Influenza, HumanPhase 4NCT04559204

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

A Phase 4 study testing IIV4 and PPV23, IIV4 and PPV23 in people with Influenza, Human and Pneumonia, Pneumococcal, run by China National Biotec Group Company Limited at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 3 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza, Human, Pneumonia, Pneumococcal
What is being tested?: IIV4 and PPV23, IIV4 and PPV23
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,224 participants
Where: 4 sitesChina
Study dates: 11 Sep 2020to 9 Oct 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 3 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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℃

Who cannot join

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;

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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.

Trial locations and contacts

4 sites in 1 country.

China4 sites

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

Other trials in China

About this study

Official title: 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:

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

Conditions: Influenza, Human, Pneumonia, Pneumococcal
Being tested: IIV4 and PPV23, IIV4, PPV23
Keywords: 23-valent Pneumococcal Polysaccharide Vaccine, Quadrivalent Inactivated Influenza Vaccine
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.

IIV4 and PPV23Biological
imultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4)
IIV4Biological
administrated with IIV4 only
PPV23Biological
administrated with PPV23 only

Study groups in NCT04559204
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Biological: PPV23

What is being measured

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

Seroconversion 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 1 month after vaccination
Seroconversion rate (PPV23)
the rate of positive seroconversion against 23 pneumococcal serotypes
Measured: Baseline (before vaccination) results
Seroconversion rate (PPV23)
the rate of positive seroconversion against 23 pneumococcal serotypes
Measured: Results obtained 1 month after vaccination
Geometric Mean Concentration (GMC) (IIV4)
GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Measured: Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (IIV4)
GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Measured: Results obtained 1 month after vaccination
Geometric Mean Concentration (GMC) (PPV23)
GMCs of 23 pneumococcal serotypes
Measured: Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (PPV23)
GMCs of 23 pneumococcal serotypes
Measured: 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
Measured: 0-1 month (30 days)

Timeline

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

11 Sep 20209 Oct 2021

First posted22 Sep 2020
Study start11 Sep 2020
Primary completion26 Nov 2020
Study completion9 Oct 2021

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: 1,224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04559204
Sponsor's protocol ID: IIV4-PPV23
Status last verified: Aug 2022
First submitted: 9 Sep 2020
Last updated: 2 Aug 2022
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

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Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT04559204
Acronym / sponsor ID: IIV4-PPV23
Conditions: Influenza, Human, Pneumonia, Pneumococcal
Keywords: 23-valent Pneumococcal Polysaccharide Vaccine, Quadrivalent Inactivated Influenza Vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,224 participants (actual)
Lead sponsor: China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
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
Study start: 11 Sep 2020 (actual)
Primary completion: 26 Nov 2020 (actual)
Study completion: 9 Oct 2021 (actual)
First posted: 22 Sep 2020 (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:

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

Detailed description

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.

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: IIV4 and PPV23408 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.
control group A	Active comparator	Biological: IIV4408 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.
control group B	Active comparator	Biological: PPV23408 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.

Who may qualify

Ages: 3 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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℃

Key exclusion criteria (11 listed)

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;

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
IIV4 and PPV23imultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4)	Biological	experimental group
IIV4administrated with IIV4 only	Biological	control group A
PPV23administrated with PPV23 only	Biological	control group B

Primary outcome

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

1 secondary outcome

adverse events following vaccination
Time frame: 0-1 month (30 days)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
Individual participant dataSharing planned: No

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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.

Shanying Zhang principal investigator

Center for Disease Control and Prevention, Fujian

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing IIV4 and PPV23, IIV4 and PPV23 in people with Influenza, Human and Pneumonia, Pneumococcal, run by China National Biotec Group Company Limited at 4 sites in China.

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 5 inclusion and 11 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: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (IIV4) (time frame: Baseline (before vaccination) results). The study lists 8 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 NCT04559204.

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 2 Aug 2022.