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

NCT07600983 | Recruiting Phase 1

• 1 other identifier: CTP-PCV24-001
• Study Type: interventional
• Target: 854
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Streptococcus Pneumoniae Infection

Keywords

Vaccine; Individuals aged 2 months (minimum 6 weeks) and older; Polysaccharide binding; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (22)

• Phase I: Incidence of adverse reactions

  Within 7 days of receiving each dose of the vaccine

• Phase I: Incidence of adverse reactions

  Within 30 days of receiving each dose of the vaccine

• Phase I: Incidence of serious adverse event (SAE)

  Within 180 days of receiving the first dose of the vaccine through completion of the full vaccination series for each group

• Phase I: Incidence of abnormalities in urinalysis

  4 days after vaccination

• Phase I: Incidence of abnormalities in complete blood count

  4 days after vaccination

• Phase I: Incidence of abnormalities in blood chemistry

  4 days after vaccination

• Phase I: Incidence of abnormalities in coagulation function

  4 days after vaccination

• Phase II (≥50 years old group): Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibodies

  30 days after vaccination

• Phase II (≥50 years old group): ≥4-fold increase of serotype-specific pneumococcal IgG antibodies

  30 days after vaccination

• Phase II (≥50 years old group): Geometric mean increment (GMI) of serotype-specific pneumococcal IgG antibodies

  30 days after vaccination

• Phase II (≥50 years old group): Serotype-specific pneumococcal OPA antibody titers in some trial participants

  30 days after vaccination

• Phase II (≥50 years old group): Proportion of trial participants with serotype-specific pneumococcal OPA antibody titers ≥1:8

  30 days after vaccination

• Phase II (≥50 years old group): Incidence of adverse reactions

  Within 7 days of vaccination

• Phase II (≥50 years old group): Incidence of adverse reactions

  Within 30 days of vaccination

• Phase II (2-month-old group [minimum 6 weeks]): Positive rate of vaccine-serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml)

  30 days after the primary series, before the booster dose, and 30 days after the booster dose

• Phase II (2-month-old group [minimum 6 weeks]): Proportion with vaccine-serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/ml

  30 days after the primary series, before the booster dose, and 30 days after the booster dose

• Phase II (2-month-old group [minimum 6 weeks]): GMC of serotype-specific pneumococcal IgG antibodies

  30 days after the primary series, before the booster dose, and 30 days after the booster dose

• Phase II (2-month-old group [minimum 6 weeks]): GMI of serotype-specific pneumococcal IgG antibodies

  30 days after the primary series, before the booster dose, and 30 days after the booster dose

• Phase II (2-month-old group [minimum 6 weeks]): Serotype-specific pneumococcal OPA antibody titers in some trial participants

  30 days after the primary series; 30 days after the booster dose

• Phase II (2-month-old group [minimum 6 weeks]): Proportion of trial participants with serotype-specific pneumococcal OPA antibody titers ≥1:8

  30 days after the primary series; 30 days after the booster dose

• Phase II (2-month-old group [minimum 6 weeks]): Incidence of adverse reactions

  Within 7 days of each dose

• Phase II (2-month-old group [minimum 6 weeks]): Incidence of adverse reactions

  Within 30 days of each dose

Secondary Outcomes (16)

• Phase I: Incidence of adverse reactions

  Within 30 days of receiving each dose of the vaccine

• Phase I (2-month-old group [minimum 6 weeks]): Positive rate of vaccine-serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml)

  30 days after the primary series, 30 and 180 days after the booster dose

• Phase I (2-month-old group [minimum 6 weeks]): Proportion with vaccine-serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/ml

  30 days after the primary series, 30 and 180 days after the booster dose

• Phase I (2-month-old group [minimum 6 weeks]): GMC of serotype-specific pneumococcal IgG antibodies

  30 days after the primary series, 30 and 180 days after the booster dose

• Phase I (2-month-old group [minimum 6 weeks]): GMI of serotype-specific pneumococcal IgG antibodies

  30 days after the primary series, 30 and 180 days after the booster dose

Study Arms (24)

Phase I, Phase 1, Medium dose, 18~49 year-old

EXPERIMENTAL

This arm is open to all

Biological: 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M)

Phase I, Phase 2, High dose, 18~49 year-old

EXPERIMENTAL

This arm is open to all

Biological: PCV24 vaccine (dose H)

