Clinical Trial of the 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)

Summary

This clinical trial consists of Phase I and Phase II. The objective is to evaluate the safety and immunogenicity of the 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) in individuals aged 2 months (minimum 6 weeks) and older.

Conditions

• Streptococcus Pneumoniae Infection

Interventions

BIOLOGICAL

24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M)

1 dose ( 0.5ml) of PCV24 vaccine (dose M)

BIOLOGICAL

PCV24 vaccine (dose H)

1 dose ( 0.5ml) of PCV24 vaccine (dose H)

BIOLOGICAL

PCV24 vaccine (dose M)

1 dose ( 0.5ml) of PCV24 vaccine (dose M)

BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine (referred to as PPV23)

1 dose ( 0.5ml) of PPV23 vaccine

BIOLOGICAL

PCV24 vaccine (dose M)

1 dose ( 0.5ml) of PCV24 vaccine (dose M)

BIOLOGICAL

13-valent pneumococcal polysaccharide conjugate vaccine (referred to as PCV13)

1 dose ( 0.5ml) of PCV13 vaccine

BIOLOGICAL

PCV24 vaccine (dose H)

1 dose ( 0.5ml) of PCV24 vaccine (dose H)

BIOLOGICAL

PPV23 vaccine

1 dose ( 0.5ml) of PPV23 vaccine

BIOLOGICAL

PCV24 vaccine (dose H)

1 dose ( 0.5ml) of PCV24 vaccine (dose H)

BIOLOGICAL

PCV13 vaccine

1 dose ( 0.5ml) of PCV13 vaccine

BIOLOGICAL

PCV24 vaccine (dose M)

If trial participants are 12-23 months of age, they should receive 2 doses (0.5ml) of PCV24 ( dose M) , administered two months apart. If trial participants are 7-11 months of age, they should receive 2 doses ( 0.5ml) of PCV24 ( dose M) as a primary series, administered two months apart; a booster dose should be administered at 12-15 months of age, at least two months after the second dose.

BIOLOGICAL

PCV13 vaccine

If trial participants are 12-23 months of age, they should receive 2 doses (0.5ml) of PCV13, administered two months apart. If trial participants are 7-11 months of age, they should receive 2 doses ( 0.5ml) of PCV13 as a primary series, administered two months apart; a booster dose should be administered at 12-15 months of age, at least two months after the second dose.

BIOLOGICAL

PCV24 vaccine (dose H)

If trial participants are 12-23 months of age, they should receive 2 doses ( 0.5ml) of PCV24 (dose H) , administered two months apart. If trial participants are 7-11 months of age, they should receive 2 doses ( 0.5ml) of PCV24 ( dose H) as a primary series, administered two months apart; a booster dose should be administered at 12-15 months of age, at least two months after the second dose.

BIOLOGICAL

PCV13 vaccine

If trial participants are 12-23 months of age, they should receive 2 doses ( 0.5ml) of PCV13 , administered two months apart. If trial participants are 7-11 months of age, they should receive 2 doses ( 0.5ml) of PCV13 as a primary series, administered two months apart; a booster dose should be administered at 12-15 months of age, at least two months after the second dose.

BIOLOGICAL

PCV24 vaccine (dose L)

The primary vaccination series consists of 3 doses ( 0.5ml) of the PCV24 vaccine ( dose L) , administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.

BIOLOGICAL

PCV13 vaccine

The primary vaccination series consists of 3 doses ( 0.5ml) of the PCV13 vaccine, administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.

BIOLOGICAL

PCV24 vaccine (dose M)

The primary vaccination series consists of 3 doses of the PCV24 vaccine ( 0.5ml) , administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.

BIOLOGICAL

PCV13 vaccine

The primary vaccination series consists of 3 doses of the PCV13 vaccine ( 0.5ml) , administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.

BIOLOGICAL

PCV24 vaccine (dose H)

The primary vaccination series consists of 3 doses of the PCV24 vaccine ( 0.5ml) , administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.

BIOLOGICAL

PCV13 vaccine

The primary vaccination series consists of 3 doses of the PCV13 vaccine ( 0.5ml) , administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.

BIOLOGICAL

PCV24 vaccine (dose L or M or H)

1 dose ( 0.5ml) of PCV24 vaccine (dose L or M or H)

BIOLOGICAL

PPV23 vaccine

1 dose ( 0.5ml) of PPV23 vaccine

BIOLOGICAL

PCV24 vaccine (dose L or M or H)

A primary vaccination series consisting of 3 doses of the PCV24 vaccine ( 0.5ml) , with a 2-month interval between each dose; a single booster dose should be administered at 12 to 15 months of age.

BIOLOGICAL

PCV13 vaccine

A primary vaccination series consisting of 3 doses of the PCV13 vaccine ( 0.5ml) , with a 2-month interval between each dose; a single booster dose should be administered at 12 to 15 months of age.

Sponsors & Collaborators

• CanSino Biologics Inc.

  lead INDUSTRY

Principal Investigators

• Zhiqiang Xie, Master · Henan Provincial Center for Disease Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-24

Primary Completion

2026-11-24

Completion

2027-12-30