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Completed

NCT Number: NCT04700618

A Clinical Trial to Evaluate the Safety and Immunogenicity of PPV23 Vaccine Revaccinated in 60-70 Years Old

Objective: To evaluate the safety and immunogenicity of PPV23 vaccine revaccinated in 60-70 years old in Shanghai.

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Key information

Conditions

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai municipal center for disease control and prevention

Shanghai, Shanghai Municipality, China

About this study

  • Antibody double growth rate in 28-40 days after immunization;
  • Antibody GMC level in 28-40days after immunization;
  • Incidence of adverse reactions in 0-30days.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The age was 60-70 years old on the day of enrollment;
  • The subjects have signed the informed consent and signed the date;
  • The subjects are able to participate in all planned follow-up visits and were able to follow all trial procedures (e.g. complete diary card / contact card, return to visit);
  • The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years;
  • The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.

Exclusion criteria

  • With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
  • Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3.Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);

4.Administration of immunoglobulins within 30 days prior to this study; 5.Acute febrile disease(temperature ≥ 37.0°C) or infectious disease; 6.With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7.With any serious chronic illness, acute infectious diseases, or respiratory diseases; 8.Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes with complications; 9.With any kind of infectious, purulent, or allergic skin diseases; 10.With any other factor that makes the investigator determines the subject is unsuitable for this study.

Treatment and study plan

23-valent pneumococcal polysaccharide vaccine

Biological

The study group and the control group were vaccinated with one dose of vaccine and blood was collected after 28-40 days.

Primary outcomes

  1. Antibody doubling rate

    Time frame: The blood collection time was 28-40 days after vaccination.

    The difference of serum antibody double growth level between the two groups was compared.

Secondary outcomes

  1. Antibody GMC level

    Time frame: The blood collection time was 28-40 days after vaccination.

    The difference of serum antibody GMC level between the two groups was compared.

  2. Incidence of adverse reactions

    Time frame: Within 30 days after vaccination.

    Adverse reactions were collected during the observation period.

Sponsors and collaborators

Lead sponsor

China National Biotec Group Company Limited

Industry

Collaborators

  • Shanghai Municipal Center for Disease Control and Prevention

Registry information

Official study title

A Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of 23 Valent Pneumococcal Polysaccharide Vaccine Revaccinated in 60-70 Years Old in Shanghai

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 8, 2021
Registry last updated
Feb 16, 2022

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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