Pneumonia, Pneumococcal
Conditions
Brief summary
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.
Interventions
BIOLOGICAL15-Valent Pneumococcal Conjugate Vaccine
4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
BIOLOGICAL13-Valent Pneumococcal Conjugate Vaccine
4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
Sponsors
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 3 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity study endpoint | 30 day after each vaccination | Percentage of participants with seroresponse to each vaccination |
| Safety study endpoint | 30 day after each vaccination | Occurrence of adverse events during a 30 day follow-up period after each vaccination |
Countries
China
Outcome results
None listed