Actively Recruiting
A Multi-center, Randomized, Double-blind, Active-controlled Phase 3 Study of Minhai's PCV13-DT/TT Vaccine Compared to Pfizer's PCV13 Vaccine with Hexavalent Vaccine in Healthy Indonesian Infants at 2, 4, and 12-15 Months
Led by Beijing Minhai Biotechnology Co., Ltd · Updated on 2025-03-24
500
Participants Needed
3
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying healthy infants in Indonesia to compare the immune response and safety of two vaccines: Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT, also called Pneuminvac) and Pfizer's 13-valent Pneumococcal Conjugate Vaccine (PCV13, known as Prevenar 13). The study focuses on infants aged 6 to 8 weeks and aims to show that Pneuminvac produces immune responses that are not worse than Prevenar 13 after a booster dose, while also monitoring vaccine safety when given together with a hexavalent vaccine. About 500 infants will be randomly assigned to two groups: one receiving Pneuminvac and the other receiving Prevenar 13. Both vaccines will be given at 2, 4, and 12 to 15 months of age. Additionally, all infants will receive the hexavalent vaccine at 2, 3, and 4 months of age. This design follows World Health Organization recommendations for infant vaccination schedules. Participants will attend scheduled visits for vaccinations and assessments, including blood tests to measure immune responses one month after the booster dose. Safety will be closely tracked by recording any side effects after each vaccine dose and serious adverse events up to six months after the booster. The study aims to evaluate the percentage of infants with protective antibody levels and compare immune responses between vaccines, with total participation lasting from enrollment until several months after the final vaccine dose.
CONDITIONS
Brief Title
A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT/TT Vaccine As Compared to Pfizer's PCV13 Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy infants based on medical history and clinical assessment
- Infants aged between 6 and 8 weeks at enrollment
- Body weight at enrollment at least 3.0 kg
- Axillary temperature below 37.5�b0C within 3 days before first vaccination
- Parent or legal guardian able and willing to provide voluntary written/thumb-printed informed consent
- Parent or legal guardian willing and able to comply with study visits, vaccination plan, and procedures
- Infant's mother has negative HIV, HBV, and syphilis test results within 1 year prior to screening
- Parent or legal guardian has a stable residence and telephone contact in the study area
You will not qualify if you...
- Use of any investigational product other than the study vaccine before or during the trial
- History of Streptococcus pneumoniae infection confirmed by lab testing if available
- Infants who are in care, preterm (born before 37 weeks), or low birth weight (below 2.5 kg)
- History of allergic disease or serious reaction to any vaccine or hypersensitivity to vaccine components
- History of anaphylactic shock
- Abnormal vital signs as judged by investigator
- Acute illness or use of antipyretic, analgesic, or anti-allergic drugs within 3 days before vaccination
- Vaccination with attenuated vaccines within 14 days or inactivated vaccines within 7 days before first dose
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis, or Streptococcus pneumoniae except first dose before 2 months
- History of certain infectious diseases including diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b, Neisseria meningitidis
- Treatment with radiotherapy or immunosuppressive therapy including systemic corticosteroids at specified doses
- Administration of immunoglobulins or blood products within 28 days before vaccination or during study
- History of blood disorders affecting coagulation or anemia
- History of suspected primary immunodeficiency
- History of meningitis, seizures, or neurological disorders
- Family history of congenital or hereditary immunodeficiency
- Infant is a direct descendant of study staff or personnel
- Any medical or social condition that may interfere with study participation or safety
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 - From 2 months to 12-15 months of age
Participants receive study or control PCV13 vaccines at 2, 4, and 12 to 15 months of age, alongside routine hexavalent vaccinations at 2, 3, and 4 months of age.
3 vaccination visits
Duration - 6 months after the booster dose
Participants are monitored for safety and immune response following the booster vaccination.
Visits as scheduled during follow-up period
Trial Site Locations
Total: 3 locations
1
Faculty of Medicine Udayana University
Denpasar, Bali, Indonesia, 80114
Not Yet Recruiting
2
Universitas Padjadjaran Bandung
Bandung, Bandung, Indonesia, 40161
Not Yet Recruiting
3
Faculty of Medicine, padjadjaran University
Bandung, Bandung, Indonesia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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