Streptococcus Pneumoniae Infections
Conditions
Keywords
15-valent pneumococcal conjugate vaccine, Diphtheria, Tetanus, Pertussis Vaccine
Brief summary
This clinical study aims to evaluate the mutual influence of combined administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine in the target population
Interventions
BIOLOGICAL15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
Administer 0.5ml of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) separately at different locations upon enrollment. Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Only administer the Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) and according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Sponsors
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 3 Months
Healthy volunteers
Yes
Inclusion criteria
* Infants aged 3 months (90-119 days old), full-term (37-42 weeks pregnant), with a birth weight of ≥ 2.5kg; * The legal guardian provides informed consent and signs the informed consent form; * The legal guardian agrees to comply with the requirements of the clinical research protocol, is willing to accept a follow-up of 10 months, and has the ability to use thermometers, scales, and fill out diary cards; 4) Have not received pneumococcal vaccine or pertussis vaccine, and have no history of receiving other live vaccines in the past 14 days or non live vaccines in the past 7 days; 5) Underarm temperature ≤ 37.0 ℃.
Exclusion criteria
* A history of invasive diseases caused by Streptococcus pneumoniae that has been confirmed through cultivation; * Known to be allergic to any component of the experimental vaccine, especially those allergic to diphtheria toxoid, or those who previously have a fever of 39.5 ℃ or above after receiving vaccine; * History or family history of seizures, epilepsy, encephalopathy, and mental illness; * Infants born with abnormal labor processes (difficult labor, instrumental delivery) or with a history of asphyxia or neurological organ damage; * A history of confirmed thrombocytopenia or other coagulation disorders may result in contraindications for subcutaneous injection; * Injecting human normal immunoglobulin after birth; * Known or suspected immunological dysfunction, receiving immunosuppressive therapy (radiation therapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), such as continuous treatment with systemic corticosteroids (prednisone or similar drugs) for ≥ 14 days, human immunodeficiency virus (HIV) infection, etc; * Having congenital malformations, severe malnutrition, developmental disorders, and genetic defects (such as favism); * Currently suffering from serious chronic diseases, infectious diseases, active infections, liver diseases, kidney diseases, cardiovascular diseases, and malignant tumors; * Severe asthma; * Systemic rash, skin ringworm, skin suppuration or blisters; * Currently or planning to participate in clinical trials of other drugs in the near future; Researchers believe that any situation that may affect the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody positive conversion rate | 30 days after full vaccination | The positive conversion rates of diphtheria antibody (anti-D), tetanus antibody (anti-T), pertussis toxin antibody (anti-PT), and pertussis filamentous hemagglutinin antibody (anti-FHA) in P+DTP, P-DTP, and DTP groups，respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Solicited AEs within 0-7 days after vaccination | 0-7 days after vaccination | The occurrence of all solicited adverse events within 0-7 days after each dose of vaccination |
| Unsolicited AEs within 0-30 days after vaccination | 0-30 days after vaccination | The occurrence of all unsolicited adverse events within 0-30 days after each dose of vaccination. |
| AEs within 0-30 minutes after vaccination | 0-30 minutes after vaccination | The occurrence of all adverse events within 0-30 minutes after each dose of vaccination |
| Positive rate of IgG antibodies | 30 days after full vaccination | Positive rate of susceptible individuals with 15 serotype specific pneumococcal IgG antibodies (percentage of subjects with antibody concentration ≥ 0.35 μ g/ml) |
| GMC of IgG antibody | 30 days after full vaccination | GMC of IgG antibody against 15 serotype specific pneumococcal. |
| SAE within 0-6 months after primary immunization | 0-6 months after primary immunization | The occurrence of all serious adverse events within 0-6 months after primary immunization. |
Countries
China
Outcome results
None listed