Skip to main content
OpenTrials
Completed

NCT Number: NCT05471531

Study on Combined Vaccination With Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine

This study is an open-label,single center phase Ⅳ clinical trial of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.The purpose of this study is to evaluate the safety and immunogenicity of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in the elderly aged 60 years and above.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza and Pneumonia Infections Influenza, Human Lung Diseases Orthomyxoviridae Infections Pneumonia RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gaogang District Center for Disease Control and Prevention, Taizhou, Jiangsu, China

Loading trial locations.

About this study

This study is an open-label,single center,phase IV clinical trial in the elderly aged 60 Years and above.The experimental vaccines were manufactured by Sinovac Biotech Co., Ltd. A total of 3000 subjects will be enrolled,the safety and immunogenicity of combined immunization were evaluated in 480 subjects,and the Safety observation of combined immunization was evaluated in the extended safety group, which included 2520 subjects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The elderly aged 60 and above;
  • The subjects and/or guardians can understand and voluntarily sign the informed consent form;
  • Proven legal identity.

Exclusion criteria

  • Received any circulating seasonal influenza vaccine prior to enrollment;
  • Have received any pneumococcal vaccine within 5 years;
  • History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
  • History of uncontrolled epilepsy and other serious neurological disorders (e.g.transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.)
  • Fever,acute onset of chronic disease,severe uncontrolled chronic disease or acute disease at the time of vaccination;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Treatment and study plan

Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine

Biological

Quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine were manufactured by Sinovac Biotech Co., Ltd.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0.

Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine

Biological

Quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine were manufactured by Sinovac Biotech Co., Ltd.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0 and one dose of 23-valent pneumococcal polysaccharide vaccine on day 28 in subgroup 1,and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of quadrivalent influenza vaccine on day 28 in subgroup 2.

Primary outcomes

  1. Immunogenicity index of Geometric mean titer(GMT) of influenza HI antibodies

    Time frame: 28 days after combined vaccination

    GMT of influenza HI antibodies for each influenza strain at 28 days after combined vaccination .

Secondary outcomes

  1. Immunogenicity index of the seroconversion rates of influenza HI antibodies

    Time frame: 28 days after combined vaccination

    Seroconversion rate of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.

  2. Immunogenicity index of Geometric Mean Increase (GMI) of influenza HI antibodies

    Time frame: 28 days after combined vaccination

    GMI of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.

  3. Immunogenicity index of seropositivity rates of influenza HI antibodies

    Time frame: 28 days after combined vaccination

    Seropositivity rates of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.

  4. Immunogenicity index of Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody

    Time frame: 28 days after combined vaccination

    GMC for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.

  5. Immunogenicity index-seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody

    Time frame: 28 days after combined vaccination

    Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.

  6. Immunogenicity index-GMI for 23 serotypes specificity of pneumococcal IgG antibody

    Time frame: 28 days after combined vaccination

    GMI for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.

  7. Geometric mean titer(GMT) of influenza HI antibodies

    Time frame: 28 days after a single injection of quadrivalent influenza vaccine

    GMT of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.

  8. Seroconversion rates of influenza HI antibodies

    Time frame: 28 days after a single injection of quadrivalent influenza vaccine

    Seroconversion rates of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.

  9. Geometric Mean Increase (GMI) of influenza HI antibodies

    Time frame: 28 days after a single injection of quadrivalent influenza vaccine

    GMI of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.

  10. Seropositivity rates of influenza HI antibodies

    Time frame: 28 days after a single injection of quadrivalent influenza vaccine

    Seropositivity rates of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.

  11. Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody

    Time frame: 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine

    GMC for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.

  12. Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody

    Time frame: 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine

    Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.

  13. GMI for 23 serotypes specificity of pneumococcal IgG antibody

    Time frame: 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine

    GMI for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.

  14. Safety index-incidence of adverse reactions

    Time frame: Within 7 days after combined immunization

    Incidence of adverse reactions at 0~7 after combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.

  15. Safety index-Incidence of adverse reactions

    Time frame: Within 28 days after combined immunization

    Incidence of adverse reactions at 0~28 after combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.

  16. Incidence of adverse reactions after a single injection of quadrivalent influenza vaccine

    Time frame: Within 7 days after a single injection of quadrivalent influenza vaccine

    Incidence of adverse reactions at 0~7 after a single injection of quadrivalent influenza vaccine.

  17. The incidence of adverse reactions after a single injection of quadrivalent influenza vaccine

    Time frame: Within 28 days after a single injection of quadrivalent influenza vaccine

    Incidence of adverse reactions at 0~28 after a single injection of quadrivalent influenza vaccine.

  18. Incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine

    Time frame: Within 7 days after a single injection of 23-valent pneumococcal polysaccharide vaccine

    Incidence of adverse reactions at 0~7 after a single injection of 23-valent pneumococcal polysaccharide vaccine.

  19. The incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine

    Time frame: Within 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine

    Incidence of adverse reactions at 0~28 after a single injection of 23-valent pneumococcal polysaccharide vaccine.

Sponsors and collaborators

Lead sponsor

Sinovac Biotech Co., Ltd

Industry

Registry information

Official study title

Immunogenicity and Safety of Quadrivalent Influenza Vaccine Combined Immunization With 23-valent Pneumococcal Polysaccharide Vaccine in the Elderly Aged 60 Years and Above

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 25, 2022
Registry last updated
Jul 25, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.