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

NCT05298800 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2022-03-28

No results posted yet for this study

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.

Conditions

  • Safety
  • Immunogenicity, Vaccine
  • COVID-19 Vaccines
  • Influenza Vaccines
  • Pneumococcal Vaccines

Interventions

BIOLOGICAL

Vaccine

Different arms were administrated different vaccines

Sponsors & Collaborators

  • Centers for Disease Control and Prevention, China

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05298800 on ClinicalTrials.gov