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Completed

NCT Number: NCT03902054

Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.

This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteer aged 2 months (60~90 days) old without prior vaccination of poliovirus and any contraindication for vaccination;
  • Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
  • Complying with the requirement of the study protocol;
  • Axillary temperature ≤ 37.0 °C;

Exclusion criteria

  • Preterm or low birth weight infants;
  • Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
  • History of polio;
  • Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
  • History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
  • Autoimmune disease or immunodeficiency/immunosuppressive;
  • Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
  • Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases;
  • Mother of the participant has HIV infection;
  • Acute illness or acute exacerbation of chronic disease within the past 7 days;
  • Had a high fever within the past 3 days (axillary temperature ≥ 38.0°C);
  • Receipt of any subunit or inactivated vaccine within the past 7 day;
  • Receipt of any live attenuated vaccine within the past 14 days;
  • Receipt of any blood product within the past 3 months;
  • Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;

Treatment and study plan

Three-dose regimen of high dosage investigational sIPV

Biological

The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..

Three-dose regimen of medium dosage investigational sIPV

Biological

The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..

Three-dose regimen of low dosage investigational sIPV

Biological

The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..

Three-dose regimen of commercialized sIPV

Biological

The control vaccine was manufactured by Chinese Academy of Medical Sciences.

Three-dose regimen of commercialized IPV

Biological

The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).

Primary outcomes

  1. The seroconversion rates (SCRs) of each group after three-dose regimen

    Time frame: 28~42 days

    Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.

  2. The post-immune geometric mean titer (GMT) of each group after three-dose regimen

    Time frame: 28~42 days

    GMT of each group 28~42 days after three-dose regimen.

  3. The geometric mean fold increase (GMI) of each group after three-dose regimen

    Time frame: 28~42 days

    The GMI is the increase of post-immune GMT from pre-immune GMT.

Secondary outcomes

  1. The incidences of solicited adverse events (AEs) of each group

    Time frame: 7 days

    Solicited AEs occurred within 7 days after each injection will be collected.

  2. The incidences of unsolicited adverse events (AEs) of each group

    Time frame: 30 days

    Unsolicited AEs occurred within 30 days after each injection will be collected.

  3. The incidences of serious adverse events (SAEs) of each group

    Time frame: 30 days

    SAEs occurred within 30 days after each injection will be collected.

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Collaborators

  • Beijing Minhai Biotechnology Co., Ltd

Registry information

Official study title

A Randomized, Blinded and Controlled Phase II Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Infants.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 3, 2019
Registry last updated
Apr 3, 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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