Phase I, Phase 2, Medium dose, 50 years of age or older

EXPERIMENTAL

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV24 vaccine (dose M)

Phase I, Phase 2, 50 years of age or older

ACTIVE COMPARATOR

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: 23-valent pneumococcal polysaccharide vaccine (referred to as PPV23)

Phase I, Phase 2, Medium dose, 2~5 year-old

EXPERIMENTAL

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV24 vaccine (dose M)

Phase I, Phase 2, 2~5 year-old

ACTIVE COMPARATOR

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: 13-valent pneumococcal polysaccharide conjugate vaccine (referred to as PCV13)

Phase I, Phase 3, High dose, 50 years of age or older

EXPERIMENTAL

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV24 vaccine (dose H)

Phase I, Phase 3, 50 years of age or older

ACTIVE COMPARATOR

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PPV23 vaccine

Phase I, Phase 3, High dose, 2~5 year-old

EXPERIMENTAL

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV24 vaccine (dose H)

Phase I, Phase 3, 2~5 year-old

ACTIVE COMPARATOR

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV13 vaccine

Phase I, Phase 4, Medium dose, 7~23 month-old

EXPERIMENTAL

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV24 vaccine (dose M)

Phase I, Phase 4, 7~23 month-old

ACTIVE COMPARATOR

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV13 vaccine

Phase I, Phase 5, High dose, 7~23 month-old

EXPERIMENTAL

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV24 vaccine (dose H)

Phase I, Phase 5, 7~23 month-old

ACTIVE COMPARATOR

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV13 vaccine

Phase I, Phase 5, low dose, 2 months old (minimum 6 weeks)

EXPERIMENTAL

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV24 vaccine (dose L)

Phase I, Phase 5, 2 months old (minimum 6 weeks)

ACTIVE COMPARATOR

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV13 vaccine

Phase I, Phase 6, Medium dose, 2 months old (minimum 6 weeks)

EXPERIMENTAL

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV24 vaccine (dose M)

Phase I, Phase 6, 2 months old (minimum 6 weeks)

ACTIVE COMPARATOR

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV13 vaccine

Phase I, Phase 7, High dose, 2 months old (minimum 6 weeks)

EXPERIMENTAL

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV24 vaccine (dose H)

Phase I, Phase 7, 2 months old (minimum 6 weeks)

ACTIVE COMPARATOR

Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.

Biological: PCV13 vaccine

Phase II, Low or medium or High dose, 50 years of age or older

EXPERIMENTAL

Participants in this age arm were randomly assigned to the experimental group and the control group in a 1:1 ratio.

Biological: PCV24 vaccine (dose L or M or H)

Phase II, 50 years of age or older

ACTIVE COMPARATOR

Participants in this age arm were randomly assigned to the experimental group and the control group in a 1:1 ratio.

Biological: PPV23 vaccine

Phase II, Low or medium or High dose, 2 months old (minimum 6 weeks)

EXPERIMENTAL

Participants in this age arm were randomly assigned to the experimental group and the control group in a 3:1 ratio.

Biological: PCV24 vaccine (dose L or M or H)

Phase II, 2 months old (minimum 6 weeks)

ACTIVE COMPARATOR

Participants in this age arm were randomly assigned to the experimental group and the control group in a 3:1 ratio.

Biological: PCV13 vaccine

Interventions

13-valent pneumococcal polysaccharide conjugate vaccine (referred to as PCV13) BIOLOGICAL

1 dose ( 0.5ml) of PCV13 vaccine

Phase I, Phase 2, 2~5 year-old

24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M) BIOLOGICAL

1 dose ( 0.5ml) of PCV24 vaccine (dose M)

Phase I, Phase 1, Medium dose, 18~49 year-old

23-valent pneumococcal polysaccharide vaccine (referred to as PPV23) BIOLOGICAL

1 dose ( 0.5ml) of PPV23 vaccine

Phase I, Phase 2, 50 years of age or older

PCV24 vaccine (dose M) BIOLOGICAL

1 dose ( 0.5ml) of PCV24 vaccine (dose M)

Phase I, Phase 2, Medium dose, 50 years of age or older

PCV24 vaccine (dose H) BIOLOGICAL

1 dose ( 0.5ml) of PCV24 vaccine (dose H)

Phase I, Phase 2, High dose, 18~49 year-old

PCV24 vaccine (dose L) BIOLOGICAL

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.

