What is Minhai's PCV13-DT/TT vaccine studying for pneumococcal infections?

Minhai's PCV13-DT/TT vaccine is being studied to compare its immune response and safety with Pfizer's PCV13 vaccine in healthy infants. Researchers want to see if it produces similar protective antibodies when given with the hexavalent vaccine. The study is sponsored by Beijing Minhai Biotechnology Co., Ltd and helps understand how well Pneuminvac works for young infants.

Who may be eligible for this pneumococcal vaccine clinical trial?

Healthy infants aged 6 to 8 weeks may be eligible to participate. They must weigh at least 3.0 kg, have no serious allergies or history of severe reactions to vaccines, and have mothers with negative HIV, HBV, and syphilis tests. The trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this pneumococcal vaccine clinical trial?

Study-related care, including the study vaccines and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants can expect to receive vaccines and health evaluations without charge.

Actively Recruiting

Phase 3

Age: 6Weeks - 8Weeks

All Genders

Healthy Volunteers

ID06608199

Phase 3 Study Comparing Minhais PCV13-DTTT Vaccine to Pfizers PCV13 Vaccine in Healthy Indonesian Infants Receiving Hexavalent Vaccine at 2, 4, and 12-15 Months of Age

Led by Beijing Minhai Biotechnology Co., Ltd · Updated on 2025-03-24

500

Participants Needed

Research Sites

69 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying healthy infants in Indonesia to compare the immune response and safety of two vaccines Minhais 13-valent Pneumococcal Polysaccharide Conjugate Vaccine PCV13-DTTT, also called Pneuminvac and Pfizers 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

Age: 6Weeks - 8Weeks

All Genders

Healthy Volunteers

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

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Phase 3 Study Comparing Minhais PCV13-DTTT Vaccine to Pfizers PCV13 Vaccine in Healthy Indonesian Infants Receiving Hexavalent Vaccine at 2, 4, and 12-15 Months of Age

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria