Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-30 @ 12:26 PM
Study NCT ID:
NCT04559204
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2020-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Immunogenicity of Combined Immunization of PPV23 and IIV4
Sponsor:
China National Biotec Group Company Limited
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: