This is a randomized, blinded, peer-controlled study. There will be 3 treatment groups, screened subjects were randomized in a 1:1:1 ratio to receive three batches of the DTcP trial vaccine, and completed the primary immunization according to the procedure of one dose each at 2, 4, and 6 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
780
Three doses of basic immunization were completed at 2, 4 and 6 months of age
Three doses of basic immunization were completed at 2, 4 and 6 months of age
Changge Center for Disease Control and Prevention
Xuchang, Henan, China
Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.
Time frame: 30 days after vaccination
Seroconversion rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.
Time frame: 30 days after vaccination
Seropositivity rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine
Time frame: 30 days after vaccination
Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects.
Time frame: Within 30 minutes post-vaccination
Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects.
Time frame: Within 0-7 days
Incidence of unsolicited adverse reactions for each vaccine dose in 2-month-old subjects.
Time frame: Within 0-30 days
Incidence of Serious Adverse Events (SAEs) in 2-month-old subjects.
Time frame: From first vaccination to 30 days after the third dose
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Three doses of basic immunization were completed at 2, 4 and 6 months of age