Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world. This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
264
0.5mL, Intramuscular
0.5mL, Intramuscular
Xiangtan Maternal and Child Health Hospital
Xiangtan, Hunan, China
RECRUITINGSafety in terms of adverse reactions
Occurrence of AEs on vaccination site (local) and non-vaccination site (systemic) of each subject
Time frame: within 30 minutes post each vaccination
Safety in terms of adverse events
Occurrence of solicited AEs of each subject
Time frame: within 7 days post each vaccination
Safety in terms of adverse events
Occurrence of non-solicited AEs of each subject
Time frame: within 30 days post each vaccination
Safety in terms of SAEs
Occurrence of SAEs of each subject
Time frame: within 6 months post last vaccination
Safety in terms of laboratory-based AEs
Occurrence of laboratory-based AEs in subjects of 2 years old and above(Arm 1A-3A)
Time frame: within 4 days post each vaccination
Immunogencity in terms of seropositivity rates by ELISA
Seropositivity rates of serotype-specific pneumococcal IgG antibody in subjects of each age group
Time frame: 30 days post basic vaccination
Immunogencity in terms of GMC by ELISA
GMC of serotype-specific pneumococcal IgG antibody in subjects of each age group
Time frame: 30 days post basic vaccination
Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL
Time frame: 30 days post basic vaccination
Immunogencity Comparison with control vaccine group
Comparison of the seropositivity rates, GMC of serotype-specific pneumococcal IgG antibody and the Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL in subjects aged 2 months of Experimental group and Control group
Time frame: 30 days post basic vaccination