Actively Recruiting
A Phase III, Observer-blind, Randomized Controlled Trial to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)
Led by CanSino Biologics Inc. · Updated on 2026-02-27
600
Participants Needed
3
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the immune response, safety, and antibody function of a new 13-valent pneumococcal conjugate vaccine compared to a control vaccine in healthy infants in Thailand. This Phase 3 randomized, observer-blind, active-controlled trial involves infants aged at least 6 weeks to 2 months who receive vaccinations following a 2+1 schedule at 2 months, 4 months, and 12-15 months. The study aims to better understand how well the experimental vaccine stimulates immunity and its safety in this young population. Participants are randomly assigned to receive either the experimental PCV13i vaccine or the control Prevnar 13 vaccine, both given as intramuscular injections of 0.5 ml. Each infant receives three doses: the primary doses at 2 and 4 months of age, followed by a booster dose between 12 to 15 months. Some infants will be part of subgroups undergoing additional immune response tests after the primary series and before the booster. Throughout the study, infants will be closely monitored for any side effects for 7 days after each vaccination and for any other adverse events for 30 days. Immune responses will be measured before vaccination, after the primary doses, and following the booster dose. Serious adverse events will be tracked for up to 16 to 19 months. Parents or guardians will be contacted regularly, and infants will be assessed for antibody levels and safety outcomes during this period.
CONDITIONS
Brief 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy infants aged 2 months (42-90 days) at screening, eligible from 6 weeks of age
- Parent or legal guardian able and willing to provide informed consent
- Ability of participant and guardian to comply with all trial procedures and follow-up
- Parent or guardian has stable residence in study area and reliable telephone contact
You will not qualify if you...
- Infants born before 35 weeks of gestation
- Prior receipt of any pneumococcal vaccine
- Current or recent participation in another interventional clinical trial
- Axillary temperature 47.86C at enrollment (visit rescheduled after recovery)
- Congenital abnormalities, chronic conditions, genetic disorders, severe malnutrition, or inherited diseases affecting study outcomes
- History of anaphylactic shock or serious allergic reaction to vaccines
- History of epilepsy or convulsions
- Received immunosuppressive, cytotoxic, or systemic steroid treatment over 2 weeks (with exceptions)
- Received or planned blood/plasma products or immunoglobulins during study
- History of coagulation disorders or blood conditions causing anemia or bleeding
- Known or suspected immunodeficiency
- Vaccination with other vaccines within 7 days prior to enrollment
- Conditions or therapies that could interfere with study participation or outcomes
- Direct descendant of study staff or sponsor employees
- Other conditions posing additional risks or interfering with the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 13 months
Participants receive three doses of vaccine: the first dose at 2 months of age, the second dose at 2 months plus an interval (exact timing not specified), and a booster dose at 12 to 15 months of age.
3 vaccination visits (in-person), including the booster dose
Duration - Up to 16 to 19 months from first vaccination
Participants are monitored for immunogenicity and safety after vaccination, including adverse events and antibody levels up to an average of 16 to 19 months.
Multiple follow-up visits for safety and immunogenicity assessments
Trial Site Locations
Total: 3 locations
1
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand
Actively Recruiting
2
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Actively Recruiting
3
Phramongkutklao Hospital
Bangkok, Thailand
Actively Recruiting
Research Team
M
Meixu Yan
L
Lina Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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