Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
2026-08-05
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.
Locations (2)
Ningling County Center for Disease Control and Prevention
Shangqiu, China
Xiangcheng County Center for Disease Control and Prevention
Xuchang, China