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CompletedNCT04559204Updated Aug 2, 2022

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

A Phase 4 interventional study of IIV4 and PPV23 and IIV4 in Influenza, Human and Pneumonia, Pneumococcal, sponsored by China National Biotec Group Company Limited. Completed at 4 sites in China. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-02.

Sponsored by China National Biotec Group Company Limited · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
1,224
Allocation
Randomized
Ages
3 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Influenza, Human
  • Pneumonia, Pneumococcal

Keywords

  • 23-valent Pneumococcal Polysaccharide Vaccine
  • Quadrivalent Inactivated Influenza Vaccine
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 1,224 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

China National Biotec Group Company Limited is the lead sponsor of 37 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,224 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • BiologicalIIV4 and PPV23

    imultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4)

  • BiologicalIIV4

    administrated with IIV4 only

  • BiologicalPPV23

    administrated with PPV23 only

06

What researchers measure

Primary outcomes

  1. Seroconversion rate (IIV4)

    the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses

    Time frame: Baseline (before vaccination) results

  2. Seroconversion rate (IIV4)

    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

  3. Seroconversion rate (PPV23)

    the rate of positive seroconversion against 23 pneumococcal serotypes

    Time frame: Baseline (before vaccination) results

  4. Seroconversion rate (PPV23)

    the rate of positive seroconversion against 23 pneumococcal serotypes

    Time frame: Results obtained 1 month after vaccination

  5. Geometric Mean Concentration (GMC) (IIV4)

    GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses

    Time frame: Baseline (before vaccination) results

  6. Geometric Mean Concentration (GMC) (IIV4)

    GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses

    Time frame: Results obtained 1 month after vaccination

  7. Geometric Mean Concentration (GMC) (PPV23)

    GMCs of 23 pneumococcal serotypes

    Time frame: Baseline (before vaccination) results

  8. Geometric Mean Concentration (GMC) (PPV23)

    GMCs of 23 pneumococcal serotypes

    Time frame: Results obtained 1 month after vaccination

Secondary outcomes

  1. adverse events following vaccination

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

    Time frame: 0-1 month (30 days)

07

Study locations

4 sites
  • Liucheng Community Health Services Center
    Quanzhou, Fujian 350001, China
  • Luodong County Health Center
    Quanzhou, Fujian, China
  • Qingzhen Center for Disease Control and Prevention
    Qingzhen, Guizhou, China
  • Qidong County Center for Disease Control and Prevention
    Qidong, Hunan, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04559204
Lead 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
Responsible party
Sponsor
First posted
Sep 22, 2020
Start date
Sep 11, 2020
Primary completion
Nov 26, 2020
Completion
Oct 9, 2021
Last update
Aug 2, 2022

Study contacts

Shanying Zhang
principal investigator · Center for Disease Control and Prevention, Fujian

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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