NCT05079152

Evaluation of Immunogenicity and Safety of Combined Immunization of COVAX (Produced in Wuhan) 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) (COVAX) (Produced in Wuhan) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) or Quadrivalent Inactivated Influenza Vaccine (IIV4)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,404 (actual)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
BIOLOGICAL	COVAX+PPV23;COVAX+IIV4	1st dose : combined vaccination of COVAX+PPV23; 2nd dose: combined vaccination of COVAX+IIV4
BIOLOGICAL	COVAX only (1st and 2nd dose)	1st dose: COVAX only; 2nd dose: COVAX only
BIOLOGICAL	PPV23 for the 1st dose and IIV4 for the 2nd dose	1st dose: PPV23 only; 2nd dose: IIV4 only

Timeline

• Start date: 2021-05-06
• Primary completion: 2021-05-29
• Completion: 2021-12-01
• First posted: 2021-10-15
• Last updated: 2021-10-15

Locations

3 sites across 1 country: China