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

Primary Purpose

Influenza and Pneumonia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine
Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza and Pneumonia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Jingjiang Center for Diseases Control and Prevention
  • Taizhou City Hospital of Traditional Chinese and Western Medicine
  • Gaogang District Center for Disease Control and Prevention
  • Xinghua Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Combined immunization group

Non combined immunization group

Safety group

Arm Description

160 subjects received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0.

There were two subgroups in non combined immunization group,and 160 subjects in each subgroup.The non combined immunization subgroup 1 received one dose of quadrivalent influenza vaccine on day 0 and one dose of 23-valent pneumococcal polysaccharide vaccine on day 28.The non combined immunization subgroup 2 received one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of quadrivalent influenza vaccine on day 28.

2520 subjects were enrolled and received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0.

Outcomes

Primary Outcome Measures

Immunogenicity index of Geometric mean titer(GMT) of influenza HI antibodies
GMT of influenza HI antibodies for each influenza strain at 28 days after combined vaccination .

Secondary Outcome Measures

Immunogenicity index of the seroconversion rates of influenza HI antibodies
Seroconversion rate of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.
Immunogenicity index of Geometric Mean Increase (GMI) of influenza HI antibodies
GMI of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.
Immunogenicity index of seropositivity rates of influenza HI antibodies
Seropositivity rates of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.
Immunogenicity index of Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody
GMC for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.
Immunogenicity index-seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody
Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.
Immunogenicity index-GMI for 23 serotypes specificity of pneumococcal IgG antibody
GMI for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.
Geometric mean titer(GMT) of influenza HI antibodies
GMT of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Seroconversion rates of influenza HI antibodies
Seroconversion rates of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Geometric Mean Increase (GMI) of influenza HI antibodies
GMI of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Seropositivity rates of influenza HI antibodies
Seropositivity rates of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody
GMC for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody
Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.
GMI for 23 serotypes specificity of pneumococcal IgG antibody
GMI for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Safety index-incidence of adverse reactions
Incidence of adverse reactions at 0~7 after combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.
Safety index-Incidence of adverse reactions
Incidence of adverse reactions at 0~28 after combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.
Incidence of adverse reactions after a single injection of quadrivalent influenza vaccine
Incidence of adverse reactions at 0~7 after a single injection of quadrivalent influenza vaccine.
The incidence of adverse reactions after a single injection of quadrivalent influenza vaccine
Incidence of adverse reactions at 0~28 after a single injection of quadrivalent influenza vaccine.
Incidence of adverse reactions 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.
The incidence of adverse reactions 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.

Full Information

First Posted
July 13, 2022
Last Updated
July 20, 2022
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05471531
Brief Title
Study on Combined Vaccination With Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine
Official Title
Immunogenicity and Safety of Quadrivalent Influenza Vaccine Combined Immunization With 23-valent Pneumococcal Polysaccharide Vaccine in the Elderly Aged 60 Years and Above
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 13, 2021 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
July 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza and Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined immunization group
Arm Type
Experimental
Arm Description
160 subjects received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0.
Arm Title
Non combined immunization group
Arm Type
Experimental
Arm Description
There were two subgroups in non combined immunization group,and 160 subjects in each subgroup.The non combined immunization subgroup 1 received one dose of quadrivalent influenza vaccine on day 0 and one dose of 23-valent pneumococcal polysaccharide vaccine on day 28.The non combined immunization subgroup 2 received one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of quadrivalent influenza vaccine on day 28.
Arm Title
Safety group
Arm Type
Experimental
Arm Description
2520 subjects were enrolled and received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0.
Intervention Type
Biological
Intervention Name(s)
Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine
Intervention Description
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 Outcome Measure Information:
Title
Immunogenicity index of Geometric mean titer(GMT) of influenza HI antibodies
Description
GMT of influenza HI antibodies for each influenza strain at 28 days after combined vaccination .
Time Frame
28 days after combined vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity index of the seroconversion rates of influenza HI antibodies
Description
Seroconversion rate of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.
Time Frame
28 days after combined vaccination
Title
Immunogenicity index of Geometric Mean Increase (GMI) of influenza HI antibodies
Description
GMI of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.
Time Frame
28 days after combined vaccination
Title
Immunogenicity index of seropositivity rates of influenza HI antibodies
Description
Seropositivity rates of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.
Time Frame
28 days after combined vaccination
Title
Immunogenicity index of Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody
Description
GMC for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.
Time Frame
28 days after combined vaccination
Title
Immunogenicity index-seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody
Description
Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.
Time Frame
28 days after combined vaccination
Title
Immunogenicity index-GMI for 23 serotypes specificity of pneumococcal IgG antibody
Description
GMI for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.
Time Frame
28 days after combined vaccination
Title
Geometric mean titer(GMT) of influenza HI antibodies
Description
GMT of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Time Frame
28 days after a single injection of quadrivalent influenza vaccine
Title
Seroconversion rates of influenza HI antibodies
Description
Seroconversion rates of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Time Frame
28 days after a single injection of quadrivalent influenza vaccine
Title
Geometric Mean Increase (GMI) of influenza HI antibodies
Description
GMI of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Time Frame
28 days after a single injection of quadrivalent influenza vaccine
Title
Seropositivity rates of influenza HI antibodies
Description
Seropositivity rates of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Time Frame
28 days after a single injection of quadrivalent influenza vaccine
Title
Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody
Description
GMC for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Time Frame
28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
Title
Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody
Description
Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Time Frame
28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
Title
GMI for 23 serotypes specificity of pneumococcal IgG antibody
Description
GMI for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Time Frame
28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
Title
Safety index-incidence of adverse reactions
Description
Incidence of adverse reactions at 0~7 after combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.
Time Frame
Within 7 days after combined immunization
Title
Safety index-Incidence of adverse reactions
Description
Incidence of adverse reactions at 0~28 after combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.
Time Frame
Within 28 days after combined immunization
Title
Incidence of adverse reactions after a single injection of quadrivalent influenza vaccine
Description
Incidence of adverse reactions at 0~7 after a single injection of quadrivalent influenza vaccine.
Time Frame
Within 7 days after a single injection of quadrivalent influenza vaccine
Title
The incidence of adverse reactions after a single injection of quadrivalent influenza vaccine
Description
Incidence of adverse reactions at 0~28 after a single injection of quadrivalent influenza vaccine.
Time Frame
Within 28 days after a single injection of quadrivalent influenza vaccine
Title
Incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine
Description
Incidence of adverse reactions at 0~7 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
Title
The incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine
Description
Incidence of adverse reactions at 0~28 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongkui Zhu, Master
Organizational Affiliation
Taizhou Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jingjiang Center for Diseases Control and Prevention
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
214527
Country
China
Facility Name
Taizhou City Hospital of Traditional Chinese and Western Medicine
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225309
Country
China
Facility Name
Gaogang District Center for Disease Control and Prevention
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225323
Country
China
Facility Name
Xinghua Center for Disease Control and Prevention
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225799
Country
China

12. IPD Sharing Statement

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

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