Diphtheria, Tetanus and Acellular Pertussis
Conditions
Keywords
Vaccine, Three Components, Immunogenicity, Safety, 2 months old
Brief summary
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.
Interventions
BIOLOGICALDiphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1)
Three doses of basic immunization were completed at 2, 4 and 6 months of age
BIOLOGICALDiphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2)
Three doses of basic immunization were completed at 2, 4 and 6 months of age
BIOLOGICALDiphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3)
Three doses of basic immunization were completed at 2, 4 and 6 months of age
Sponsors
CanSino Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Days to 89 Days
Healthy volunteers
Yes
Inclusion criteria
* 2 months of age (60\ 89 days), willing to provide identification documents; * The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and can comply with the requirements of the clinical research protocol.
Exclusion criteria
First dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 30 days after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 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 | 30 days after vaccination |
| Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects. | Within 30 minutes post-vaccination |
| Incidence of unsolicited adverse reactions for each vaccine dose in 2-month-old subjects. | Within 0-30 days |
| Incidence of Serious Adverse Events (SAEs) in 2-month-old subjects. | From first vaccination to 30 days after the third dose |
Countries
China
Outcome results
None listed