Streptococcus Pneumoniae InfectionPhase 1/2NCT07600983
Clinical Trial of the 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
A Phase 1/2 study testing 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M), PCV24 vaccine (dose H) and PCV24 vaccine (dose M) in people with Streptococcus Pneumoniae Infection, run by CanSino Biologics Inc. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumoniae Infection
- What is being tested?
- 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M), PCV24 vaccine (dose H) and PCV24 vaccine (dose M)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 854 participants
- Where
- 2 sitesChina
- Study dates
- 24 May 2026to 30 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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):
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- 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
Who cannot join
- 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
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- 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
- According to the researchers' assessment, the trial participants had other factors that made them unsuitable for participation in the clinical trial
- Individuals who experienced a severe allergic reaction following the previous dose of the vaccine
- Individuals who experienced a serious adverse reaction causally related to a previous dose of the vaccine
- Other potential causes ruled out by the researchers
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Ningling County Center for Disease Control and Prevention
Shangqiu
Qing Shao
- Recruiting
Xiangcheng County Center for Disease Control and Prevention
Xuchang
Longfei Wang
About this study
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
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.
Read the detailed description
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.
- Conditions
- Streptococcus Pneumoniae Infection
- Being tested
- 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), 13-valent pneumococcal polysaccharide conjugate vaccine (referred to as PCV13)
- Keywords
- Vaccine, Individuals aged 2 months (minimum 6 weeks) and older, Polysaccharide binding, Safety, Immunogenicity
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
PCV24 vaccine (dose H)Biological
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
PCV24 vaccine (dose M)Biological
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
23-valent pneumococcal polysaccharide vaccine (referred to as PPV23)Biological
1 dose ( 0.5ml) of PPV23 vaccine
PCV24 vaccine (dose M)Biological
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
13-valent pneumococcal polysaccharide conjugate vaccine (referred to as PCV13)Biological
1 dose ( 0.5ml) of PCV13 vaccine
PCV24 vaccine (dose H)Biological
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
PPV23 vaccineBiological
1 dose ( 0.5ml) of PPV23 vaccine
PCV24 vaccine (dose H)Biological
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
PCV13 vaccineBiological
1 dose ( 0.5ml) of PCV13 vaccine
PCV24 vaccine (dose M)Biological
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 vaccineBiological
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)Biological
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 vaccineBiological
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)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.
PCV13 vaccineBiological
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)Biological
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 vaccineBiological
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)Biological
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 vaccineBiological
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)Biological
1 dose ( 0.5ml) of PCV24 vaccine (dose L or M or H)
PPV23 vaccineBiological
1 dose ( 0.5ml) of PPV23 vaccine
PCV24 vaccine (dose L or M or H)Biological
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 vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Phase 1, Medium dose, 18~49 year-old | Experimental | This arm is open to all Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: PCV13 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence of adverse reactions
Measured: Within 7 days of receiving each dose of the vaccine
Phase I: Incidence of adverse reactions
Measured: Within 30 days of receiving each dose of the vaccine
Phase I: Incidence of serious adverse event (SAE)
Measured: 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
Measured: 4 days after vaccination
Phase I: Incidence of abnormalities in complete blood count
Measured: 4 days after vaccination
Phase I: Incidence of abnormalities in blood chemistry
Measured: 4 days after vaccination
Phase I: Incidence of abnormalities in coagulation function
Measured: 4 days after vaccination
Phase II (≥50 years old group): Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibodies
Measured: 30 days after vaccination
Phase II (≥50 years old group): ≥4-fold increase of serotype-specific pneumococcal IgG antibodies
Measured: 30 days after vaccination
Phase II (≥50 years old group): Geometric mean increment (GMI) of serotype-specific pneumococcal IgG antibodies
Measured: 30 days after vaccination
Phase II (≥50 years old group): Serotype-specific pneumococcal OPA antibody titers in some trial participants
Measured: 30 days after vaccination
Phase II (≥50 years old group): Proportion of trial participants with serotype-specific pneumococcal OPA antibody titers ≥1:8
Measured: 30 days after vaccination
Phase II (≥50 years old group): Incidence of adverse reactions
Measured: Within 7 days of vaccination
Phase II (≥50 years old group): Incidence of adverse reactions
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 7 days of each dose
Phase II (2-month-old group [minimum 6 weeks]): Incidence of adverse reactions
Measured: Within 30 days of each dose
Secondary outcomes (16)
Phase I: Incidence of adverse reactions
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days after vaccination
Phase I (≥50 years old group): ≥4-fold increaseof Serotype-specific pneumococcal IgG antibody
Measured: 30 days after vaccination
Phase I (≥50 years old group): GMI of Serotype-specific pneumococcal IgG antibody
Measured: 30 days after vaccination
Phase I (≥50 years old group): Serotype-specific pneumococcal OPA antibody titers
Measured: 30 days after vaccination
Phase I (≥50 years old group): Proportion of serotype-specific pneumococcal OPA antibody titers ≥1:8
Measured: 30 days after vaccination
Phase II (≥50 years old group): Incidence of adverse reactions
Measured: Within 30 days of vaccination
Phase II (≥50 years old group): Incidence of SAE
Measured: Within 180 days of vaccination
Phase II (2-month-old group [minimum 6 weeks]): Incidence of adverse reactions
Measured: Within 30 days of each dose
Phase II (2-month-old group [minimum 6 weeks]): Incidence of SAE
Measured: Within 180 days of receiving the first dose of the vaccine through the booster shot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start24 May 2026
- Primary completion24 Nov 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Pneumoniae InfectionStudies of the same condition, open and under way.
