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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 14
- 主要终点
- Proportion of subjects with the pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
- •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.
研究组 & 干预措施
Cohort I :2 months (minimum 6 weeks）of age.
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.
干预措施: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13) (Biological)
Cohort II : 7~23 months of age.
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.
干预措施: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) (Biological)
Cohort II : 7~23 months of age.
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.
干预措施: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13) (Biological)
Cohort III : 24~71 months of age.
Subjects aged 24-71 months will receive a single intramuscular injection of the experimental vaccine or comparator control vaccineon the day of enrollment.
干预措施: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) (Biological)
Cohort III : 24~71 months of age.
Subjects aged 24-71 months will receive a single intramuscular injection of the experimental vaccine or comparator control vaccineon the day of enrollment.
干预措施: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13) (Biological)
Cohort I :2 months (minimum 6 weeks）of age.
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.
干预措施: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) (Biological)
结局指标
主要结局
Proportion of subjects with the pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml.
时间窗: 30 days post the primary and booster immunization.
Proportion of subjects with the pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml.
次要结局
- 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)
- Geometric Mean Titer (GMT) of pneumococcal serotype-specific MOPA antibodies in serum.(30 days after vaccination)
- 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 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 MOPA geometric mean titer fold rise (GMFR) in serum.(30 days after vaccination)
- Incidence rate of all adverse events (AEs).(Within 30 days after each dose of vaccination)
- Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs).(From the first dose of vaccination to 6 months after completion of the full vaccination course)
- Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs).(From the first dose of the primary immunization course to 6 months after completion of the booster immunization)