PneumoniaPhase 1NCT05815264
Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above
A Phase 1 study testing 23-valent pneumococcal polysaccharide vaccine and pneumococcal vaccine polyvalent in people with Pneumonia, run by Ab&B Bio-tech Co., Ltd.JS at 1 site in China.
Trial summary
The group aged 18-59 years old, the group ≥60 years old, and the group aged 2-17 years old were successively assigned to the group. Subjects in each age group were randomly vaccinated with 1 dose of experimental vaccine or control vaccine in a ratio of 1:1, with 48 people in each group receiving each dose. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- 23-valent pneumococcal polysaccharide vaccine and pneumococcal vaccine polyvalent
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2020to 6 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ≥2 years old healthy population;
- Subjects and/or guardians or trustees voluntarily signed informed consent forms and could comply with the requirements of the clinical trial protocol;
- Had not received any pneumonia vaccine in the last 5 years；
- Note: Healthy people do not include the following conditions: ① congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; ② History of epilepsy and mental illness; ③ Patients with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases; Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases; ⑤ serious liver and kidney diseases, malignant tumors, all kinds of acute diseases or in the acute phase of chronic disease; Adults have diabetes, severe cardiovascular disease, and high blood pressure (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) that cannot be controlled by medication.
Who cannot join
- Armpit temperature >37.0℃ before inoculation;
- Family history of seizures or convulsions, epilepsy, and mental illness;
- People with a progressive neurological disorder or a history of Guillain-Barre syndrome;
- The patients with clinically significant abnormalities in blood biochemistry and routine blood tests were tested before vaccination；
- People who received immunoenhancement or suppressant therapy within 3 months (continuous oral or intravenous infusion for more than 14 days);
- History of abnormal coagulation function (such as deficiency of coagulation factor, coagulation disease);
Show all 13Show fewer
- Primary and secondary immunocompromised individuals (thyroid, pancreas, liver, spleen excision history, or need treatment for thyroid disease within the last 12 months);
- History of severe allergic reactions to vaccinations;
- Allergy to any component of the investigational vaccine;
- Have received live attenuated vaccine within 14 days; Other vaccines received within 7 days;
- Participating in or planning to participate in other clinical trials;
- Women of childbearing age are lactating, pregnant or planning to become pregnant in the near future;
- The investigator determined that other conditions were not suitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blind, Parallel Controlled Phase I Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Population Aged 2 Years and Older
The group aged 18-59 years old, the group ≥60 years old, and the group aged 2-17 years old were successively assigned to the group. Subjects in each age group were randomly vaccinated with 1 dose of experimental vaccine or control vaccine in a ratio of 1:1, with 48 people in each group receiving each dose. After the safety assessment was conducted on the 8th day after the first dose, the next age group could be enrolled only if the preliminary safety assessment results met the protocol requirements. When each age group is enrolled, laboratory index screening can be conducted 3 days in advance (the validity period of laboratory index detection results is 3 days). The progression of age groups is as follows:
Group 18-59 years old (48 people: 1 dose) → Group ≥60 years old (48 people: 1 dose) → Group 2-17 years old (48 people: 1 dose)
Read more
Safety observation: All subjects were observed on site for 30 minutes after vaccination, abnormal laboratory indicators (blood biochemistry, blood routine) of all subjects were observed on day 4 after vaccination, and adverse events of all subjects within 0-7 days were actively followed up by the researchers, and subjects were instructed to record the body temperature measured every day and adverse events (if they occurred) in the diary card. All subjects continued to observe adverse events within 8-28 days and made relevant records. All subjects were required to continue follow-up for SAE status up to 6 months after basic immunization.
Immunogenicity observation: Blood samples were collected before and 28 days after vaccination, and serum antibodies were detected by ELISA.
