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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6+
SponsorCanSino Biologics Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Individuals aged 2 months (minimum 6 weeks), 7 months to 5 years, and 18 years and older who are willing to provide identification

The trial participant and/or guardian (legal representative) has voluntarily signed the informed consent form after providing informed consent

Children aged 5 and under who have not previously received a pneumococcal vaccine

People aged 18 and older who have not received a pneumonia vaccine in the past five years

Disqualifiers

Preterm birth (delivery before 37 weeks of gestation), low birth weight (<2500 g at birth), history of labor abnormalities or resuscitation due to asphyxia; (Applicable to individuals in Phase I and Phase II who are 2 months of age or older (minimum 6 weeks))

Patients with abnormal results in pre-vaccination blood tests (including complete blood count, blood chemistry, and coagulation function) or urinalysis, which the investigator determines to be clinically significant; (Applicable only to Phase I participants aged 2 years (or 7 months) and older)

Individuals who are allergic to the active ingredient of the vaccine, any of its inactive ingredients, or substances used in the manufacturing process; or those who have previously experienced an allergic reaction after receiving a similar vaccine; Individuals with a history of severe allergic reactions to vaccines (such as acute allergic reactions, angioedema, or difficulty breathing), or a history of severe allergic reactions to any vaccine, food, or medication, including urticaria, anaphylactic shock, eczema, allergic respiratory distress, angioedema, or a history of asthma

Individuals with uncontrolled hypertension (as measured on-site: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg); (Applicable to Stage II participants aged 50 and older and Stage I participants aged 18 and older)

Trial design

Treatments tested in this trial

  • 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M)
  • PCV24 vaccine (dose H)
  • PCV24 vaccine (dose M)
  • 23-valent pneumococcal polysaccharide vaccine (referred to as PPV23)
  • PCV24 vaccine (dose M)
  • 13-valent pneumococcal polysaccharide conjugate vaccine (referred to as PCV13)
  • PCV24 vaccine (dose H)
  • PPV23 vaccine
  • PCV24 vaccine (dose H)
  • PCV13 vaccine
  • PCV24 vaccine (dose M)
  • PCV13 vaccine
  • PCV24 vaccine (dose H)
  • PCV13 vaccine
  • PCV24 vaccine (dose L)
  • PCV13 vaccine
  • PCV24 vaccine (dose M)
  • PCV13 vaccine
  • PCV24 vaccine (dose H)
  • PCV13 vaccine
  • PCV24 vaccine (dose L or M or H)
  • PPV23 vaccine
  • PCV24 vaccine (dose L or M or H)
  • PCV13 vaccine

Treatment groups

854 Participants
are divided into 24 treatment groups

24

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators

CanSino Biologics Inc.

Lead sponsor