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Canceled by the investigator Evaluation of Immunogenicity and Safety of Combined Immunization of COVIV and PPV23 / IIV4

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) (COVIV) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) or Quadrivalent Inactivated Influenza Vaccine (IIV4)

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046174
Enrollment
Unknown
Registered
2021-05-08
Start date
2021-05-12
Completion date
Unknown
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Human, Pneumonia, Pneumococcal, Covid19

Interventions

Experimental group:1st dose: combined vaccination of COVIV+IIV4
2nd dose: combined vaccination of COVIV+PPV23
Control group A:1st dose: COVIV only
Control group B:1st dose: IIV4 only
2nd dose: PPV23 only

Sponsors

Shanghai Municipal Center for Disease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old when enrolled; 2. Participants signing the informed consent; 3. Being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview; 4. 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; 5. >=14 days from the most recent vaccination; 6. Before enrollment, the body temperature <=37.0 degree C as confirmed by medical history and clinical examination.

Exclusion criteria

Exclusion criteria: 1. Having a history of COVID-19 or a positive nucleic acid test for COVID-19; 2. Having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness; 3. Being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine; 4. 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; 5. Having injection of non-specific immunoglobulin within 1 month prior to enrollment; 6. Having acute febrile illness or communicable disease; 7. Having a history of confirmed thrombocytopenia or other coagulation disorders, which may cause contraindications for a subcutaneous injection; 8. Having severe chronic disease or acute exacerbation of chronic disease, or having uncontrolled hypertension or diabetes; 9. Having various infectious, pyogenic, or allergic skin diseases; 10. Women in pregnancy or lactation or participants who plan for a baby within 3 months after vaccination should delay the vaccination; 11. Having any condition that may affect trial assessment as determined by researchers.

Design outcomes

Primary

MeasureTime frame
Seroconversion rate;Antibody positive rate ;Neutralizing antibody level;

Secondary

MeasureTime frame
Adverse reaction;

Countries

China

Contacts

Public ContactXiaodong Sun

Shanghai Municipal Center for Disease Control and Prevention

sunxiaodong@scdc.sh.cn+86 21 62758710

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026