COVID-19 Vaccines, Immunogenicity, Vaccine, Influenza Vaccines, Pneumococcal Vaccines, Safety
Conditions
Keywords
Safety;Immunogenecity;Combined Immunization
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.
Interventions
BIOLOGICALVaccine
Different arms were administrated different vaccines
Sponsors
Centers for Disease Control and Prevention, China
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rate of neutralizing antibody | 28 days after the third dose of COVID-19 vaccine |
Countries
China
Contacts
Primary ContactJiang Wu, Bachelor
Backup ContactShuang Bai, Postgraduate
Outcome results
None listed