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Clinical Trial of the 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
Sponsor: CanSino Biologics Inc.
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
Conditions
Interventions
24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M)
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
PCV24 vaccine (dose H)
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
PCV24 vaccine (dose M)
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
23-valent pneumococcal polysaccharide vaccine (referred to as PPV23)
1 dose ( 0.5ml) of PPV23 vaccine
PCV24 vaccine (dose M)
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
13-valent pneumococcal polysaccharide conjugate vaccine (referred to as PCV13)
1 dose ( 0.5ml) of PCV13 vaccine
PCV24 vaccine (dose H)
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
PPV23 vaccine
1 dose ( 0.5ml) of PPV23 vaccine
PCV24 vaccine (dose H)
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
PCV13 vaccine
1 dose ( 0.5ml) of PCV13 vaccine
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
PCV24 vaccine (dose L or M or H)
1 dose ( 0.5ml) of PCV24 vaccine (dose L or M or H)
PPV23 vaccine
1 dose ( 0.5ml) of PPV23 vaccine
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.
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.