NCT04559204

Brief Summary

Subjects will be recruited and divided into 3 groups:

  1. 1.Experimental Group (408 subjects): combined immunization of PPV23 and IIV4;
  2. 2.Control Group A (408 subjects): IIV4 only;
  3. 3.Control Group B (408 subjects): PPV23 only;

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,224

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

September 11, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2021

Completed
Last Updated

August 2, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

September 9, 2020

Last Update Submit

August 1, 2022

Conditions

Influenza, HumanPneumonia, Pneumococcal

Keywords

23-valent Pneumococcal Polysaccharide VaccineQuadrivalent Inactivated Influenza Vaccine

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (1)

  • adverse events following vaccination

    0-1 month (30 days)

Study Arms (3)

experimental group

EXPERIMENTAL

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

control group A

ACTIVE COMPARATOR

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

control group B

ACTIVE COMPARATOR

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

IIV4 and PPV23BIOLOGICAL

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

experimental group
IIV4BIOLOGICAL

administrated with IIV4 only

control group A
PPV23BIOLOGICAL

administrated with PPV23 only

control group B

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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℃

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Liucheng Community Health Services Center

Quanzhou, Fujian, 350001, China

Location

Luodong County Health Center

Quanzhou, Fujian, China

Location

Qingzhen Center for Disease Control and Prevention

Qingzhen, Guizhou, China

Location

Qidong County Center for Disease Control and Prevention

Hongqiao, Hunan, China

Location

MeSH Terms

Conditions

Influenza, HumanPneumonia, Pneumococcal

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumococcal InfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesPneumonia, BacterialPneumoniaLung Diseases

Study Officials

  • Shanying Zhang

    Center for Disease Control and Prevention, Fujian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 22, 2020

Study Start

September 11, 2020

Primary Completion

November 26, 2020

Study Completion

October 9, 2021

Last Updated

August 2, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)