A Phase 1/2 interventional study of 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M) and PCV24 vaccine (dose H) in Streptococcus Pneumoniae Infection, sponsored by CanSino Biologics Inc.. Recruiting at 2 sites in China. Open to participants aged 6 Weeks and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by CanSino Biologics Inc. · Phase 1/2, Interventional, and Prevention
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.
Phase I employs a randomized, blinded, dose-escalation, positive-control design with a total sample size of 310 participants. The study population is divided into five age groups: the 18-49 age group is an open-label design with M and H dose groups; The 7-23-month, 2-5-year-old, and ≥50-year-old groups will use a positive-control, blinded design with M and H dose groups; the 2-month-old (minimum 6 weeks) group will use a positive-control, dose-escalation, and blinded design with L, M, and H dose groups. The Phase II study was divided into two age groups. The ≥50-year-old group: a randomized, blinded, active-controlled design with a total sample size of 160 participants, who were randomly assigned to the treatment and control groups in a 1:1 ratio; the 2-month-old (minimum 6 weeks) group: a randomized, blinded, active-controlled design with a total sample size of 384 participants. Participants were randomly assigned in a 3:1 ratio to the treatment groups (doses L, M, and H) and the control group.
298 studies on the registry are indexed under Pneumococcal Infections; 26 are open to participants now.
This study's planned enrollment of 854 is above the median of 373 across 253 interventional studies indexed under Pneumococcal Infections.
Browse Pneumococcal Infections studies →CanSino Biologics Inc. is the lead sponsor of 41 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Phase I:
Phase II (age ≥50 group):
Phase II (2-month-old group (minimum 6 weeks)):
Exclusion Criteria:
Exclusion criteria for the 2nd, 3rd, and 4th doses:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm is open to all
Biological: 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M)
This arm is open to all
Biological: PCV24 vaccine (dose H)
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)
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)
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)
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)
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)
Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.
Biological: PPV23 vaccine
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)
Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.
Biological: PCV13 vaccine
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)
Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.
Biological: PCV13 vaccine
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)
Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.
Biological: PCV13 vaccine
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)
Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.
Biological: PCV13 vaccine
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)
Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.
Biological: PCV13 vaccine
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)
Participants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio.
Biological: PCV13 vaccine
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)
Participants in this age arm were randomly assigned to the experimental group and the control group in a 1:1 ratio.
Biological: PPV23 vaccine
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)
Participants in this age arm were randomly assigned to the experimental group and the control group in a 3:1 ratio.
Biological: PCV13 vaccine
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
1 dose ( 0.5ml) of PPV23 vaccine
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
1 dose ( 0.5ml) of PCV13 vaccine
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
1 dose ( 0.5ml) of PPV23 vaccine
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
1 dose ( 0.5ml) of PCV13 vaccine
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
1 dose ( 0.5ml) of PCV24 vaccine (dose L or M or H)
1 dose ( 0.5ml) of PPV23 vaccine
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.
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.
Phase I: Incidence of adverse reactions
Time frame: Within 7 days of receiving each dose of the vaccine
Phase I: Incidence of adverse reactions
Time frame: Within 30 days of receiving each dose of the vaccine
Phase I: Incidence of serious adverse event (SAE)
Time frame: 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
Time frame: 4 days after vaccination
Phase I: Incidence of abnormalities in complete blood count
Time frame: 4 days after vaccination
Phase I: Incidence of abnormalities in blood chemistry
Time frame: 4 days after vaccination
Phase I: Incidence of abnormalities in coagulation function
Time frame: 4 days after vaccination
Phase II (≥50 years old group): Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibodies
Time frame: 30 days after vaccination
Phase II (≥50 years old group): ≥4-fold increase of serotype-specific pneumococcal IgG antibodies
Time frame: 30 days after vaccination
Phase II (≥50 years old group): Geometric mean increment (GMI) of serotype-specific pneumococcal IgG antibodies
Time frame: 30 days after vaccination
Phase II (≥50 years old group): Serotype-specific pneumococcal OPA antibody titers in some trial participants
Time frame: 30 days after vaccination
Phase II (≥50 years old group): Proportion of trial participants with serotype-specific pneumococcal OPA antibody titers ≥1:8
Time frame: 30 days after vaccination
Phase II (≥50 years old group): Incidence of adverse reactions
Time frame: Within 7 days of vaccination
Phase II (≥50 years old group): Incidence of adverse reactions
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Within 7 days of each dose
Phase II (2-month-old group [minimum 6 weeks]): Incidence of adverse reactions
Time frame: Within 30 days of each dose
Phase I: Incidence of adverse reactions
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 days after the primary series, 30 and 180 days after the booster dose
Phase I (2-month-old group [minimum 6 weeks]): Serotype-specific pneumococcal OPA antibody titers
Time frame: 30 days after the primary series; 30 days after the booster dose
Phase I (2-month-old group [minimum 6 weeks]): Proportion of serotype-specific pneumococcal OPA antibody titers ≥1:8
Time frame: 30 days after the primary series; 30 days after the booster dose
Phase I (≥50 years old group): GMC of Serotype-specific pneumococcal IgG antibody
Time frame: 30 days after vaccination
Phase I (≥50 years old group): ≥4-fold increaseof Serotype-specific pneumococcal IgG antibody
Time frame: 30 days after vaccination
Phase I (≥50 years old group): GMI of Serotype-specific pneumococcal IgG antibody
Time frame: 30 days after vaccination
Phase I (≥50 years old group): Serotype-specific pneumococcal OPA antibody titers
Time frame: 30 days after vaccination
Phase I (≥50 years old group): Proportion of serotype-specific pneumococcal OPA antibody titers ≥1:8
Time frame: 30 days after vaccination
Phase II (≥50 years old group): Incidence of adverse reactions
Time frame: Within 30 days of vaccination
Phase II (≥50 years old group): Incidence of SAE
Time frame: Within 180 days of vaccination
Phase II (2-month-old group [minimum 6 weeks]): Incidence of adverse reactions
Time frame: Within 30 days of each dose
Phase II (2-month-old group [minimum 6 weeks]): Incidence of SAE
Time frame: Within 180 days of receiving the first dose of the vaccine through the booster shot
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Studies of the drug tested here: PCV24