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NCT Number: NCT07648641

A Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)

This clinical study will enroll 100 participants from the 2-month-old (minimum 6 weeks) group who previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV), with 50 participants in each of the treatment and control groups, and who have completed blood sample collection for the 1-year and 2-year immunogenicity studies. All participants will have 3.0-3.5 mL of venous blood collected for the immunogenicity study.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

5 year–5 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants in the 2-month-old (minimum 6 weeks) group from the previous Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV)
  • The legal guardian or authorized representative is willing to provide identification documents
  • The legal guardian or authorized representative has provided informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol
  • The interval since the last dose of the primary vaccination series is ≥4 years

Exclusion criteria

  • Failure to complete blood draws at 1 and 2 years post-vaccination
  • Administration of any pneumonia vaccine after completion of the full vaccination series
  • Body temperature ≥37.3°C
  • Any other factors deemed by the investigator to render the participant unsuitable for participation in the clinical trial

Treatment and study plan

Previously vaccinated with PCV13 (CanSino)

Other

3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.

Previously vaccinated with PCV13 (Pfizer)

Other

3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.

Primary outcomes

  1. Seropositivity rate for serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml) among trial participants

    Time frame: 4 years after completion of the full vaccination series

  2. Geometric mean concentration (GMC) of antibodies among trial participants

    Time frame: 4 years after completion of the full vaccination series

Secondary outcomes

  1. Proportion of trial participants with serum-type-specific pneumococcal IgG antibody among trial participants

    Time frame: 4 years after completion of the full vaccination series

Study contacts

Contact information is provided by the study sponsor or research team.

Jiayi Huang

CONTACT

[email protected]

022-58213600-6051

Sponsors and collaborators

Lead sponsor

CanSino Biologics Inc.

Industry

Registry information

Official study title

Phase IV Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

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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