In order to evaluate immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine produced by Beijing Minhai Biotechnology Co., Ltd., a randomized, double-blind, parallel-controlled phase III clinical trial is planned to conduct in healthy infants aged 2 months in China.
There will be two arms. 1200 healthy infants aged 2 months will be randomly assigned (1:1) to receive an experimental vaccine or a comparator vaccine in Month 0,2 and 4 (primary vaccination). All of them will receive a fourth dose as booster vaccination in Month 10.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,200
0.5ml vaccine produced by Beijing Minhai Biotechnology Co., Ltd.,three doses with 2 month interval, a booster dose 10 months after the first dose
0.5ml vaccine produced by Wyeth,three doses with 2 month interval, a booster dose 10 months after the first dose
Huaiyin District Center for Diseases Control and Prevention
Huai'an, Jiangsu, China
Hongze District Center for Disease Control and Prevention
Huai'an, Jiangsu, China
Lianshui County Center for Disease Control and Prevention
Huai'an, Jiangsu, China
Guanyun County Center for Disease Control and Prevention
Lianyungang, Jiangsu, China
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after primary vaccination
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after primary vaccination
Time frame: 30 days after primary vaccination
Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination
Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination
Time frame: 30 days after primary vaccination
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after primary vaccination
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after primary vaccination
Time frame: 30 days after primary vaccination
Geometric mean fold increase (GMI) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination
Geometric mean fold increase (GMI) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination
Time frame: 30 days after primary vaccination
Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after primary vaccination
Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after primary vaccination
Time frame: 30 days after primary vaccination
Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after primary vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after primary vaccination
Time frame: 30 days after primary vaccination
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after booster vaccination
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after booster vaccination
Time frame: 30 days after booster vaccination
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after booster vaccination
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after booster vaccination
Time frame: 30 days after booster vaccination
Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after booster vaccination
Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after booster vaccination
Time frame: 30 days after booster vaccination
Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after booster vaccination
Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after booster vaccination
Time frame: 30 days after booster vaccination
Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after booster vaccination
Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after booster vaccination
Time frame: 30 days after booster vaccination
Incidence of adverse reactions (including systemic and local adverse reaction) 30 days after each dose of vaccination
Incidence of adverse reactions (including systemic and local adverse reaction) 30 days after each dose of vaccination
Time frame: 30 days after each dose of vaccination
Incidence of severe adverse event (SAE) within 6 months after the first doseof vaccination
Incidence of severe adverse event (SAE) within 6 months after the first doseof vaccination
Time frame: 6 months after the first doseof vaccination
Incidence of severe adverse event (SAE) 30 days after booster vaccination
Incidence of severe adverse event (SAE) 30 days after booster vaccination
Time frame: 30 days after booster vaccination