Evaluation of Safety and Immunogenicity of Combined Immunization of PPV23 and IIV4

Influenza, Human Clinical Trial

Official title:

A Multi-centered, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of Combined Immunization of 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) and Quadrivalent Inactivated Influenza Vaccine (IIV4)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559204
• Other study ID #: IIV4-PPV23
• Status: Completed
• Phase: Phase 4
• Start date: September 11, 2020
• Est. completion date: October 9, 2021

Study information

• Verified date: August 2022
• Source: China National Biotec Group Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subjects will be recruited and divided into 3 groups:

1. Experimental Group (408 subjects): combined immunization of PPV23 and IIV4;

2. Control Group A (408 subjects): IIV4 only;

3. Control Group B (408 subjects): PPV23 only;

All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.

Description:

To evaluate the safety and immunogenicity of simultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4) , we design this randomized, parallel controlled study . 1224 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B), each group includes 408 subjects respectively.

Each 408-subject group is divided again into 4 age-based subgroups: ① 3-8 years old; ② 9-18 years old; ③ 19-49 years old ; ④ over 50 years old; each subgroup includes 102 subjects respectively.

408 subjects from experimental group will be simultaneously administrated with one dose of IIV (0.5 ml) and one dose of PPV23 (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later.

408 subjects from control group A will be only administrated with one dose of IIV (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later.

408 subjects from control group B will be only administrated with one dose of PPV23 (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later.

To evaluate the immunogenicity, we will detect and compare the neutralization antibody levels, the seroprotection rates, and antibody geometric mean concentrations. The safety of all groups will be monitored as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1224
• Est. completion date: October 9, 2021
• Est. primary completion date: November 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• subjects aged no younger than 3 years old on the day of recruitment;

• with valid informed consent signed by parent(s) or guardian(s);

• parent(s) or guardian(s) are able to attend all scheduled appointments and comply with all study instructions;

• subjects have not received any seasonal influenza vaccine or pneumonia vaccine before;

• axillary temperature =37.0?

Exclusion Criteria:

• subject who has a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia or neurological illness;

• allergic to any ingredient of vaccine or with allergy history to any vaccine;

• subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(taking orally injecting of steroid hormone);

• administration of immunoglobulins within 30 days prior to this study;

• acute febrile disease(temperature = 37.0°C) or infectious disease;

• have a clearly diagnosed history of thrombocytopenia or other coagulopathy, which might cause contraindications for subcutaneous injection;

• any serious chronic illness, acute infectious diseases, or respiratory diseases; severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;

• any kind of infectious, purulent, or allergic skin diseases;

• pregnant women and breastfeeding women;

• inoculated with any vaccine within 14 days of the study;

• any other factor that makes the investigator determines the subject is unsuitable for this study.

Related Conditions & MeSH terms

• Influenza, Human
• Pneumonia, Pneumococcal

Intervention

Biological:
• IIV4 and PPV23
imultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4)
• IIV4
administrated with IIV4 only
• PPV23
administrated with PPV23 only

Locations

Country	Name	City	State
China	Qidong County Center for Disease Control and Prevention	Qidong	Hunan
China	Qingzhen Center for Disease Control and Prevention	Qingzhen	Guizhou
China	Liucheng Community Health Services Center	Quanzhou	Fujian
China	Luodong County Health Center	Quanzhou	Fujian

Sponsors (8)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Changchun Institute of Biological Products Co., Ltd., Chengdu Institute of Biological Products Co.,Ltd., Fujian Provincial Center for Disease Control and Prevention, Guizhou Center for Disease Control and Prevention, Hunan Provincial Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate (IIV4)	the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses	Baseline (before vaccination) results
Primary	Seroconversion rate (IIV4)	the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses	Results obtained 1 month after vaccination
Primary	Seroconversion rate (PPV23)	the rate of positive seroconversion against 23 pneumococcal serotypes	Baseline (before vaccination) results
Primary	Seroconversion rate (PPV23)	the rate of positive seroconversion against 23 pneumococcal serotypes	Results obtained 1 month after vaccination
Primary	Geometric Mean Concentration (GMC) (IIV4)	GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses	Baseline (before vaccination) results
Primary	Geometric Mean Concentration (GMC) (IIV4)	GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses	Results obtained 1 month after vaccination
Primary	Geometric Mean Concentration (GMC) (PPV23)	GMCs of 23 pneumococcal serotypes	Baseline (before vaccination) results
Primary	Geometric Mean Concentration (GMC) (PPV23)	GMCs of 23 pneumococcal serotypes	Results obtained 1 month after vaccination
Secondary	adverse events following vaccination	analyse the incidence of adverse events following immunization, both solicited and unsolicited	0-1 month (30 days)