotype-specific immune responses elicited by the novel PCV13-DT/TT (Pneuminvac) as compared to PCV13(Prevenar 13) one month after the booster dose, and evaluate the safety of PCV13 co-administrated with Hexavalent Vaccine(Hexaxim).
Who can participate
Age range
6 Weeks – 8 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
. Healthy infants based on medical history and clinical assessment.
. Infants age of 6-8 weeks at enrolment. Infants will be eligible since the day they reach 6 weeks of age and until 8 weeks of age included.
. \*Body weight at enrollment ≥3.0 kg (If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.).
. \*On the day of vaccination and within 3 days prior to 1st dose of vaccination, axillary temperatures \<37.5°C/99.1°F (If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.).
. Infant's parent(s) or legal guardian must be able and willing to provide voluntary written/thumb-printed informed consent for the infant to participate in the study.
. Infant's parent(s) or legal guardian must be willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
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
Immugenocity
Timeframe: 1. Percentage of participants with serotype-specific IgG concentrations ≥ 0.35 μg/mL, measured 30 days after the booster dose of the investigational vaccine. 2. GMC ratio of serotype-specific IgG responses 30 days after the booster dose of the investigat
. The infant's mother must provide related medical certificate(s) for the negative results for HIV, HBV and syphilis infection within 1 year prior to screening.
. Infant's parent(s) or legal guardian must have a readily identifiable place of residence in the study area, be available for the duration of trial participation, and have a means of telephone contact.
Exclusion criteria
. Use of any investigational product other than that used in the study prior to randomization or planned use of such a product during the period of study participation.
. History of S. pneumoniae infection as confirmed by laboratory testing if available.
. The infant who are children in care, preterm and low-birth-weight (Preterm infants have a gestational age below 37 weeks at birth and low-birth-weight infants have a birth weight below 2.5 kg).
. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the investigational vaccine. And/or all components of the hexavalent vaccine.
. History of anaphylactic shock.
. Any abnormal vital sign as judged by the investigator.
. \*Participant experiences acute diseases or acute exacerbation of chronic diseases or uses antipyretic, analgesic and anti-allergic drugs (such as paracetamol, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days before vaccination.
. \*History of administration of attenuated vaccines within 14 days (\<14 days) and inactivated vaccines within 7 days (\<7 days) prior to the 1st dose of investigational vaccine (If the participant\[s\] does not meet the criteria, the visit may be rescheduled when the criteria are met).