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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
480
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) 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.
Luzhou District Center for Disease Control and Prevention
Changzhi, Shanxi, China
RECRUITINGQinxian County Center for Disease Control and Prevention
Changzhi, Shanxi, China
RECRUITINGKuangqu District Center for Disease Control and Prevention of Yangquan City
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.
Time frame: 30 days post the primary and booster immunization.
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.
Time frame: 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.
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.
Time frame: 30 days after completion of the primary immunization schedule.
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.
Time frame: 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.
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.
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Yangquan, Shanxi, China
Xinjiang County Center for Disease Control and Prevention
Yuncheng, Shanxi, China
RECRUITINGJishan County Center for Disease Control and Prevention
Yuncheng, Shanxi, China
RECRUITINGYongji City Center for Disease Control and Prevention
Yuncheng, Shanxi, China
RECRUITINGShangdang District Center for Disease Control and Prevention of Changzhi City
Yuncheng, Shanxi, China
RECRUITINGTime frame: 30 days after completion of the booster immunization schedule
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.
Time frame: 30 days after vaccination
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.
Time frame: 30 days after vaccination
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.
Time frame: 30 days after vaccination
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.
Time frame: Within 30 days after each dose of vaccination
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).
Time frame: 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).
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).
Time frame: From the first dose of the primary immunization course to 6 months after completion of the booster immunization