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Pneumococcal Infectious DiseasePhase 2NCT07333352

PCV24 Clinical Trial in Infants and Young Children Aged 2 Months (Minimum 6 Weeks) to 71 Months

A Phase 2 study testing 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) and 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13) in people with Pneumococcal Infectious Disease, run by Reinovax Biologics Co., LTD at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Phase II clinical trial of the 24-valent pneumococcal polysaccharide conjugate vaccine (RZ700) will be carried out in infants and young children aged 2 months (minimum 6 weeks) to 71 months. Read more about this study

Who is it for?
Ages 6 weeks to 71 monthsHealthy volunteers can take part
Conditions the study is for
Pneumococcal Infectious Disease
What is being tested?
24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) and 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
7 sitesChina
Study dates
11 Sep 2025to 14 Apr 2026
Phase
Phase 2
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 6 weeks to 71 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy subjects aged 2 months (minimum 6 weeks) and 7-71 months, whose guardians can provide valid identification documents for both the subjects and themselves, as well as proof of their guardianship relationship.
  • The guardians of the subjects voluntarily agree to their participation in this trial, sign the Informed Consent Form (ICF), and are willing to comply with all requirements of this clinical trial protocol.
  • The guardians of the subjects have the ability to understand the trial procedures (non-illiterate).

Who cannot join

  • Subjects who have received any type of pneumococcal vaccine prior to enrollment, plan to receive a pneumococcal vaccine during the trial, or have a history of invasive diseases caused by Streptococcus pneumoniae (confirmed by any clinical, serological, or microbiological method).
  • Subjects with abnormal physical examination results that are deemed clinically significant by a clinician.
  • Subjects with suspected or confirmed fever (axillary temperature ≥ 37.5℃) within 3 days prior to enrollment; or those with an axillary temperature ≥ 37.5℃ on the day before the first dose of vaccination.
  • Subjects with a history of acute illness, acute exacerbation of chronic illness, systemic use of antibiotics or antiviral drugs within 3 days prior to the first dose of vaccination; or those who have taken antipyretic, analgesic, or antiallergic drugs (e.g., acetaminophen, ibuprofen, loratadine, cetirizine, etc.) within 3 days prior to the first dose of vaccination.
  • Subjects with a history of allergy to any component of the study vaccine, any vaccine containing tetanus toxoid, or a previous history of severe allergy to any vaccine or drug (including but not limited to anaphylactic shock, allergic laryngeal edema, allergic purpura, immune thrombocytopenic purpura, local allergic necrotizing reaction, dyspnea, angioedema, etc.); or a previous history of the aforementioned severe adverse reactions following the use of any vaccine or drug.
  • Subjects who have received inactivated vaccines, subunit vaccines, or recombinant vaccines within 7 days prior to enrollment; or live attenuated vaccines, adenovirus vector vaccines, etc., within 14 days prior to enrollment.
Show all 18Show fewer
  • Subjects who have received any other investigational drugs within 3 months prior to enrollment or plan to use them during the trial; those who have received whole blood, plasma, or blood products (e.g., immunoglobulin therapy) within 3 months prior to enrollment or plan to receive such treatments during the trial.
  • Subjects with a history of thrombocytopenia, idiopathic thrombocytopenic purpura, or other coagulation disorders diagnosed by a hospital; or a history of receiving anticoagulant therapy.
  • Subjects with a known current or past history of infectious diseases diagnosed by a hospital, such as active tuberculosis, hepatitis B, hepatitis C, HIV infection, etc.
  • Subjects with known or suspected severe chronic diseases (e.g., liver and kidney diseases, malignant tumors, infectious or allergic skin diseases, hemolytic uremic syndrome); or those whose condition is in the progressive stage and cannot be stably controlled.
  • Infants aged 2 months (minimum 6 weeks) and 7-11 months with abnormal birth weight (<2500g), abnormal gestational age (<37 weeks or >42 weeks), abnormal delivery (dystocia, instrumental delivery), or a history of asphyxia or neuroorganic damage.
  • Infants aged 2 months (minimum 6 weeks) and 7-11 months with severe eczema or severe jaundice (grade 3 or above).
  • Subjects with severe congenital malformations, developmental disorders, genetic defects, severe malnutrition, or severe chronic diseases (e.g., tetralogy of Fallot, tricuspid atresia, Down syndrome, sickle cell anemia, etc.).
  • Subjects with neurological diseases or neurodevelopmental disorders (e.g., febrile convulsions, epilepsy, encephalopathy, focal neurological deficits, encephalomyelitis or transverse myelitis, Guillain-Barré syndrome); or a history of mental illness in the subjects themselves or their biological parents.
  • Subjects with a history of congenital or acquired immunodeficiency, immunosuppression, or autoimmune diseases; or those who have received immunomodulatory therapy within 6 months (e.g., immunosuppressive doses of glucocorticoids [dosage reference: equivalent to prednisone ≥0.5mg/kg/day for more than 2 weeks], monoclonal antibodies, thymopeptides, interferons, etc.); or plan to receive such treatments from enrollment to 30 days after the last dose of vaccination. Topical medications (e.g., ointments, eye drops, inhalants, or nasal sprays) are permitted.
  • Subjects with asplenia, functional asplenia, or asplenia/resplenectomy caused by any condition.
  • Subjects whose guardians may be unable to comply with trial procedures, adhere to agreements, plan to permanently relocate from the region before the trial is completed, or be away from the local area for a long time during scheduled visits.
  • Researchers believe that the subject has any other factors that make them unsuitable for participating in the clinical trial, such that continued participation cannot ensure the subject's maximum benefit.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites
  • Luzhou District Center for Disease Control and Prevention

