Phase I Clinical Trial of PCV24 in Children Aged 2 Months (Minimum 6 Weeks) to 17 Years

NCT06675032 | Active Not Recruiting Phase 1

• 1 other identifier: RNCVCT7B001
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in children aged 2 Months (Minimum 6 Weeks) to 17 Years . The objective of the study is to evaluate the safety tolerability and immunogenicity of PCV24. The trial is a randomized, blind, controlled combined placebo and positive vaccine control I clinical trial.

Conditions

Pneumococcal Infectious Disease

Outcome Measures

Primary Outcomes (1)

• 2 months ~17 years old incidence of adverse events AE

  At the 30 day after every dose vaccination

Secondary Outcomes (6)

• Incidence of clinically significant abnormality in laboratory examination tests

  Day 0 before vaccination and day 4 after vaccination

• Incidence of serious adverse events (SAE) and

  0-6 months after vaccination

• Incidence of serious adverse events (SAE)

  0-6 months after vaccination

• Proportion of Pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)

  30 days after vaccination

• Proportion of Pneumococcal serotype-specific IgG antibody concentration ≥1.0 μg/ml

  30 days after vaccination

Study Arms (10)

6~17 years old( PCV24 formulation 1)

EXPERIMENTAL

Dosage form: injection Specification: 0.5 ml/piece Dosage: The preferred part for infants is the anterolateral thigh (vastus lateralis), and the deltoid muscle of the upper arm for toddlers and children, with a dose of 0.5 ml per 1 human use. Duration of medication: 24 months of age-17 years of age: 1 dose.

Biological: PCV24 formulation 1; Biological: Sodium Chloride Injection

6~17 years old(PCV24 formulation 2）

EXPERIMENTAL

Specification: 0.5 ml/piece Dosage: The preferred part for infants is the anterolateral thigh (vastus lateralis), and the deltoid muscle of the upper arm for toddlers and children, with a dose of 0.5 ml per 1 human use. Duration of medication: 24 months of age-17 years of age: 1 dose.

Biological: PCV24 formulation 2; Biological: Sodium Chloride Injection

24-71 months of age( PCV24 formulation 1)

EXPERIMENTAL

Specification: 0.5 ml/piece Dosage: The preferred part for infants is the anterolateral thigh (vastus lateralis), and the deltoid muscle of the upper arm for toddlers and children, with a dose of 0.5 ml per 1 human use. Duration of medication: 24 months of age-17 years of age: 1 dose.

Biological: PCV24 formulation 1; Biological: Sodium Chloride Injection

24-71 months of age(PCV24 formulation 2)

EXPERIMENTAL

Specification: 0.5 ml/piece Dosage: The preferred part for infants is the anterolateral thigh (vastus lateralis), and the deltoid muscle of the upper arm for toddlers and children, with a dose of 0.5 ml per 1 human use. Duration of medication: 24 months of age-17 years of age: 1 dose.

Biological: PCV24 formulation 2; Biological: Sodium Chloride Injection

12-23 months of age( PCV24 formulation 1)

EXPERIMENTAL

Dosage form: injection Specification: 0.5 ml/piece Dosage: The preferred part for infants is the anterolateral thigh (vastus lateralis), and the deltoid muscle of the upper arm for toddlers and children, with a dose of 0.5 ml per 1 human use. Duration of medication: 12-23 months age group: 2 doses, at least 2 months apart.

Biological: PCV24 formulation 1; Biological: Sodium Chloride Injection

12-23 months of age( PCV24 formulation 2)

EXPERIMENTAL

Dosage form: injection Specification: 0.5 ml/piece Dosage: The preferred part for infants is the anterolateral thigh (vastus lateralis), and the deltoid muscle of the upper arm for toddlers and children, with a dose of 0.5 ml per 1 human use. Duration of medication: 12-23 months age group: 2 doses, at least 2 months apart.

Biological: PCV24 formulation 2; Biological: Sodium Chloride Injection

7~11 months of age( PCV24 formulation 1)

EXPERIMENTAL

Dosage form: injection Specification: 0.5 ml/piece Dosage: The preferred part for infants is the anterolateral thigh (vastus lateralis), and the deltoid muscle of the upper arm for toddlers and children, with a dose of 0.5 ml per 1 human use. Duration of medication: 7-11 months age group: 2 doses of primary immunization, with an interval of at least 1 month between the first two doses, and 1 booster dose after 12 months of age.

Biological: PCV24 formulation 1; Biological: Sodium Chloride Injection

7~11 months of age(PCV24 formulation 2)

EXPERIMENTAL

Dosage form: injection Specification: 0.5 ml/piece Dosage: The preferred part for infants is the anterolateral thigh (vastus lateralis), and the deltoid muscle of the upper arm for toddlers and children, with a dose of 0.5 ml per 1 human use. Duration of medication: 7-11 months age group: 2 doses of primary immunization, with an interval of at least 1 month between the first two doses, and 1 booster dose after 12 months of age.

