Study of Concomitant Administration of the sIPV and DTaP or MMR

Condition(s) studied

Investigational drug(s) / intervention(s)

sIPV: Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose

DTaP: Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose

bOPV 1,3: Poliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose

MMR Vaccine: Measles, Mumps and Rubella Combined Live-attenuated Vaccine, 0.5mL for each dose

Study summary

This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and DTaP or MMR in infants aged 2 months. Primary immunogenicity endpoints in all groups include the seroconversion rate of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after basic immunization. Secondary immunogenicity endpoints include the seropositive rates, seroconversion rates, geometric mean titer/concentration (GMT/GMC), geometric mean fold increase (GMFI) of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies, and anti-measles, anti-mumps, and anti-rubella antibodies 30 days after full immunization. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.

Eligibility

Primary outcome measure(s)

• Immunogenicity index-seroconversion rate of type I anti-poliovirus neutrilizing antibody — Between baseline and day 30 after basic vaccination
  Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline
• Immunogenicity index-seroconversion rate of type II anti-poliovirus neutrilizing antibody — Between baseline and day 30 after basic vaccination
  Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline
• Immunogenicity index-seroconversion rate of type III anti-poliovirus neutrilizing antibody — Between baseline and day 30 after basic vaccination
  Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline
• Immunogenicity index-seroconversion rate of anti-DT antibody — Between baseline and day 30 after basic vaccination
  Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<0.1 IU/ml) to seropositive (Antibody Concentration≥0.1 IU/ml), or a ≥4-fold increase from baseline.
• Immunogenicity index-seroconversion rate of anti-TT antibody — Between baseline and day 30 after basic vaccination
  Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<0.1 IU/ml) to seropositive (Antibody Concentration≥0.1 IU/ml), or a ≥4-fold increase from baseline.
• Immunogenicity index-seroconversion rate of anti-PT antibody — Between baseline and day 30 after basic vaccination
  Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<20 IU/ml) to seropositive (Antibody Concentration≥20 IU/ml), or a ≥4-fold increase from baseline.
• Immunogenicity index-seroconversion rate of anti-FHA antibody — Between baseline and day 30 after basic vaccination
  Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<20 IU/ml) to seropositive (Antibody Concentration≥20 IU/ml), or a ≥4-fold increase from baseline.

Trial sites (9)

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