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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza and Pneumonia
• Intervention / Treatment: Biological: Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine; Biological: Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 3000
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Taizhou, Jiangsu, China, 214527
      • Jingjiang Center for Diseases Control and Prevention
    • Taizhou, Jiangsu, China, 225309
      • Taizhou City Hospital of Traditional Chinese and Western Medicine
    • Taizhou, Jiangsu, China, 225323
      • Gaogang District Center for Disease Control and Prevention
    • Taizhou, Jiangsu, China, 225799
      • Xinghua Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined immunization group; 160 subjects received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0.	Biological: Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine; 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.
Experimental: Non combined immunization group; 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.	Biological: Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine; 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.
Experimental: Safety group; 2520 subjects were enrolled and received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0.	Biological: Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	28 days after combined vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Within 7 days after combined immunization
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.	Within 28 days after combined immunization
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.	Within 7 days 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.	Within 28 days 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.	Within 7 days 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.	Within 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd
• Investigators: Principal Investigator: Zhongkui Zhu, Master, Taizhou Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2021
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): July 10, 2022

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: PRO-INF4-MA4002-JStz

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No