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

NCT07333352 | Recruiting Phase 2

• 1 other identifier: RNCVCT7B002
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 7

Brief 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. The purpose of this study is to evaluate the immunogenicity and safety of the 24-valent pneumococcal polysaccharide conjugate vaccine.

Conditions

Pneumococcal Infectious Disease

Outcome Measures

Primary Outcomes (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.

  30 days post the primary and booster immunization.

Secondary Outcomes (10)

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

  30 days after completion of the primary immunization schedule

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

  30 days after completion of the primary immunization schedule.

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

  30 days after completion of the primary immunization schedule

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

  30 days after completion of the booster immunization schedule

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

  30 days after vaccination

Study Arms (3)

Cohort I :2 months (minimum 6 weeks）of age.

EXPERIMENTAL

Subjects 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.

Biological: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700); Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)

Cohort II : 7~23 months of age.

EXPERIMENTAL

Subjects 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.

Biological: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700); Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)

Cohort III : 24~71 months of age.

EXPERIMENTAL

Subjects aged 24-71 months will receive a single intramuscular injection of the experimental vaccine or comparator control vaccineon the day of enrollment.

Biological: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700); Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)

Interventions

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.

Cohort I :2 months (minimum 6 weeks）of age.; Cohort II : 7~23 months of age.; Cohort III : 24~71 months of age.

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.

Cohort I :2 months (minimum 6 weeks）of age.; Cohort II : 7~23 months of age.; Cohort III : 24~71 months of age.

Eligibility Criteria

• Age: 6 Weeks - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Reinovax Biologics Co.,LTD: lead

Study Sites (7)

Luzhou District Center for Disease Control and Prevention

Changzhi, Shanxi, 046011, China

RECRUITING

Qinxian County Center for Disease Control and Prevention

Changzhi, Shanxi, 046400, China

RECRUITING

Kuangqu District Center for Disease Control and Prevention of Yangquan City

Yangquan, Shanxi, 045000, China

RECRUITING

Xinjiang County Center for Disease Control and Prevention

Yuncheng, Shanxi, 043100, China

RECRUITING

Jishan County Center for Disease Control and Prevention

Yuncheng, Shanxi, 043200, China

RECRUITING

Yongji City Center for Disease Control and Prevention

Yuncheng, Shanxi, 044500, China

RECRUITING

Shangdang District Center for Disease Control and Prevention of Changzhi City

Yuncheng, Shanxi, 047100, China

RECRUITING

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

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

Study Officials

• Yunong Zhang, Master

  Shanxi Province Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator ，Yunong Zhang，Master

CONTACT

13485383983; 474584051@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 12, 2026
• Study Start: September 11, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)