Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07600983
PHASE1/PHASE2

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

Sponsor: CanSino Biologics Inc.

View on ClinicalTrials.gov

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.

Official title: A Randomized, Blinded, Dose-Exploratory, Positive-Control Clinical Trial Evaluating the Safety and Immunogenicity of the 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid) Following Administration in Individuals Aged 2 Months (Minimum 6 Weeks) and Older

Key Details

Gender

All

Age Range

6 Weeks - Any

Study Type

INTERVENTIONAL

Enrollment

854

Start Date

2026-05-24

Completion Date

2027-12-30

Last Updated

2026-08-05

Healthy Volunteers

Yes

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.

Locations (2)

Ningling County Center for Disease Control and Prevention

Shangqiu, China

Xiangcheng County Center for Disease Control and Prevention

Xuchang, China