The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children 1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1 month apart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,560
0.5ml, intramuscular
0.5ml, intramuscular
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan, China
RECRUITINGNumber of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL
Time frame: 28 days after last dose of primary vaccination
Number of Subjects With Any Solicited Local and General Symptoms
Time frame: Within 7 days after any vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within 28 days after any vaccination
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Time frame: 28 days after last dose of primary vaccination
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