NCT05079152

Brief Summary

Subjects will be recruited and divided into 3 groups: Experimental Group (468 subjects): 1st dose : combined vaccination of COVAX+PPV23, 2nd dose: combined vaccination of COVAX+IIV4; Control Group A (468 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (468 subjects): 1st dose: PPV23 only, 2nd dose: IIV4 only. Blood samples will be collected 3 times: before the 1st dose of vaccinatioin; before the 2nd dose of vaccination; 28 days after the 2nd dose of vaccination. The immunogenicity and safety of both experimental and control groups will be analyzed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,404

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

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

Study Start

First participant enrolled

May 6, 2021

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

23 days

First QC Date

October 5, 2021

Last Update Submit

October 5, 2021

Conditions

Influenza, HumanPneumonia, PneumococcalCOVID-19 Pneumonia

Outcome Measures

Primary Outcomes (16)

  • Seroconversion rate (COVAX)

    the rate of positive seroconversion against coronavirus

    Results obtained 28 days after the first dose (= right before the second dose)

  • Seroconversion rate (COVAX)

    the rate of positive seroconversion against coronavirus

    Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)

  • Neutralizing antibody level (COVAX)

    neutralizing antibody level against coronavirus

    Baseline (before vaccination) results

  • Neutralizing antibody level (COVAX)

    neutralizing antibody level against coronavirus

    Results obtained 28 days after the first dose (= right before the second dose)

  • Neutralizing antibody level (COVAX)

    neutralizing antibody level against coronavirus

    Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)

  • Seropositive 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 28 days after the first dose (= right before the second dose)

  • Seroconversion rate (IIV4)

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

    Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)

  • Hemmagglution inhibition antibody level (IIV4)

    Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses

    Baseline (before vaccination) results

  • Hemmagglution inhibition antibody level (IIV4)

    Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses

    Results obtained 28 days after the first dose (= right before the second dose)

  • Hemmagglution inhibition antibody level (IIV4)

    Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses

    Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)

  • Seroconversion rate (PPV23)

    the rate of positive seroconversion against 23 pneumococcal serotypes

    Results obtained 28 days after the first dose (= right before the second dose)

  • Seroconversion rate (PPV23)

    the rate of positive seroconversion against 23 pneumococcal serotypes

    Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)

  • Neutralizing antibody level (PPV23)

    Neutralizing antibody level against 23 pneumococcal serotypes

    Baseline (before vaccination) results

  • Neutralizing antibody level (PPV23)

    Neutralizing antibody level against 23 pneumococcal serotypes

    Results obtained 28 days after the first dose (= right before the second dose)

  • Neutralizing antibody level (PPV23)

    Neutralizing antibody level against 23 pneumococcal serotypes

    Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)

Secondary Outcomes (1)

  • Adverse events following vaccination

    0-6 months

Study Arms (3)

Experimental group

EXPERIMENTAL

Experimental Group (468 subjects) will receive: 1st dose : combined vaccination of COVAX+PPV23; 2nd dose: combined vaccination of COVAX+IIV4

Biological: COVAX+PPV23;COVAX+IIV4

Control group A

ACTIVE COMPARATOR

Control Group A (468 subjects) will receive: 1st dose: COVAX only; 2nd dose: COVAX only

Biological: COVAX only (1st and 2nd dose)

Control group B

ACTIVE COMPARATOR

Control Group B (468 subjects) will receive: 1st dose: PPV23 only; 2nd dose: IIV4 only

Biological: PPV23 for the 1st dose and IIV4 for the 2nd dose

Interventions

COVAX+PPV23;COVAX+IIV4BIOLOGICAL

1st dose : combined vaccination of COVAX+PPV23; 2nd dose: combined vaccination of COVAX+IIV4

Experimental group
COVAX only (1st and 2nd dose)BIOLOGICAL

1st dose: COVAX only; 2nd dose: COVAX only

Control group A
PPV23 for the 1st dose and IIV4 for the 2nd doseBIOLOGICAL

1st dose: PPV23 only; 2nd dose: IIV4 only

Control group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years old when enrolled;
  • Participants signing the informed consent;
  • Being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview;
  • Having not been administered any pneumonia vaccine or COVID-19 vaccine, and having not been administered an influenza vaccine in the current season before enrollment;
  • ≥14 days from the most recent vaccination;
  • Before enrollment, the body temperature is ≤37.0C as confirmed by medical history and clinical examination.

You may not qualify if:

  • Having a history of COVID-19 or a positive nucleic acid test for COVID-19;
  • Having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness;
  • Being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine;
  • Having immunodeficiency disorder, during treatment of malignant tumor, having immunodeficiency induced by immunosuppressants (oral steroid hormones) or HIV, or having a family member with close contact who suffers from congenital immune disorder;
  • Having injection of non-specific immunoglobulin within 1 month prior to enrollment;
  • Having acute febrile illness or communicable disease;
  • Having a history of confirmed thrombocytopenia or other coagulation disorders, which may cause contraindications for a subcutaneous injection;
  • Having severe chronic disease or acute exacerbation of chronic disease, or having uncontrolled hypertension or diabetes;
  • Having various infectious, pyogenic, or allergic skin diseases;
  • Women in pregnancy or lactation or participants who plan for a baby within 3 months after vaccination should delay the vaccination;
  • Having any condition that may affect trial assessment as determined by researchers.
  • Having any serious adverse event related to the first dose vaccination;
  • After vaccination, having systemic adverse reaction or allergic reaction with a severity of grade 3 or higher as determined by researchers;
  • Having any condition that may affect trial assessment as determined by researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Guangdong Center for Disease Control and Prevention

Guangzhou, Guangdong, China

Location

Henan Center for Disease Control and Prevention

Zhengzhou, Henan, China

Location

Hubei Center for Disease Control and Prevention

Wuhan, Hubei, 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 Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Serum testing technicians were masked.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 15, 2021

Study Start

May 6, 2021

Primary Completion

May 29, 2021

Study Completion

December 1, 2021

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)