- More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 854 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhiqiang Xie, Master, Principal investigator, Henan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600983
- Sponsor's protocol ID
- CTP-PCV24-001
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07600983
- Acronym / sponsor ID
- CTP-PCV24-001
- Conditions
- Streptococcus Pneumoniae Infection
- Keywords
- Vaccine, Individuals aged 2 months (minimum 6 weeks) and older, Polysaccharide binding, Safety, Immunogenicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 854 participants (estimated)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2026 (actual)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 24
| Arm | Type | Receives |
|---|---|---|
| Phase I, Phase 1, Medium dose, 18~49 year-old | Experimental | Biological: 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M)This arm is open to all |
| Phase I, Phase 2, High dose, 18~49 year-old | Experimental | Biological: PCV24 vaccine (dose H)This arm is open to all |
| Phase I, Phase 2, Medium dose, 50 years of age or older | Experimental | 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. |
| Phase I, Phase 2, 50 years of age or older | Active comparator | 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. |
| Phase I, Phase 2, Medium dose, 2~5 year-old | Experimental | 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. |
| Phase I, Phase 2, 2~5 year-old | Active comparator | 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. |
| Phase I, Phase 3, High dose, 50 years of age or older | Experimental | 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. |
| Phase I, Phase 3, 50 years of age or older | Active comparator | Biological: PPV23 vaccineParticipants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio. |
| Phase I, Phase 3, High dose, 2~5 year-old | Experimental | 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. |
| Phase I, Phase 3, 2~5 year-old | Active comparator | Biological: PCV13 vaccineParticipants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio. |
| Phase I, Phase 4, Medium dose, 7~23 month-old | Experimental | 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. |
| Phase I, Phase 4, 7~23 month-old | Active comparator | Biological: PCV13 vaccineParticipants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio. |
| Phase I, Phase 5, High dose, 7~23 month-old | Experimental | 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. |
| Phase I, Phase 5, 7~23 month-old | Active comparator | Biological: PCV13 vaccineParticipants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio. |
| Phase I, Phase 5, low dose, 2 months old (minimum 6 weeks) | Experimental | 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. |
| Phase I, Phase 5, 2 months old (minimum 6 weeks) | Active comparator | Biological: PCV13 vaccineParticipants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio. |
| Phase I, Phase 6, Medium dose, 2 months old (minimum 6 weeks) | Experimental | 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. |
| Phase I, Phase 6, 2 months old (minimum 6 weeks) | Active comparator | Biological: PCV13 vaccineParticipants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio. |
| Phase I, Phase 7, High dose, 2 months old (minimum 6 weeks) | Experimental | 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. |
| Phase I, Phase 7, 2 months old (minimum 6 weeks) | Active comparator | Biological: PCV13 vaccineParticipants in this age arm were randomly assigned to the experimental group and the control group in a 2:1 ratio. |
| Phase II, Low or medium or High dose, 50 years of age or older | Experimental | 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. |
| Phase II, 50 years of age or older | Active comparator | Biological: PPV23 vaccineParticipants in this age arm were randomly assigned to the experimental group and the control group in a 1:1 ratio. |
| Phase II, Low or medium or High dose, 2 months old (minimum 6 weeks) | Experimental | 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. |