Biological: PCV24 formulation 2; Biological: Sodium Chloride Injection

2~3 months old (minimum) (6 weeks of age)( PCV24 formulation 1)

EXPERIMENTAL

Dosage form: injection Specification: 0.5 ml/piece Dosage: The preferred part for infants is the anterolateral thigh (vastus lateralis), and the deltoid muscle of the upper arm for toddlers and children, with a dose of 0.5 ml per 1 human use. Duration of medication: 6 weeks to 3 months: one dose at the age of 2, 4 and 6 months for basic immunization, one dose at the age of 12\~15 months for booster immunization, and the first dose at the earliest age of 6 weeks.

Biological: PCV24 formulation 1; Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; Biological: Sodium Chloride Injection

2~3 months old (minimum) (6 weeks of age)( PCV24 formulation 2)

EXPERIMENTAL

Dosage form: injection Specification: 0.5 ml/piece Dosage: The preferred part for infants is the anterolateral thigh (vastus lateralis), and the deltoid muscle of the upper arm for toddlers and children, with a dose of 0.5 ml per 1 human use. Duration of medication: 6 weeks to 3 months: one dose at the age of 2, 4 and 6 months for basic immunization, one dose at the age of 12\~15 months for booster immunization, and the first dose at the earliest age of 6 weeks.

Biological: PCV24 formulation 2; Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; Biological: Sodium Chloride Injection

Interventions

PCV24 formulation 2 BIOLOGICAL

24-Valent Pneumococcal Polysaccharide Conjugate Vaccine formulation 2：Dosage form: Injection Specification:0.5 ml/strip Dosage: The preferred site is the anterolateral thigh (lateral femoral muscle) in infants and the deltoid muscle of the upper arm in infants and children. The preferred dosage for infants is 0.5 ml per dose. Dosing schedule:24 months old-17 years old group: 1 dose.12-23 months old group: 2 doses, each dose at least 2 months apart.7-11 months old group: 2 doses of basic immunization, the first two doses at least 1 month apart, and a booster dose after 12 months of age.6 weeks months: 1 dose of basic immunization at each of the ages of 2, 4, and 6 months, and 1 dose of booster immunization at the age of 12-15 months, with the earliest of the first dose at the age of 6 weeks. The first dose is given at 6 weeks of age at the earliest.

Also known as: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine

12-23 months of age( PCV24 formulation 2); 24-71 months of age(PCV24 formulation 2); 2~3 months old (minimum) (6 weeks of age)( PCV24 formulation 2); 6~17 years old(PCV24 formulation 2）; 7~11 months of age(PCV24 formulation 2)

Sodium Chloride Injection BIOLOGICAL

Sodium Chloride Injection：Dosage form: Injection Specification:0.5 ml/strip Dosage: The preferred site is the anterolateral thigh (lateral femoral muscle) in infants and the deltoid muscle of the upper arm in infants and children. The preferred dosage for infants is 0.5 ml per dose. Dosing schedule:24 months old-17 years old group: 1 dose.12-23 months old group: 2 doses, each dose at least 2 months apart.7-11 months old group: 2 doses of basic immunization, the first two doses at least 1 month apart, and a booster dose after 12 months of age.6 weeks months: 1 dose of basic immunization at each of the ages of 2, 4, and 6 months, and 1 dose of booster immunization at the age of 12-15 months, with the earliest of the first dose at the age of 6 weeks. The first dose is given at 6 weeks of age at the earliest.

12-23 months of age( PCV24 formulation 1); 12-23 months of age( PCV24 formulation 2); 24-71 months of age( PCV24 formulation 1); 24-71 months of age(PCV24 formulation 2); 2~3 months old (minimum) (6 weeks of age)( PCV24 formulation 1); 2~3 months old (minimum) (6 weeks of age)( PCV24 formulation 2); 6~17 years old( PCV24 formulation 1); 6~17 years old(PCV24 formulation 2）; 7~11 months of age( PCV24 formulation 1); 7~11 months of age(PCV24 formulation 2)

PCV24 formulation 1 BIOLOGICAL

24-Valent Pneumococcal Polysaccharide Conjugate Vaccine formulation 1：Dosage form: Injection Specification:0.5 ml/strip Dosage: The preferred site is the anterolateral thigh (lateral femoral muscle) in infants and the deltoid muscle of the upper arm in infants and children. The preferred dosage for infants is 0.5 ml per dose. Dosing schedule:24 months old-17 years old group: 1 dose.12-23 months old group: 2 doses, each dose at least 2 months apart.7-11 months old group: 2 doses of basic immunization, the first two doses at least 1 month apart, and a booster dose after 12 months of age.6 weeks months: 1 dose of basic immunization at each of the ages of 2, 4, and 6 months, and 1 dose of booster immunization at the age of 12-15 months, with the earliest of the first dose at the age of 6 weeks. The first dose is given at 6 weeks of age at the earliest.

