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Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23 (QIV;PPV23)

Primary Purpose

Safety, Immunogenicity, Vaccine, COVID-19 Vaccines

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Vaccine
Sponsored by
Centers for Disease Control and Prevention, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Safety focused on measuring Safety;Immunogenecity;Combined Immunization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults 18 years old and older
  • Over 6 months after primary immunization with COVID-19 vaccines
  • Can understand and sign the consent
  • Can provide effective personal identification

Exclusion Criteria:

  • Has a history of COVID-19 infection
  • Less than 6 months after primary immunization with COVID-19 vaccines
  • Already vaccinated with influenza vaccines of that year
  • Vaccinated with pneumococcal vaccines within 5 years
  • Has a history of severe hypersensitivity reaction to vaccines
  • Has uncontrolled seizure or other severe neural system illnesses
  • Has a fever, chronic disease, or acute disease during immunization
  • Gestation period, lactation period, or planning to get pregnant within 3 months
  • Administrated with other drugs under research within 30 days before vaccination
  • Received attenuated vaccines within 14 days before vaccination
  • Received subunit vaccines or inactivated vaccines within 7 days before vaccination
  • Other conditions based on researcher's judgement

Sites / Locations

  • Daxing District Center of Disease Control and PreventionRecruiting
  • Huairou District Center of Disease Control and PreventionRecruiting
  • Miyun District Center of Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

COVID-19 and QIV

COVID-19 and PPV23

COVID-19

Arm Description

Outcomes

Primary Outcome Measures

Seroconversion rate of neutralizing antibody

Secondary Outcome Measures

Full Information

First Posted
March 18, 2022
Last Updated
March 24, 2022
Sponsor
Centers for Disease Control and Prevention, China
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1. Study Identification

Unique Protocol Identification Number
NCT05298800
Brief Title
Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23
Acronym
QIV;PPV23
Official Title
Clinical Observation of Combined Immunization of COVID-19 Inactivated Vaccine With Quadrivalent Influenza Vaccine(QIV) and 23-valent Pneumococcal Polysaccharide Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centers for Disease Control and Prevention, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study was to evaluate the immunogenicity and safety of the booster dose of COVID-19 inactivated vaccine and co-immunization with quadrivalent influenza vaccine and 23-valent pneumonia polysaccharide vaccine in people aged 18 years and older. A randomized controlled, open trial design was adopted. The study was conducted with informed consent of the subjects for immunogenicity and safety in the population aged 18 years and older. A total of 3000 healthy subjects were selected, (1)600 healthy subjects were selected for the immunogenicity and safety study of co-immunization, 300 in the adult group (18-59 years old) and 300 in the elderly group (60 years old and above); (2) 2400 healthy subjects were selected for the observational study of the safety of co-immunization, 1200 in the adult group (18-59 years old) and 1200 in the elderly group (60 years old and above ) 1200 people.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety, Immunogenicity, Vaccine, COVID-19 Vaccines, Influenza Vaccines, Pneumococcal Vaccines
Keywords
Safety;Immunogenecity;Combined Immunization

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 and QIV
Arm Type
Experimental
Arm Title
COVID-19 and PPV23
Arm Type
Experimental
Arm Title
COVID-19
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Vaccine
Intervention Description
Different arms were administrated different vaccines
Primary Outcome Measure Information:
Title
Seroconversion rate of neutralizing antibody
Time Frame
28 days after the third dose of COVID-19 vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults 18 years old and older Over 6 months after primary immunization with COVID-19 vaccines Can understand and sign the consent Can provide effective personal identification Exclusion Criteria: Has a history of COVID-19 infection Less than 6 months after primary immunization with COVID-19 vaccines Already vaccinated with influenza vaccines of that year Vaccinated with pneumococcal vaccines within 5 years Has a history of severe hypersensitivity reaction to vaccines Has uncontrolled seizure or other severe neural system illnesses Has a fever, chronic disease, or acute disease during immunization Gestation period, lactation period, or planning to get pregnant within 3 months Administrated with other drugs under research within 30 days before vaccination Received attenuated vaccines within 14 days before vaccination Received subunit vaccines or inactivated vaccines within 7 days before vaccination Other conditions based on researcher's judgement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Wu, Bachelor
Phone
13381081732
Email
wj81732@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shuang Bai, Postgraduate
Phone
15210178395
Email
summer012388@hotmail.com
Facility Information:
Facility Name
Daxing District Center of Disease Control and Prevention
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Song
Phone
13810711075
Facility Name
Huairou District Center of Disease Control and Prevention
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiquan Wei
Phone
15201231087
Facility Name
Miyun District Center of Disease Control and Prevention
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siyao Li
Phone
1851596 9266

12. IPD Sharing Statement

Learn more about this trial

Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23

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