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

Safety Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05298800
• Other study ID #: BJCDCWJ202202
• Status: Recruiting
• Phase: Phase 4
• Start date: October 8, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Centers for Disease Control and Prevention, China
• Contact: Jiang Wu, Bachelor
• Phone: 13381081732
• Email: wj81732[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• Vaccine
Different arms were administrated different vaccines

Locations

Country	Name	City	State
China	Daxing District Center of Disease Control and Prevention	Beijing
China	Huairou District Center of Disease Control and Prevention	Beijing
China	Miyun District Center of Disease Control and Prevention	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate of neutralizing antibody		28 days after the third dose of COVID-19 vaccine