Clinical trial NCT05298800: Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23
Official title: Clinical Observation of Combined Immunization of COVID-19 Inactivated Vaccine With Quadrivalent Influenza Vaccine(QIV) and 23-valent Pneumococcal Polysaccharide Vaccine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Safety
Immunogenicity, Vaccine
COVID-19 Vaccines
Influenza Vaccines
Pneumococcal Vaccines
Keywords: Safety;Immunogenecity;Combined Immunization
Lead sponsor: Centers for Disease Control and Prevention, China
Sponsor class: OTHER_GOV
First posted: 2022-03-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Seroconversion rate of neutralizing antibody
timeFrame: 28 days after the third dose of COVID-19 vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Daxing District Center of Disease Control and Prevention
city: Beijing
country: China
facility: Huairou District Center of Disease Control and Prevention
city: Beijing
country: China
facility: Miyun District Center of Disease Control and Prevention
Study officials:
References: