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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05471531

Enrollment

3000

Registered

2022-07-25

Start date

2021-11-13

Completion date

2022-07-10

Last updated

2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza and Pneumonia

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.

Interventions

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

BIOLOGICALSeparate 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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