Phase I, Phase 5, low dose, 2 months old (minimum 6 weeks)

PCV24 vaccine (dose L or M or H) BIOLOGICAL

1 dose ( 0.5ml) of PCV24 vaccine (dose L or M or H)

Phase II, Low or medium or High dose, 50 years of age or older

PPV23 vaccine BIOLOGICAL

1 dose ( 0.5ml) of PPV23 vaccine

Phase I, Phase 3, 50 years of age or older

PCV13 vaccine BIOLOGICAL

1 dose ( 0.5ml) of PCV13 vaccine

Phase I, Phase 3, 2~5 year-old

Eligibility Criteria

• Age: 6 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase I:
• 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
• Phase II (age ≥50 group):
• People aged 50 and older who are willing to provide identification documents
• The trial participants voluntarily signed the informed consent form after providing their informed consent
• People aged 50 and older who have not received a pneumonia vaccine in the past five years
• Phase II (2-month-old group (minimum 6 weeks)):
• Individuals aged 2 months or older (minimum 6 weeks) who are willing to provide identification documents
• The guardian (authorized representative) of the trial participant has voluntarily signed the informed consent form after providing informed consent.
• Infants aged 2 months (minimum 6 weeks) who have not previously received a pneumococcal vaccine

You may not qualify if:

• 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)
• Women of childbearing age with a positive urine pregnancy test; participants who are breastfeeding; or participants or their partners who plan to become pregnant within the next 6 months; (Applicable to the Phase II group aged 50 or older and the Phase I group aged 18 or older)
• History of epilepsy, seizures (excluding febrile seizures), convulsions, or brain disorders \[such as congenital brain malformations, traumatic brain injury, brain tumors, cerebral hemorrhage, cerebral infarction (excluding cerebral infarctions without sequelae and lacunar infarctions), brain infections, chemical poisoning, and other conditions causing damage to brain neural tissue\], or a history of mental illness or a family history thereof; or those with other progressive neurological diseases
• Have been diagnosed with a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases
• Known or suspected acute illness or severe chronic disease (including severe respiratory disease, severe cardiovascular disease, liver or kidney disease, severe skin disease, malignant tumors, etc.); or currently experiencing an acute exacerbation of a chronic condition
• Clinically diagnosed coagulation disorders (such as coagulation factor deficiencies, coagulation disorders, or platelet abnormalities) or significant bruising or bleeding disorders
• Asplenia, functional asplenia, and asplenia or splenectomy resulting from any cause
• Patients who have received immunosuppressive therapy within 6 months prior to vaccination or who are scheduled to receive such therapy between enrollment and 1 month after completion of the vaccination series (e.g., long-term systemic corticosteroid use for ≥14 days at a dose \>2 mg/kg/day or ≥20 mg/day of prednisone or prednisone-equivalent dose) (excluding topical corticosteroids such as inhaled, nasal spray, intra-articular, eye drops, or ointments; topical use must not exceed the dose recommended in the product label or result in any signs of systemic exposure). Individuals who have used long-acting immunomodulatory drugs (e.g., infliximab) within 6 months prior to the first dose or who plan to use such drugs during the trial (applicable to the Phase II group aged ≥50 years and the Phase I group aged 7 months and older)
• Received blood products (excluding hepatitis B immunoglobulin) within 3 months prior to receiving the investigational drug
• Participation in any other clinical trial involving a drug or vaccine within the 6 months prior to enrollment, or currently participating in such a trial, or plans to participate in such a trial during the study period
• Received an injectable live attenuated vaccine within 14 days prior to receiving the investigational drug, or received any other vaccine within 7 days
• Underarm temperature of 37.3°C or higher prior to vaccination

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (2)

Ningling County Center for Disease Control and Prevention

Shangqiu, China

NOT YET RECRUITING

Xiangcheng County Center for Disease Control and Prevention

Xuchang, China

RECRUITING

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

CRM197 (non-toxic variant of diphtheria toxin); Tetanus Toxoid; Referral and Consultation; 13-valent pneumococcal vaccine; Protons

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Professional Practice; Organization and Administration; Health Services Administration; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Zhiqiang Xie, Master

  Henan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haojie Liu

CONTACT

022-58213600-6051; haojie.liu@cansinotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: May 24, 2026
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-05

Locations

CN (2)