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NOT YET 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

2026-05-22

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.