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

Pneumonia, Pneumococcal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04357522
• Other study ID #: 201904002
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 2020
• Est. completion date: March 2026

Study information

• Verified date: April 2020
• Source: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1950
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Pneumococcal

Intervention

Biological:
• 15-Valent Pneumococcal Conjugate Vaccine
4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
• 13-Valent Pneumococcal Conjugate Vaccine
4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.

Locations

Country	Name	City	State
China	Daming Center for Disease Control and Prevention	Daming	Hebei
China	Laishui Center for Disease Control and Prevention	Laishui	Hebei
China	Zhengding Center for Disease Control and Prevention	Zhengding	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity study endpoint	Percentage of participants with seroresponse to each vaccination	30 day after each vaccination
Primary	Safety study endpoint	Occurrence of adverse events during a 30 day follow-up period after each vaccination	30 day after each vaccination