Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate Immunogenicity and safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged 2 and 3 months.

Official Title
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A Single-center, Randomised, Blind, Similar Vaccine Control, Non-inferior Designed Phase III Clinical Trial to Evaluate Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers

Conditions
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Pneumonia, Pneumococcal

Intervention / Treatment
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* Biological: 15-Valent Pneumococcal Conjugate Vaccine
* Biological: 13-Valent Pneumococcal Conjugate Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged above 2 months (minimum to 6 weeks), term (37-42 weeks gestation) and birth weight ≥2.5 kg. The guardian understands the vaccination and research procedures, volunteers to participate in the research and sign the informed consent. The guardian can follow the clinical research program, will be able to follow up until 3 years after booster immunization and have the ability to use thermometers, scale and fill in diary and contact cards as required. There was no history of other live vaccines in the past 14 days and no history of other inactivated vaccines in the seventh day. Subaxillary body temperature <=37.0 C. Determine health based on medical history, physical examination, and researcher's judgment. Exclusion Criteria: Have been vaccinated a listed or experimental pneumococcal vaccine. History of invasive diseases caused by Streptococcus pneumoniae confirmed by bacterial culture in the past. In the past, there was any history of vaccination or serious allergy to drugs. In the past, fever of over 39.5 C related to vaccination occurred in biological products for vaccination and prophylaxis. History of convulsion, epilepsy, encephalopathy and psychiatry or family history. Had abnormal labor (dystocia, device midwifery), history of asphyxia rescue and nerve organ damage. History of pathological jaundice confirmed by diagnosis. A history of thrombocytopenia or other coagulation disorders with definite diagnosis. Human serum gamma globulin injection after birth. There are known or suspected immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc. Congenital malformations, severe malnutrition, developmental disorders, genetic defects (e.g. broad bean disease). Severe chronic disease, infectious disease, active infection, liver disease, kidney disease, cardiovascular disease, malignant tumor. Severe asthma. Systemic rash, dermatophytes, skin pus or blister. Participation in other drug clinical trials. Anything that the researcher considers likely to affect the evaluation of the study.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Received Vaccine: 15-valent pneumococcal Conjugate Vaccine(experimental vaccine), 0.5 ml/dose | Biological: 15-Valent Pneumococcal Conjugate Vaccine<br>* 4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.<br>|
| Active Comparator: Positive control group<br>Received Vaccine: 13-valent pneumococcal Conjugate Vaccine(positive control vaccine), 0.5 ml/dose | Biological: 13-Valent Pneumococcal Conjugate Vaccine<br>* 4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity study endpoint | Percentage of participants with seroresponse to each vaccination | 30 day after each vaccination | 
| Safety study endpoint | Occurrence of adverse events during a 30 day follow-up period after each vaccination | 30 day after each vaccination |