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

Primary Purpose

Influenza, Human, Pneumonia, Pneumococcal

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
IIV4 and PPV23
IIV4
PPV23
Sponsored by
China National Biotec Group Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring 23-valent Pneumococcal Polysaccharide Vaccine, Quadrivalent Inactivated Influenza Vaccine

Eligibility Criteria

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

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.

Sites / Locations

  • Liucheng Community Health Services Center
  • Luodong County Health Center
  • Qingzhen Center for Disease Control and Prevention
  • Qidong County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

experimental group

control group A

control group B

Arm Description

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.

Outcomes

Primary Outcome Measures

Seroconversion rate (IIV4)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (IIV4)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (PPV23)
the rate of positive seroconversion against 23 pneumococcal serotypes
Seroconversion rate (PPV23)
the rate of positive seroconversion against 23 pneumococcal serotypes
Geometric Mean Concentration (GMC) (IIV4)
GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Geometric Mean Concentration (GMC) (IIV4)
GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Geometric Mean Concentration (GMC) (PPV23)
GMCs of 23 pneumococcal serotypes
Geometric Mean Concentration (GMC) (PPV23)
GMCs of 23 pneumococcal serotypes

Secondary Outcome Measures

adverse events following vaccination
analyse the incidence of adverse events following immunization, both solicited and unsolicited

Full Information

First Posted
September 9, 2020
Last Updated
August 1, 2022
Sponsor
China National Biotec Group Company Limited
Collaborators
Center for Disease Control and Prevention, Fujian, Chengdu Institute of Biological Products Co.,Ltd., Changchun Institute of Biological Products Co., Ltd., National Institutes for Food and Drug Control, China, Guizhou Center for Disease Control and Prevention, Hunan Provincial Center for Disease Control and Prevention, Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT04559204
Brief Title
Evaluation of Safety and Immunogenicity of Combined Immunization of PPV23 and IIV4
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
November 26, 2020 (Actual)
Study Completion Date
October 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Biotec Group Company Limited
Collaborators
Center for Disease Control and Prevention, Fujian, Chengdu Institute of Biological Products Co.,Ltd., Changchun Institute of Biological Products Co., Ltd., National Institutes for Food and Drug Control, China, Guizhou Center for Disease Control and Prevention, Hunan Provincial Center for Disease Control and Prevention, Peking University

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
Subjects will be recruited and divided into 3 groups: Experimental Group (408 subjects): combined immunization of PPV23 and IIV4; Control Group A (408 subjects): IIV4 only; 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Pneumonia, Pneumococcal
Keywords
23-valent Pneumococcal Polysaccharide Vaccine, Quadrivalent Inactivated Influenza Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
IIV4 and PPV23
Intervention Description
imultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4)
Intervention Type
Biological
Intervention Name(s)
IIV4
Intervention Description
administrated with IIV4 only
Intervention Type
Biological
Intervention Name(s)
PPV23
Intervention Description
administrated with PPV23 only
Primary Outcome Measure Information:
Title
Seroconversion rate (IIV4)
Description
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time Frame
Baseline (before vaccination) results
Title
Seroconversion rate (IIV4)
Description
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time Frame
Results obtained 1 month after vaccination
Title
Seroconversion rate (PPV23)
Description
the rate of positive seroconversion against 23 pneumococcal serotypes
Time Frame
Baseline (before vaccination) results
Title
Seroconversion rate (PPV23)
Description
the rate of positive seroconversion against 23 pneumococcal serotypes
Time Frame
Results obtained 1 month after vaccination
Title
Geometric Mean Concentration (GMC) (IIV4)
Description
GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time Frame
Baseline (before vaccination) results
Title
Geometric Mean Concentration (GMC) (IIV4)
Description
GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time Frame
Results obtained 1 month after vaccination
Title
Geometric Mean Concentration (GMC) (PPV23)
Description
GMCs of 23 pneumococcal serotypes
Time Frame
Baseline (before vaccination) results
Title
Geometric Mean Concentration (GMC) (PPV23)
Description
GMCs of 23 pneumococcal serotypes
Time Frame
Results obtained 1 month after vaccination
Secondary Outcome Measure Information:
Title
adverse events following vaccination
Description
analyse the incidence of adverse events following immunization, both solicited and unsolicited
Time Frame
0-1 month (30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shanying Zhang
Organizational Affiliation
Center for Disease Control and Prevention, Fujian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liucheng Community Health Services Center
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Luodong County Health Center
City
Quanzhou
State/Province
Fujian
Country
China
Facility Name
Qingzhen Center for Disease Control and Prevention
City
Qingzhen
State/Province
Guizhou
Country
China
Facility Name
Qidong County Center for Disease Control and Prevention
City
Qidong
State/Province
Hunan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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