Influenza, HumanPhase 4NCT05079152

Evaluation of Immunogenicity and Safety of Combined Immunization of COVAX (Produced in Wuhan) and PPV23 / IIV4

A Phase 4 study testing COVAX+PPV23;COVAX+IIV4, COVAX only (1st and 2nd dose) and PPV23 for the 1st dose and IIV4 for the 2nd dose in people with Influenza, Human and Pneumonia, Pneumococcal, run by China National Biotec Group Company Limited at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza, Human, Pneumonia, Pneumococcal, COVID-19 Pneumonia
What is being tested?: COVAX+PPV23;COVAX+IIV4, COVAX only (1st and 2nd dose) and PPV23 for the 1st dose and IIV4 for the 2nd dose
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,404 participants
Where: 3 sitesChina
Study dates: 6 May 2021to Dec 2021
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

≥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.

Who cannot join

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;

Show all 15Show fewer

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 a newly emerging condition that meets the exclusion criteria for the first dose;
Having any condition that may affect trial assessment as determined by researchers.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Guangdong Center for Disease Control and Prevention
Guangzhou, Guangdong
Hubei Center for Disease Control and Prevention
Wuhan, Hubei
Henan Center for Disease Control and Prevention
Zhengzhou, Henan

Other trials in China

About this study

Official title: A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Inactivated SARS-CoV-2 Vaccines (Vero Cell) (COVAX) (Produced in Wuhan) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) or Quadrivalent Inactivated Influenza Vaccine (IIV4)

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.

Read the detailed description

This randomized, parallel, controlled study is designed to evaluate the immunogenicity and safety of simultaneously immunization of COVAX + PPV23 and COVAX + IIV4.

1404 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B). Each group includes 468 subjects respectively.

Experimental Group (468 subjects) will receive: 1st dose : combined vaccination of COVAX+PPV23, 2nd dose: combined vaccination of COVAX+IIV4; Control Group A (468 subjects) will receive: 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (468 subjects) will receive: 1st dose: PPV23 only, 2nd dose: IIV4 only.

Specifically, each group will be divided again. Each 468-subject group is divided again into 2 age-based subgroups: (1) 18-59 years old; (2) ≥60 years old.

Each subgroup includes 234 subjects respectively. Blood samples will be collected 3 times: (1) before the 1st dose of vaccinatioin; (2) before the 2nd dose of vaccination; (3) 28 days after the 2nd dose of vaccination.

To evaluate the immunogenicity, the investigators will detect and compare the neutralizing antibody levels, the seroconversion rates and antibody geometric mean concentrations.

The safety of all groups will be monitored as well.

Conditions: Influenza, Human, Pneumonia, Pneumococcal, COVID-19 Pneumonia
Being tested: COVAX+PPV23;COVAX+IIV4, COVAX only (1st and 2nd dose), PPV23 for the 1st dose and IIV4 for the 2nd dose
Medical subject headings: Influenza, Human, Pneumonia, Pneumococcal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COVAX+PPV23;COVAX+IIV4Biological
1st dose : combined vaccination of COVAX+PPV23; 2nd dose: combined vaccination of COVAX+IIV4
COVAX only (1st and 2nd dose)Biological
1st dose: COVAX only; 2nd dose: COVAX only
PPV23 for the 1st dose and IIV4 for the 2nd doseBiological
1st dose: PPV23 only; 2nd dose: IIV4 only

Study groups in NCT05079152
Study group	Role	What they receive
Experimental group	Experimental	Experimental Group (468 subjects) will receive: 1st dose : combined vaccination of COVAX+PPV23; 2nd dose: combined vaccination of COVAX+IIV4 Receives: 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 Receives: 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 Receives: Biological: PPV23 for the 1st dose and IIV4 for the 2nd dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Seroconversion rate (COVAX)
the rate of positive seroconversion against coronavirus
Measured: Results obtained 28 days after the first dose (= right before the second dose)
Seroconversion rate (COVAX)
the rate of positive seroconversion against coronavirus
Measured: 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
Measured: Baseline (before vaccination) results
Neutralizing antibody level (COVAX)
neutralizing antibody level against coronavirus
Measured: Results obtained 28 days after the first dose (= right before the second dose)
Neutralizing antibody level (COVAX)
neutralizing antibody level against coronavirus
Measured: 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
Measured: Baseline (before vaccination) results
Seroconversion rate (IIV4)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (before vaccination) results
Neutralizing antibody level (PPV23)
Neutralizing antibody level against 23 pneumococcal serotypes
Measured: Results obtained 28 days after the first dose (= right before the second dose)
Neutralizing antibody level (PPV23)
Neutralizing antibody level against 23 pneumococcal serotypes
Measured: 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
analyse the incidence of adverse events following immunization, both solicited and unsolicited
Measured: 0-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 May 2021Dec 2021