| Phase II, 2 months old (minimum 6 weeks) | Active comparator | Biological: PCV13 vaccineParticipants in this age arm were randomly assigned to the experimental group and the control group in a 3:1 ratio. |
Who may qualify
- Ages
- 6 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- People aged 50 and older who are willing to provide identification documents
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M)1 dose ( 0.5ml) of PCV24 vaccine (dose M) | Biological | Phase I, Phase 1, Medium dose, 18~49 year-old |
| PCV24 vaccine (dose H)1 dose ( 0.5ml) of PCV24 vaccine (dose H) | Biological | Phase I, Phase 2, High dose, 18~49 year-old |
| PCV24 vaccine (dose M)1 dose ( 0.5ml) of PCV24 vaccine (dose M) | Biological | Phase I, Phase 2, Medium dose, 50 years of age or older |
| 23-valent pneumococcal polysaccharide vaccine (referred to as PPV23)1 dose ( 0.5ml) of PPV23 vaccine | Biological | Phase I, Phase 2, 50 years of age or older |
| PCV24 vaccine (dose M)1 dose ( 0.5ml) of PCV24 vaccine (dose M) | Biological | Phase I, Phase 2, Medium dose, 2~5 year-old |
| 13-valent pneumococcal polysaccharide conjugate vaccine (referred to as PCV13)1 dose ( 0.5ml) of PCV13 vaccine | Biological | Phase I, Phase 2, 2~5 year-old |
| PCV24 vaccine (dose H)1 dose ( 0.5ml) of PCV24 vaccine (dose H) | Biological | Phase I, Phase 3, High dose, 50 years of age or older |
| PPV23 vaccine1 dose ( 0.5ml) of PPV23 vaccine | Biological | Phase I, Phase 3, 50 years of age or older |
| PCV24 vaccine (dose H)1 dose ( 0.5ml) of PCV24 vaccine (dose H) | Biological | Phase I, Phase 3, High dose, 2~5 year-old |
| PCV13 vaccine1 dose ( 0.5ml) of PCV13 vaccine | Biological | Phase I, Phase 3, 2~5 year-old |
| 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. | Biological | Phase I, Phase 4, Medium dose, 7~23 month-old |
| PCV13 vaccineIf 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. | Biological | Phase I, Phase 4, 7~23 month-old |
| 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. | Biological | Phase I, Phase 5, High dose, 7~23 month-old |
| PCV13 vaccineIf 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. | Biological | Phase I, Phase 5, 7~23 month-old |
| 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. | Biological | Phase I, Phase 5, low dose, 2 months old (minimum 6 weeks) |
| PCV13 vaccineThe 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. | Biological | Phase I, Phase 5, 2 months old (minimum 6 weeks) |
| 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. | Biological | Phase I, Phase 6, Medium dose, 2 months old (minimum 6 weeks) |
| PCV13 vaccineThe 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. | Biological | Phase I, Phase 6, 2 months old (minimum 6 weeks) |
| 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. | Biological | Phase I, Phase 7, High dose, 2 months old (minimum 6 weeks) |
| PCV13 vaccineThe 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. | Biological | Phase I, Phase 7, 2 months old (minimum 6 weeks) |
| PCV24 vaccine (dose L or M or H)1 dose ( 0.5ml) of PCV24 vaccine (dose L or M or H) | Biological | Phase II, Low or medium or High dose, 50 years of age or older |
| PPV23 vaccine1 dose ( 0.5ml) of PPV23 vaccine | Biological | Phase II, 50 years of age or older |
| 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. | Biological | Phase II, Low or medium or High dose, 2 months old (minimum 6 weeks) |
| PCV13 vaccineA 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. | Biological | Phase II, 2 months old (minimum 6 weeks) |
Primary outcome
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
16 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhiqiang Xie, Master principal investigator
Henan Provincial Center for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M), PCV24 vaccine (dose H) and PCV24 vaccine (dose M) in people with Streptococcus Pneumoniae Infection, run by CanSino Biologics Inc. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haojie Liu (022-58213600-6051, haojie.liu@cansinotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Incidence of adverse reactions (time frame: Within 7 days of receiving each dose of the vaccine). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.