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Tests treatment safety and results for Pneumococcal Infections
Official title A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)
ClinicalTrials.gov ID: NCT07017777
What this study is testing
What is PCV13i?
PCV13i is an investigational medicine, being studied as a potential treatment for pneumococcal infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 3 randomized, observation-blinded, active-controlled, parallel-group clinical trial designed to evaluate the immunogenicity, safety, and functional antibody response of the experimental vaccine versus the control vaccine in healthy Thailand infants vaccinated at a 2+1 schedule (2 months, 4 months and 12-15 months). The trial will enroll approximately 600 healthy infants aged 2 months (at least 6 weeks) who will be randomly assigned in a 1:1 ratio to receive either the experimental or control vaccine, with 100 in each group (200 in total) randomized to subgroups and subject to additional immunogenicity assessments.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 2. Healthy volunteers may be eligible.
You may be able to join if
- Healthy infants with stable clinical conditions aged 2 months (42-90 days) at the time of screening, based on medical history and clinical assessment...
- Infant's parent or legal guardian must be able and willing to provide informed consent for the infant's participation in the study.
- Participants and their parent or legal guardian must demonstrate the ability to comply with all trial procedures and be available for the entire...
- The infant's parent or legal guardian must have an easily identifiable and stable place of residence within the study area, be available for the...
You likely can't join if
- for the first dose:
- Infants born at \<35 weeks of gestation.
- Infants who have previously received any pneumococcal vaccine.
- Infants currently participating in or who have recently participated in another treatment clinical trial.
- Infants with an axillary temperature of ≥37.8°C at the time of enrollment (the participant must be deferred until recovery. The visit may be...
- Infants with any congenital abnormalities, chronic medical conditions, or genetic disorders, severe malnutrition, inherited disease and others, that...
See the full eligibility criteria
- Healthy infants with stable clinical conditions aged 2 months (42-90 days) at the time of screening, based on medical history and clinical assessment by the investigator. Infants will be eligible starting from the day...
- Infant's parent or legal guardian must be able and willing to provide informed consent for the infant's participation in the study.
- Participants and their parent or legal guardian must demonstrate the ability to comply with all trial procedures and be available for the entire follow-up duration.
- The infant's parent or legal guardian must have an easily identifiable and stable place of residence within the study area, be available for the duration of trial participation, and have access to a reliable means of...
- for the first dose:
- Infants born at \<35 weeks of gestation.
- Infants who have previously received any pneumococcal vaccine.
- Infants currently participating in or who have recently participated in another treatment clinical trial.
- Infants with an axillary temperature of ≥37.8°C at the time of enrollment (the participant must be deferred until recovery. The visit may be rescheduled when this criterion is met.)
- Infants with any congenital abnormalities, chronic medical conditions, or genetic disorders, severe malnutrition, inherited disease and others, that in the investigator's judgment, may interfere with the study outcomes.
- History of anaphylactic shock
- History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the experimental and control vaccine
- History of epilepsy and convulsions.
- Have received immunosuppressive treatment, cytotoxic treatment, systemic steroid treatment for more than 2 weeks, etc. (excluding local treatment, surface treatment of acute non-concurrent dermatitis, or spray treatment...
- Received or planned to receive blood/plasma products or immunoglobulins throughout the study period or prior to study vaccination.
- History of coagulation disorders or blood conditions that could cause anemia or excess bleeding as judged by the investigator.
- Infants with known or suspected immunodeficiency, as determined by medical history and/or physical examination.
- Administration of other vaccines within 7 days prior to enrollment.
- Any history or current evidence of a condition or therapy that could confound study results, interfere with participation, or is not in the best interest of the participant, as judged by the investigator.
- The participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the contract research organization (CRO), the investigator, or study site personnel.
- Any other condition or situation that, in the investigator's judgment, might interfere with the study or pose additional risks to the participant. Individual termination criteria for subsequent doses:
- Severe allergic reaction after the previous vaccination.
- Serious adverse events caused by the previous vaccination that is not suitable for subsequent vaccination(s) as judged by the investigator.
- Newly identified symptoms or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose, or that meet the exclusion criteria for the first dose. The decision to...
- Other reasons for exclusion considered by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 weeks to 2 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.