First posted15 Oct 2021
Study start6 May 2021
Primary completion29 May 2021
Study completionDec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Influenza, HumanStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,404 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05079152
Sponsor's protocol ID: COVAX+PPV23+IIV4-Wuhan
Status last verified: Oct 2021
First submitted: 5 Oct 2021
Last updated: 15 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

All Influenza, Human trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Inactivated SARS-CoV-2 Vaccines (Vero Cell) (COVAX) (Produced in Wuhan) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) or Quadrivalent Inactivated Influenza Vaccine (IIV4)
ClinicalTrials.gov ID: NCT05079152
Acronym / sponsor ID: COVAX+PPV23+IIV4-Wuhan
Conditions: Influenza, Human, Pneumonia, Pneumococcal, COVID-19 Pneumonia
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,404 participants (actual)
Lead sponsor: China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
Collaborators: Chengdu Institute of Biological Products Co.,Ltd., Changchun Institute of Biological Products Co., Ltd., Wuhan Institute of Biological Products Co., Ltd, Hubei Provincial Center for Disease Control and Prevention, Guangdong Center for Disease Prevention and Control, Henan Center for Disease Control and Prevention
Study start: 6 May 2021 (actual)
Primary completion: 29 May 2021 (actual)
Study completion: Dec 2021 (estimated)
First posted: 15 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Subjects will be recruited and divided into 3 groups:

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.

Detailed description

This randomized, parallel, controlled study is designed to evaluate the immunogenicity and safety of simultaneously immunization of COVAX + PPV23 and COVAX + IIV4.

1404 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B). Each group includes 468 subjects respectively.

Specifically, each group will be divided again. Each 468-subject group is divided again into 2 age-based subgroups: (1) 18-59 years old; (2) ≥60 years old.

To evaluate the immunogenicity, the investigators will detect and compare the neutralizing antibody levels, the seroconversion rates and antibody geometric mean concentrations.

The safety of all groups will be monitored as well.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Experimental group	Experimental	Biological: COVAX+PPV23;COVAX+IIV4Experimental Group (468 subjects) will receive: 1st dose : combined vaccination of COVAX+PPV23; 2nd dose: combined vaccination of COVAX+IIV4
Control group A	Active comparator	Biological: COVAX only (1st and 2nd dose)Control Group A (468 subjects) will receive: 1st dose: COVAX only; 2nd dose: COVAX only
Control group B	Active comparator	Biological: PPV23 for the 1st dose and IIV4 for the 2nd doseControl Group B (468 subjects) will receive: 1st dose: PPV23 only; 2nd dose: IIV4 only

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

≥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;

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
COVAX+PPV23;COVAX+IIV41st dose : combined vaccination of COVAX+PPV23; 2nd dose: combined vaccination of COVAX+IIV4	Biological	Experimental group
COVAX only (1st and 2nd dose)1st dose: COVAX only; 2nd dose: COVAX only	Biological	Control group A
PPV23 for the 1st dose and IIV4 for the 2nd dose1st dose: PPV23 only; 2nd dose: IIV4 only	Biological	Control group B

Primary outcome

Seroconversion rate (COVAX)
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
the rate of positive seroconversion against coronavirus
Seroconversion rate (COVAX)
Time frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
the rate of positive seroconversion against coronavirus
Neutralizing antibody level (COVAX)
Time frame: Baseline (before vaccination) results
neutralizing antibody level against coronavirus
Neutralizing antibody level (COVAX)
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
neutralizing antibody level against coronavirus
Neutralizing antibody level (COVAX)
Time frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
neutralizing antibody level against coronavirus
Seropositive rate (IIV4)
Time frame: Baseline (before vaccination) results
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (IIV4)
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (IIV4)
Time frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Hemmagglution inhibition antibody level (IIV4)
Time frame: Baseline (before vaccination) results
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Hemmagglution inhibition antibody level (IIV4)
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Hemmagglution inhibition antibody level (IIV4)
Time frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (PPV23)
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
the rate of positive seroconversion against 23 pneumococcal serotypes
Seroconversion rate (PPV23)
Time frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
the rate of positive seroconversion against 23 pneumococcal serotypes
Neutralizing antibody level (PPV23)
Time frame: Baseline (before vaccination) results
Neutralizing antibody level against 23 pneumococcal serotypes
Neutralizing antibody level (PPV23)
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
Neutralizing antibody level against 23 pneumococcal serotypes
Neutralizing antibody level (PPV23)
Time frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Neutralizing antibody level against 23 pneumococcal serotypes

1 secondary outcome

Adverse events following vaccination
Time frame: 0-6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
Individual participant dataSharing planned: No

Related trials for Influenza, Human

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rate (COVAX) (time frame: Results obtained 28 days after the first dose (= right before the second dose)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05079152.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.