NCT05298800

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Centers for Disease Control and Prevention, China · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	Vaccine	Different arms were administrated different vaccines

Timeline

• Start date: 2021-10-08
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2022-03-28
• Last updated: 2022-03-28

Locations

3 sites across 1 country: China