NCT04559204

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,224 (actual)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

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. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.

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

Interventions

Type	Name	Description
BIOLOGICAL	IIV4 and PPV23	imultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4)
BIOLOGICAL	IIV4	administrated with IIV4 only
BIOLOGICAL	PPV23	administrated with PPV23 only

Timeline

• Start date: 2020-09-11
• Primary completion: 2020-11-26
• Completion: 2021-10-09
• First posted: 2020-09-22
• Last updated: 2022-08-02

Locations

4 sites across 1 country: China