    Changzhi, Shanxi, 046011

  • Qinxian County Center for Disease Control and Prevention

    Changzhi, Shanxi, 046400

  • Kuangqu District Center for Disease Control and Prevention of Yangquan City

    Yangquan, Shanxi, 045000

  • Xinjiang County Center for Disease Control and Prevention

    Yuncheng, Shanxi, 043100

  • Jishan County Center for Disease Control and Prevention

    Yuncheng, Shanxi, 043200

  • Yongji City Center for Disease Control and Prevention

    Yuncheng, Shanxi, 044500

  • Shangdang District Center for Disease Control and Prevention of Changzhi City

    Yuncheng, Shanxi, 047100

Other trials in China

About this study

Official title: Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of A 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) in Infants and Young Children Aged 2 Months (Minimum 6 Weeks) to 71 Months

The Phase II clinical trial of the 24-valent pneumococcal polysaccharide conjugate vaccine (RZ700) will be carried out in infants and young children aged 2 months (minimum 6 weeks) to 71 months. The purpose of this study is to evaluate the immunogenicity and safety of the 24-valent pneumococcal polysaccharide conjugate vaccine.

Being tested
24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700), 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)
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 (RZ700)Biological

    24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) consisting of polysaccahrides from 24 pneumococcal serotypes: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F conjugated two carrier proteins. Each dose contains 0.5 ml vaccine in a prefilled syringe.

  • 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)Biological

    13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13) consisting of plosaccharides from 13 pneumococcal serotypes: 1, , 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F conjugated CRM197. Each dose contains 0.5 ml vaccine in a prefilled syringe.

Study groups in NCT07333352
Study groupRoleWhat they receive
Cohort I :2 months (minimum 6 weeks)of age.ExperimentalSubjects aged 2 months (minimum 6 weeks) will receive the experimental vaccine or comparator control vaccine according to 0, 2, and 4-month immunization schedule, followed by a booster dose at 12-15 months of age.
Receives: Biological: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700); Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)
Cohort II : 7~23 months of age.ExperimentalSubjects aged 7-11 months will receive the experimental vaccine or comparator control vaccine according to the 0 and 2-month immunization schedule. A booster dose will be administered at 12-15 months of age. Accprdingly, subjects aged 12-23 months will receive the experimental vaccine or comparator control vaccine according to the 0 and 2-month immunization schedule.
Receives: Biological: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700); Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)
Cohort III : 24~71 months of age.ExperimentalSubjects aged 24-71 months will receive a single intramuscular injection of the experimental vaccine or comparator control vaccineon the day of enrollment.
Receives: Biological: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700); Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects with the pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml.