Also known as: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine

12-23 months of age( PCV24 formulation 1); 24-71 months of age( PCV24 formulation 1); 2~3 months old (minimum) (6 weeks of age)( PCV24 formulation 1); 6~17 years old( PCV24 formulation 1); 7~11 months of age( PCV24 formulation 1)

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine BIOLOGICAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine:Dosage form: Injection Specification:0.5 mL/strip Dosage: The preferred site for infants is the anterolateral thigh (lateral femoral muscle), and for toddlers and children, the deltoid muscle of the upper arm. Dosing schedule:6 weeks months: 4 doses, one dose each of basic immunization at 2, 4, and 6 months of age, and one dose of booster immunization at 12-15 months of age, with the earliest of the first dose being given at 6 weeks of age. The first dose should be given at 6 weeks of age at the earliest.

Also known as: Prevenar13®

2~3 months old (minimum) (6 weeks of age)( PCV24 formulation 1); 2~3 months old (minimum) (6 weeks of age)( PCV24 formulation 2)

Eligibility Criteria

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

You may qualify if:

• Healthy subjects aged 2\~3 months (minimum 6 weeks old) and 7 months old\~17 years old, and the guardian of the subject can provide valid identification of the subject and the guardian of the subject.
• Subjects and/or their guardians voluntarily consent to the subjects to participate in this study and sign the informed consent form.
• Subjects and/or their guardians have the ability to understand (non-illiterate) study procedures.
• Female subjects and male subjects of childbearing age agree to use effective contraceptive measures within 6 months from the start of the study to the date of immunization.
• Those who have completed the full course of primary immunization in accordance with the requirements of this clinical trial, and the age before the booster immunization is 12\~15 months old, (the interval between the booster immunization time and the last dose of primary immunization is at least 2 months).
• In the opinion of the investigator, the subject's guardian can comply with all the requirements of this clinical trial protocol during the booster phase of the subject.

You may not qualify if:

• Individuals who have previously received any type of pneumococcal vaccine or have a history of invasive disease caused by Streptococcus pneumoniae (confirmed by clinical, serological, or microbiological methods).
• Abnormal results from physical examinations or laboratory tests that are deemed clinically significant by a clinician.
• Individuals suspected or diagnosed with fever (axillary temperature ≥37.5℃) within 3 days prior to enrollment; or axillary temperature ≥37.3℃ (for those over 14 years old) or ≥37.5℃ (for those 14 years old or younger) on the day of the first vaccine dose.
• Within 7 days prior to the first dose of vaccination, there is a history of acute illness or acute exacerbation of chronic disease, and systemic application of antibiotics and antiviral medications has been administered; within 3 days prior to the first dose of vaccination, antipyretics, analgesics, and antihistamines (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) have been taken.
• A history of severe allergy to any component of the vaccine being tested, or a history of severe allergy to any vaccine containing tetanus toxoid, or a previous history of severe allergy to any vaccine or medication (including but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reactions, difficulty breathing, angioedema, etc.); or a previous history of severe adverse reactions after the use of any vaccine or medication.
• Subjects who have received inactivated vaccines, subunit vaccines, or recombinant vaccines within 7 days prior to enrollment in the study, or who have received live attenuated vaccines or adenoviral vector vaccines within 14 days prior to enrollment in the study.
• Participants who have received or plan to use any other investigational drug within 3 months prior to the study; those who have received whole blood, plasma, and/or blood products, such as immunoglobulin treatment, within the last 3 months.
• History of thrombocytopenia or other coagulation disorders diagnosed by a hospital, or history of anticoagulant treatment.
• Known to have a current or past history of infectious diseases, such as active tuberculosis, hepatitis B, hepatitis C, and/or human immunodeficiency virus (HIV) infection.
• Known or suspected to have serious chronic diseases, such as liver and kidney diseases, malignant tumors, infections, or allergic skin diseases; or those whose condition is in a progressive stage and cannot be stably controlled.
• Infants under 1 year old with abnormal birth weight (less than 2500 g), or abnormal gestational age (gestational age less than 37 weeks or more than 42 weeks), and those born with abnormal delivery (dystocia, instrumental delivery) or with a history of asphyxia or neurological organ damage.
• Infants under 1 year old have severe eczema or severe jaundice.
• Individuals with severe congenital malformations, developmental disorders, genetic defects, severe malnutrition, or serious chronic diseases (such as Down syndrome, sickle cell anemia, neurological disorders, Guillain-Barré syndrome, etc.).
• Neurological diseases or neurodevelopmental disorders (e.g., febrile seizures, epilepsy, encephalopathy, focal neurological deficits, myelitis or transverse myelitis); history of psychosis or family history.
• History of congenital or acquired immunodeficiency, immunosuppression, or autoimmune diseases, or having received immunomodulatory treatment within the last 6 months, such as immunosuppressive doses of corticosteroids (dose reference: equivalent to prednisone 20 mg/day for more than 7 days); or monoclonal antibodies; or thymosin; or interferons, etc.; but local medications (such as ointments, eye drops, inhalants, or nasal sprays) are allowed.

Sponsors & Collaborators

• Shanghai Reinovax Biologics Co.,LTD: lead
• Shaanxi Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

Luzhou District Center for Disease Control and Prevention, Changzhi City

Changzhi, Shanxi, China

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yunong Zhang, Master

  Shanxi Province Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: April 27, 2024
• Primary Completion: May 10, 2025
• Study Completion: March 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)