- Conditions
- Pneumonia
- Being tested
- 23-valent pneumococcal polysaccharide vaccine, pneumococcal vaccine polyvalent
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23-valent pneumococcal polysaccharide vaccineBiological
This vaccine（0.5ml） is produced by Ab\&b Biotechnology Co., Ltd.JS. Subjects will receive one dose of 23-valent pneumococcal polysaccharide vaccine administered by intramuscular injection.
pneumococcal vaccine polyvalentBiological
This vaccine（0.5ml） is produced by Merck Sharp \& Dohme Corp. Subjects will receive one dose of pneumococcal vaccine polyvalent administered by intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group aged 18-59 years | Experimental | Subjects in the age group 18-59 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine Receives: Biological: 23-valent pneumococcal polysaccharide vaccine |
| Control group aged 18-59 years | Active comparator | Subjects in the age group 18-59 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent Receives: Biological: pneumococcal vaccine polyvalent |
| Experimental group aged ≥60 years | Experimental | Subjects in the age group ≥60 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine Receives: Biological: 23-valent pneumococcal polysaccharide vaccine |
| Control group aged ≥60 years | Active comparator | Subjects in the age group ≥60 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent Receives: Biological: pneumococcal vaccine polyvalent |
| Experimental group aged 2-17 years | Experimental | Subjects in the age group 2-17 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine Receives: Biological: 23-valent pneumococcal polysaccharide vaccine |
| Control group aged 2-17 years | Active comparator | Subjects in the age group 2-17 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent Receives: Biological: pneumococcal vaccine polyvalent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any adverse event within 30 minutes after vaccination.
Incidence of any adverse event within 30 minutes after vaccination.
Measured: Within 30 minutes of vaccination
The incidence of abnormal indicators of blood biochemistry and blood routine on the 4th day after vaccination
The incidence of abnormal indicators of blood biochemistry and blood routine on the 4th day after vaccination
Measured: Within 4 days of vaccination
Incidence of any adverse event within 0-7 days after vaccination.
Incidence of any adverse event within 0-7 days after vaccination.
Measured: Within 0-7 days of vaccination
Incidence of any adverse event within 8-28 days after vaccination.
Incidence of any adverse event within 8-28 days after vaccination.
Measured: Within 8-28 days of vaccination
Incidence of any serious adverse event within 6 months after vaccination.
Incidence of any serious adverse event within 6 months after vaccination.
Measured: Within 6 months of vaccination
Secondary outcomes (2)
Serum IgG antibody seroconversion rate of subjects 28 days after vaccination.
Serum IgG antibody seroconversion rate of subjects 28 days after vaccination.
Measured: At 28 days after vaccination
Serum IgG antibody GMC of subjects 28 days after vaccination.
Serum IgG antibody GMC of subjects 28 days after vaccination.
Measured: At 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start7 Sep 2020
- Primary completion6 Apr 2021
- Study completion6 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JS
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Yanxia Wang, Principal investigator, Henan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815264
- Sponsor's protocol ID
- 2017L04947-1
- Status last verified
- Dec 2025
- First submitted
- 3 Apr 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blind, Parallel Controlled Phase I Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Population Aged 2 Years and Older
- ClinicalTrials.gov ID
- NCT05815264
- Acronym / sponsor ID
- 2017L04947-1
- Conditions
- Pneumonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JSUniversity, hospital or other
- Collaborators
- Henan Center for Disease Control and Prevention
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 18 Apr 2023 (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.
The group aged 18-59 years old, the group ≥60 years old, and the group aged 2-17 years old were successively assigned to the group. Subjects in each age group were randomly vaccinated with 1 dose of experimental vaccine or control vaccine in a ratio of 1:1, with 48 people in each group receiving each dose. After the safety assessment was conducted on the 8th day after the first dose, the next age group could be enrolled only if the preliminary safety assessment results met the protocol requirements. When each age group is enrolled, laboratory index screening can be conducted 3 days in advance (the validity period of laboratory index detection results is 3 days). The progression of age groups is as follows:
Group 18-59 years old (48 people: 1 dose) → Group ≥60 years old (48 people: 1 dose) → Group 2-17 years old (48 people: 1 dose)
Safety observation: All subjects were observed on site for 30 minutes after vaccination, abnormal laboratory indicators (blood biochemistry, blood routine) of all subjects were observed on day 4 after vaccination, and adverse events of all subjects within 0-7 days were actively followed up by the researchers, and subjects were instructed to record the body temperature measured every day and adverse events (if they occurred) in the diary card. All subjects continued to observe adverse events within 8-28 days and made relevant records. All subjects were required to continue follow-up for SAE status up to 6 months after basic immunization.
