CompletedNCT04790851Updated Oct 20, 2021

Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4

A Phase 4 interventional study of COVAX+IIV4; COVAX+PPV23 and COVAX only (1st and 2nd dose) in Influenza, Human, Pneumonia, Pneumococcal and Covid19, sponsored by China National Biotec Group Company Limited. Completed at 3 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-20.

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

Phase: Phase 4
Study type: Interventional
Enrollment: 1,133
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Subjects will be recruited and divided into 3 groups:

Experimental Group (384 subjects): 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects): 1st dose: IIV4 only, 2nd dose: PPV23 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.

1152 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B). Each group includes 384 subjects respectively.

Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects) will receive: 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects) will receive: 1st dose: IIV4 only, 2nd dose: PPV23 only.

Specifically, each group will be divided again. Each 384-subject group is divided again into 2 age-based subgroups: (1) 18-59 years old; (2) ≥60 years old.

Each subgroup includes 192 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 studied

Influenza, Human
Pneumonia, Pneumococcal
Covid19

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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 1,133 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

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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.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

Inclusion criteria:

≥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.

Exclusion criteria for the first dose:

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.

Exclusion criteria for the second dose:

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.

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 1,133 participants (actual)

Study arms

Experimental
Experimental group
Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23
Biological: COVAX+IIV4; COVAX+PPV23
Active comparator
Control group A
Control Group A (384 subjects) will receive: 1st dose: COVAX only; 2nd dose: COVAX only
Biological: COVAX only (1st and 2nd dose)
Active comparator
Control group B
Control Group B (384 subjects) will receive: 1st dose: IIV4 only; 2nd dose: PPV23 only
Biological: IIV4 for the 1st dose and PPV23 for the 2nd dose

Interventions

BiologicalCOVAX+IIV4; COVAX+PPV23
1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23
BiologicalCOVAX only (1st and 2nd dose)
1st dose: COVAX only; 2nd dose: COVAX only
BiologicalIIV4 for the 1st dose and PPV23 for the 2nd dose
1st dose: IIV4 only; 2nd dose: PPV23 only

What researchers measure

Primary outcomes

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

Secondary outcomes

Adverse events following vaccination
analyse the incidence of adverse events following immunization, both solicited and unsolicited
Time frame: 0-6 months

Study locations

3 sites

Sichuan Center for Disease Control and Prevention
Chengdu, 610041, China
Shanghai Municipal Center for Disease Control and Prevention
Shanghai, 200336, China
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan, 030012, China

References and documents

Publications

Chen H, Huang Z, Chang S, Hu M, Lu Q, Zhang Y, Wang H, Xiao Y, Wang H, Ge Y, Zou Y, Cui F, Han S, Zhang M, Wang S, Zhu X, Zhang B, Li Z, Ren J, Chen X, Ma R, Zhang L, Guo X, Luo L, Sun X, Yang X. Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (Sinopharm BBIBP-CorV) coadministered with quadrivalent split-virion inactivated influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in China: A multicentre, non-inferiority, open-label, randomised, controlled, phase 4 trial. Vaccine. 2022 Aug 26;40(36):5322-5332. doi: 10.1016/j.vaccine.2022.07.033. Epub 2022 Jul 29. PubMed 35931636 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04790851
Lead sponsor: China National Biotec Group Company Limited
Collaborators: Chengdu Institute of Biological Products Co.,Ltd., Changchun Institute of Biological Products Co., Ltd., Beijing Institute of Biological Products Co Ltd., Sichuan Center for Disease Control and Prevention, Shanghai Municipal Center for Disease Control and Prevention, Shanxi Center for Disease Control and Prevention
Responsible party: Sponsor
First posted: Mar 10, 2021
Start date: Mar 10, 2021
Primary completion: Sep 5, 2021
Completion: Sep 5, 2021
Last update: Oct 20, 2021

Study contacts

Xiaodong Sun

principal investigator · Shanghai Municipal Center for Disease Control and Prevention

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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