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

March 24, 2022 updated by: Wu Jiang, Centers for Disease Control and Prevention, China

Clinical Observation of Combined Immunization of COVID-19 Inactivated Vaccine With Quadrivalent Influenza Vaccine(QIV) and 23-valent Pneumococcal Polysaccharide Vaccine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

3000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Daxing District Center of Disease Control and Prevention
        • Contact:
          • Xin Song
          • Phone Number: 13810711075
      • Beijing, China
        • Recruiting
        • Huairou District Center of Disease Control and Prevention
        • Contact:
          • Zhiquan Wei
          • Phone Number: 15201231087
      • Beijing, China
        • Recruiting
        • Miyun District Center of Disease Control and Prevention
        • Contact:
          • Siyao Li
          • Phone Number: 1851596 9266

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COVID-19 and QIV
Biological: Vaccine
Different arms were administrated different vaccines
Experimental: COVID-19 and PPV23
Biological: Vaccine
Different arms were administrated different vaccines
Experimental: COVID-19
Biological: Vaccine
Different arms were administrated different vaccines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seroconversion rate of neutralizing antibody
Time Frame: 28 days after the third dose of COVID-19 vaccine
28 days after the third dose of COVID-19 vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJCDCWJ202202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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