    Proportion of subjects with the pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml.

    Measured: 30 days post the primary and booster immunization.

Secondary outcomes (10)
  1. The proportion of subjects with serum IgG antibody concentration ≥1.0 μg/ml against 24 serotypes of Streptococcus pneumoniae.

    The proportion of subjects aged 2 months (minimum 6 weeks old) and 7~71 months old with serum IgG antibody concentration ≥1.0 μg/ml against 24 serotypes of Streptococcus pneumoniae.

    Measured: 30 days after completion of the primary immunization schedule

  2. Pneumococcal serotype-specific IgG antibody geometric mean fold rise (GMFR) against 24 serotypes post immunization compared with pre-immunization.

    Pneumococcal serotype-specific IgG antibody geometric mean fold rise (GMFR) against 24 serotypes in subjects aged 2 months (minimum 6 weeks old) and 7~71 months old compared with pre-immunization.

    Measured: 30 days after completion of the primary immunization schedule.

  3. Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) .

    Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) for each serotype (1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F) in subjects aged 2 months (minimum 6 weeks old) and 7~71 months old at 30 days after completion of the primary immunization.

    Measured: 30 days after completion of the primary immunization schedule

  4. The proportion of subjects with serum IgG antibody concentration ≥1.0 μg/ml against 24 serotypes of Streptococcus pneumoniae.

    The proportion of subjects aged 2 months (minimum 6 weeks old) and 7~11 months old with serum IgG antibody concentration ≥1.0 μg/ml against 24 serotypes of Streptococcus pneumoniae.

    Measured: 30 days after completion of the booster immunization schedule

  5. The proportion of subjects with serum MOPA titer ≥1:8 against Streptococcus pneumoniae.

    The proportion of subjects in the MOPA testing subgroup aged 24~71 months with serum MOPA titer ≥1:8 against Streptococcus pneumoniae.

    Measured: 30 days after vaccination

  6. Geometric Mean Titer (GMT) of pneumococcal serotype-specific MOPA antibodies in serum.

    Pneumococcal serotype-specific MOPA geometric mean titer (GMT) in serum of subjects aged 24~71 months in the MOPA testing subgroup.

    Measured: 30 days after vaccination

  7. Pneumococcal serotype-specific MOPA geometric mean titer fold rise (GMFR) in serum.

    Pneumococcal serotype-specific MOPA geometric mean titer fold rise (GMFR) in serum of subjects aged 24~71 months in the MOPA testing subgroup.

    Measured: 30 days after vaccination

  8. Incidence rate of all adverse events (AEs).

    Incidence rate of all adverse events (AEs) within 30 minutes, 7 days, and 30 days after each dose of vaccination in each age group.

    Measured: Within 30 days after each dose of vaccination

  9. Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs).

    12~71 months old: Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs).

    Measured: From the first dose of vaccination to 6 months after completion of the full vaccination course

  10. Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs).

    2 months old (minimum 6 weeks old)and 7 to 11 months old: Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs).

    Measured: From the first dose of the primary immunization course to 6 months after completion of the booster immunization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start11 Sep 2025
  3. Primary completion14 Apr 2026
  4. Study completion14 Apr 2026

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07333352
Sponsor's protocol ID
RNCVCT7B002
Status last verified
Jul 2026
First submitted
1 Dec 2025
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) and 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13) in people with Pneumococcal Infectious Disease, run by Reinovax Biologics Co., LTD at 7 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 3 inclusion and 18 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 phase mean?

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?

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?

Proportion of subjects with the pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml. (time frame: 30 days post the primary and booster immunization.). 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 27 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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