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

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)

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Pneumococcal; Influenza, Human
• Intervention / Treatment: Biological: IIV4 and PPV23; Biological: IIV4; Biological: PPV23

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.

• Study Type: Interventional
• Enrollment (Actual): 1224
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Fujian
    • Quanzhou, Fujian, China, 350001
      • Liucheng Community Health Services Center
    • Quanzhou, Fujian, China
      • Luodong County Health Center
  • Guizhou
    • Qingzhen, Guizhou, China
      • Qingzhen Center for Disease Control and Prevention
  • Hunan
    • Qidong, Hunan, China
      • Qidong County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; 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.	Biological: IIV4 and PPV23; imultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4)
Active Comparator: control group A; 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.	Biological: IIV4; administrated with IIV4 only
Active Comparator: control group B; 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.	Biological: PPV23; administrated with PPV23 only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rate (IIV4)	the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses	Baseline (before vaccination) results
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
Seroconversion rate (PPV23)	the rate of positive seroconversion against 23 pneumococcal serotypes	Baseline (before vaccination) results
Seroconversion rate (PPV23)	the rate of positive seroconversion against 23 pneumococcal serotypes	Results obtained 1 month after vaccination
Geometric Mean Concentration (GMC) (IIV4)	GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses	Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (IIV4)	GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses	Results obtained 1 month after vaccination
Geometric Mean Concentration (GMC) (PPV23)	GMCs of 23 pneumococcal serotypes	Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (PPV23)	GMCs of 23 pneumococcal serotypes	Results obtained 1 month after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events following vaccination	analyse the incidence of adverse events following immunization, both solicited and unsolicited	0-1 month (30 days)

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Peking University; Hunan Provincial Center for Disease Control and Prevention; Guizhou Center for Disease Control and Prevention; National Institutes for Food and Drug Control, China; Fujian Provincial Center for Disease Control and Prevention; Chengdu Institute of Biological Products Co.,Ltd.; Changchun Institute of Biological Products Co., Ltd.
• Investigators: Principal Investigator: Shanying Zhang, Fujian Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Actual): November 26, 2020
• Study Completion (Actual): October 9, 2021

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 20, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: 23-valent Pneumococcal Polysaccharide Vaccine; Quadrivalent Inactivated Influenza Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Orthomyxoviridae Infections; Pneumococcal Infections; Pneumonia, Pneumococcal; Influenza, Human
• Other Study ID Numbers: IIV4-PPV23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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