Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants

Polio Clinical Trial

Official title:

Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147560
• Other study ID #: ZJCDC20170508
• Status: Completed
• Phase: Phase 4
• Start date: May 2, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: September 2019
• Source: Zhejiang Provincial Center for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Days to 75 Days

Eligibility

Inclusion Criteria:

• Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.

• Participant is aged = 60 days to = 75 days.

• Participant without preventive inoculation of polio vaccine and previous history of Polio.

• Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.

• Body temperature = 37.5?.

Exclusion Criteria:

• Known allergy to any constituent of the vaccine.

• Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.

• Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.

• Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.

• Known bleeding disorder.

• Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.

• Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.

• An acute illness with or without fever (temperature = 38.0?) in the 3 days preceding enrollment in the trial.

• Participation in any other intervention clinical trial.

• Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.

Related Conditions & MeSH terms

• Polio

Intervention

Biological:
• Sabin IPV+ bOPV+ bOPV
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
• Sabin IPV + Sabin IPV + bOPV
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
• Sabin IPV + Sabin IPV + Sabin IPV
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.

Locations

Country	Name	City	State
China	Chunan Center for Disease Control and Prevention	Hangzhou	Zhejiang
China	Longyou Center for Disease Control and Prevention	Quzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang Provincial Center for Disease Control and Prevention	China National Biotec Group Company Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seroconversion rate	any positive antibody response in infants who were seronegative prior to their first dose, or at least a fourfold increase in type-specific antibody levels for infants who had pre-existing antibodies.	seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.
Secondary	safety: rate of adverse events	the rate of adverse events.	At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.
Secondary	neutralizing antibody titer		Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.