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

NCT05298800 PHASE4 UNKNOWN

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.

Details

Lead sponsor	Centers for Disease Control and Prevention, China
Phase	PHASE4
Status	UNKNOWN
Enrolment	3000
Start date	Fri Oct 08 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sun Dec 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

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

Interventions

• Vaccine

Countries

China