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Completed

NCT Number: NCT03147560

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

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.

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Key information

Age range

60 day–75 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chunan Center for Disease Control and Prevention, Hangzhou, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sabin IPV+ bOPV+ bOPV

Biological

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

Biological

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

Biological

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.

Primary outcomes

  1. seroconversion rate

    Time frame: seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.

    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.

Secondary outcomes

  1. safety: rate of adverse events

    Time frame: At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.

    the rate of adverse events.

  2. neutralizing antibody titer

    Time frame: Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial Center for Disease Control and Prevention

Other Gov

Collaborators

  • China National Biotec Group Company Limited

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 10, 2017
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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