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Completed

NCT Number: NCT04278248

Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above

The purpose of this study is to evaluate Immunogenicity and safety of 23-Valent Pneumococcal Polysaccharide Vaccine in healthy volunteers aged 2 Years and above.

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yizhou Center for Disease Control and Prevention

Yizhou, Guangxi, 530028, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 2 years old and above healthy people.
  • Subject or legal representative who consent and has signed written informed consent.
  • Subject or legal representative who is able to comply with all study procedures.
  • Subject who didn't vaccinate pneumococcal vaccines and did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
  • Axillary temperature ≤37.0 ℃.

Exclusion criteria

  • History of allergy,eclampsia, epilepsy, encephalopathy and mental disease or family disease.
  • Allergic history after vaccination.
  • Known allergy to any component of the test vaccine(the test vaccine mainly contains 23 types of pneumococcal polysaccharide and PBS buffer)
  • Subjects who diagnosis of thrombocytopenia or other history of coagulopathy.
  • Known immunological impairment or dysfunction.
  • Subjects who have received whole blood, plasma, and immunoglobulin therapy within one month.
  • Known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain Barre syndrome.
  • Known or suspected to suffer from: respiratory system disease,acute infection or chronic disease active period,severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease,children's mother has HIV infection and other serious and infectious diseases.
  • In pregnancy or lactation or pregnant women.
  • Subjects aged 18 years and above whose systolic blood pressure≥160mmHg and diastolic blood pressure≥100mmHg.
  • Any contraindications that investigators consider related to vaccination.

Treatment and study plan

23-valent pneumococcal polysaccharide vaccine

Biological

1 dose according to age of subjects. Single intramuscular dose contains 0.5ml 23-Valent Pneumococcal Polysaccharide Vaccine.

Primary outcomes

  1. Immunogenicity study endpoint

    Time frame: 30 day after each vaccination

    Percentage of participants with seroresponse to each vaccination

  2. Safety study endpoint

    Time frame: 30 day after each vaccination

    Occurrence of adverse events during a 30 day follow-up period after each vaccination

Sponsors and collaborators

Lead sponsor

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Randomized, Blinded, Parallel Controlled, Phase Ⅲ Clinical Trial to Evaluate Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2020
Registry last updated
Feb 20, 2020

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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