Consistency, Immunogenicity, and Safety of Three Batches of 15-valent Pneumococcal Conjugate Vaccine

Healthy Volunteers Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

The purpose of this experiment

1. evaluate the consistency of clinical immune efficacy of three batches of commercially produced 15-valent pneumococcal conjugate vaccines.

2. Compare the immunogenicity of commercial scale produced 15-valent pneumococcal conjugate vaccines in the 3-month-old population with the immunogenicity (non inferiority) of pilot scale produced 15-valent pneumococcal conjugate vaccines, that is, a clinical bridging study between commercial scale vaccines and Phase III clinical trial vaccines.

3. Evaluate the immunogenicity and safety of the 15-valent pneumococcal conjugate vaccine in the 7-5-year-old population after vaccination.

The commercial three batches and pilot scale batches were designed using a randomized, double-blind, parallel controlled trial of different batches of vaccines. The commercial three batches adopt equivalence design, and the immunogenicity results of the three batches are merged on the basis of equivalence, and compared with the immunogenicity of the pilot scale batch for non-inferiority.

Compare the immunogenicity data of the 7-5-year-old population experimental group with the immunogenicity results of the 3-month-old group (after merging three commercial batches on an equivalent basis) at the basic immune stage for non-inferiority.

At the same time, a positive control was established in the 7-month-5-year-old population, and a randomized, blind design was used to compare the immunogenicity of the experimental group and the control group in this age group.

The study population consists of a total of 2346 people, including 1104 people at the age of 3 months, divided into four groups with 276 people in each group. They were assigned to batch 1, batch 2, batch 3, and the pilot scale module at a ratio of 1:1:1:1. There are a total of 1242 people aged 7 months to 5 years old, divided into three age groups: 7-11 months old, 12-23 months old, and 2-5 years old, with 414 people in each age group. Three age groups of participants were randomly assigned to the experimental group or control group in a 2:1 ratio. The experimental group received a 15-valent pneumococcal conjugate vaccine (batch 3), while the control group received a 13-valent pneumococcal polysaccharide conjugate vaccine produced by Yuxi Watson Biotechnology Co., Ltd. Among them:

1. 3 months old: Basic immunization according to the 0, 1, and 2 month program (window period:+10 days); Strengthen immunization with 1 dose at the age of 12-15 months.

2. 7-11 months of age: basic immunization with a 0 to 2-month program (window period:+10 days); After 12 months of age, strengthen the vaccination with 1 dose (3rd dose), with a minimum interval of 2 months between the 2nd dose.

3. 12-23 months old: Immunize with 2 doses of 0 and 2 month program. The interval between two doses of vaccination should be at least 2 months (window period:+10 days).

4. 2-5 years old: receive 1 dose. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT05939219
• Study type: Interventional
• Source: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Contact: Wenjian Fang, master
• Phone: 18611630252
• Email: fangwenjian@zhifeishengwu.com
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Completion date: June 30, 2025