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