Immunogenicity observation: Blood samples were collected before and 28 days after vaccination, and serum antibodies were detected by ELISA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental group aged 18-59 years | Experimental | Biological: 23-valent pneumococcal polysaccharide vaccineSubjects in the age group 18-59 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine |
| Control group aged 18-59 years | Active comparator | Biological: pneumococcal vaccine polyvalentSubjects in the age group 18-59 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent |
| Experimental group aged ≥60 years | Experimental | Biological: 23-valent pneumococcal polysaccharide vaccineSubjects in the age group ≥60 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine |
| Control group aged ≥60 years | Active comparator | Biological: pneumococcal vaccine polyvalentSubjects in the age group ≥60 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent |
| Experimental group aged 2-17 years | Experimental | Biological: 23-valent pneumococcal polysaccharide vaccineSubjects in the age group 2-17 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine |
| Control group aged 2-17 years | Active comparator | Biological: pneumococcal vaccine polyvalentSubjects in the age group 2-17 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ≥2 years old healthy population;
- Subjects and/or guardians or trustees voluntarily signed informed consent forms and could comply with the requirements of the clinical trial protocol;
- Had not received any pneumonia vaccine in the last 5 years；
- Note: Healthy people do not include the following conditions: ① congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; ② History of epilepsy and mental illness; ③ Patients with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases; Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases; ⑤ serious liver and kidney diseases, malignant tumors, all kinds of acute diseases or in the acute phase of chronic disease; Adults have diabetes, severe cardiovascular disease, and high blood pressure (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) that cannot be controlled by medication.
Key exclusion criteria (13 listed)
- Armpit temperature >37.0℃ before inoculation;
- Family history of seizures or convulsions, epilepsy, and mental illness;
- People with a progressive neurological disorder or a history of Guillain-Barre syndrome;
- The patients with clinically significant abnormalities in blood biochemistry and routine blood tests were tested before vaccination；
- People who received immunoenhancement or suppressant therapy within 3 months (continuous oral or intravenous infusion for more than 14 days);
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 |
|---|---|---|
| 23-valent pneumococcal polysaccharide vaccineThis vaccine（0.5ml） is produced by Ab\&b Biotechnology Co., Ltd.JS. Subjects will receive one dose of 23-valent pneumococcal polysaccharide vaccine administered by intramuscular injection. | Biological | Experimental group aged 18-59 years, Experimental group aged 2-17 years, Experimental group aged ≥60 years |
| pneumococcal vaccine polyvalentThis vaccine（0.5ml） is produced by Merck Sharp \& Dohme Corp. Subjects will receive one dose of pneumococcal vaccine polyvalent administered by intramuscular injection. | Biological | Control group aged 18-59 years, Control group aged 2-17 years, Control group aged ≥60 years |
Primary outcome
Incidence of any adverse event within 30 minutes after vaccination.
Time frame: Within 30 minutes of vaccination
Incidence of any adverse event within 30 minutes after vaccination.
The incidence of abnormal indicators of blood biochemistry and blood routine on the 4th day after vaccination
Time frame: Within 4 days of vaccination
The incidence of abnormal indicators of blood biochemistry and blood routine on the 4th day after vaccination
Incidence of any adverse event within 0-7 days after vaccination.
Time frame: Within 0-7 days of vaccination
Incidence of any adverse event within 0-7 days after vaccination.
Incidence of any adverse event within 8-28 days after vaccination.
Time frame: Within 8-28 days of vaccination
Incidence of any adverse event within 8-28 days after vaccination.
Incidence of any serious adverse event within 6 months after vaccination.
Time frame: Within 6 months of vaccination
Incidence of any serious adverse event within 6 months after vaccination.
2 secondary outcomes
Serum IgG antibody seroconversion rate of subjects 28 days after vaccination.
Time frame: At 28 days after vaccination
Serum IgG antibody GMC of subjects 28 days after vaccination.
Time frame: At 28 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
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. This study is not recruiting at the moment.
Yanxia Wang principal investigator
Henan Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 23-valent pneumococcal polysaccharide vaccine and pneumococcal vaccine polyvalent in people with Pneumonia, run by Ab&B Bio-tech Co., Ltd.JS at 1 site 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any adverse event within 30 minutes after vaccination. (time frame: Within 30 minutes of vaccination). The study lists 5 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 2 Jan 2026.