Clinical trial
Clinical Study on the Consistency of 15-valent Pneumococcal Conjugate Vaccine in Three Batches of 3-month-old Population and the Immunogenicity and Safety of Vaccination in 7-5-year-old Population
Name
202204025
Description
The objective of this clinical trial is to evaluate the consistency of the 15-valent pneumococcal conjugate vaccine in three batches of the 3-month-old population, as well as the immunogenicity and safety of vaccination in the 7-5-year-old population
Trial arms
Trial start
2023-07-01
Estimated PCD
2025-01-31
Trial end
2025-06-30
Status
Recruiting
Treatment
15-valent pneumococcal conjugate vaccine 202210001
Immunization program and dosage:3 month old group: basic immunization at 0, 1, and 2 months, and strengthened immunization at 12 to 15 months old, with a total of 4 doses administered. 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered
Arms:
3-month-old group
15-valent pneumococcal conjugate vaccineY202210002
Immunization program and dosage: 3 month old group: basic immunization at 0, 1, and 2 months, and strengthened immunization at 12 to 15 months old, with a total of 4 doses administered. 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered
Arms:
3-month-old group
15-valent pneumococcal conjugate vaccineY202210003
Immunization program and dosage: 3 month old group: basic immunization at 0, 1, and 2 months, and strengthened immunization at 12 to 15 months old, with a total of 4 doses administered. 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered
Arms:
3-month-old group
15-valent pneumococcal conjugate vaccineY202210004
Immunization program and dosage: 3 month old group: basic immunization at 0, 1, and 2 months, and strengthened immunization at 12 to 15 months old, with a total of 4 doses administered. 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered
Arms:
12-23 months old experimental group, 2-5 year old experimental group, 3-month-old group, 7-11 month old experimental group
13 valent pneumococcal polysaccharide conjugate vaccine
Immunization program and dosage: 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered
Arms:
12-23 months old control group, 2-5 year old control group, 7-11 month old control group
Size
2346
Primary endpoint
Geometric mean concentration of vaccine Serotype specific pneumococcal IgG antibody
30 days after basic immunization at 3 months old and 7-11 months old, and 30 days after full immunization at 12-23 months old and 2-5 years old
Vaccine Serotype specific pneumococcal IgG antibody concentration ≥ 0.35 μg/ml of proportion of subjects
30 days after basic immunization at 3 months old and 7-11 months old, and 30 days after full immunization at 12-23 months old and 2-5 years old
Eligibility criteria
Inclusion Criteria:
* Healthy infants and children aged 3 months, 7 months, and 5 years old;
* Infants under 1 year old should be born at full term (37 to 42 weeks of pregnancy) and have a birth weight within the range of (2500g ≤ body weight ≤ 4500g);
* After informed consent, the Legal guardian voluntarily signs the informed consent form and can comply with the requirements of the clinical research scheme;
* The subject has no history of receiving other live attenuated vaccines within ≤ 14 days, and no history of receiving other non live vaccines within ≤ 7 days;
* Underarm temperature ≤ 37.0 ℃.
Exclusion Criteria:
* Previously received commercially available or experimental pneumococcal vaccines;
* Have a history of invasive disease caused by Streptococcus pneumoniae that has been confirmed by culture in the past;
* Have a history of severe allergies to vaccines or medication;
* Have a history of Nervous system disease such as convulsion, epilepsy, nervous system tumor, craniocerebral trauma, psychiatric history or family history;
* Babies born under the age of 1 year with severe abnormal birth process (such as instrumental delivery) or a history of asphyxia or neurological organ damage;
* Patients with pathological jaundice confirmed by current diagnosis;
* A history of clearly diagnosed thrombocytopenia or other coagulation disorders may lead to contraindications for injection;
* Immunoglobulin or any blood products (except hepatitis B immunoglobulin) were given within 3 months before enrollment;
* Known or suspected to have immunological function defects, and received long-term Immunosuppressive drug treatment (radiotherapy, chemotherapy, Corticosteroid, antimetabolics, cytotoxic drugs), HIV infection or HIV infected parents within six months before vaccination;
* Having severe congenital malformations, severe malnutrition, developmental disorders, or genetic defects (such as broad bean disease);
* Currently suffering from serious chronic disease, infectious disease, active infection, liver disease, kidney disease, cardiovascular disease, and malignant tumor;
* Absence of spleen or deficiency of spleen function caused by any circumstances;
* Systemic rash, skin ringworm, skin suppuration or blisters;
* Participating in other clinical trials;
* Any situation that the researcher believes may affect the evaluation of the study.
Protocol
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Updated at
2023-07-12
1 organization
2 products
1 indication
Organization
Beijing Zhifei Lvzhu BiopharmaceuticalIndication
Healthy Control Participants