Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Two Attenuated Vaccines

Launched by SHANGHAI MUNICIPAL CENTER FOR DISEASE CONTROL AND PREVENTION · Jul 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of an inactivated vaccine for COVID-19 (SARS-CoV-2) when given alongside other vaccines for chickenpox (varicella), measles, mumps, and rubella (MMR). Participants will be randomly placed into one of three groups to receive these vaccines at different times over a period of 28 days, with blood samples taken to monitor their immune response and any side effects before and after vaccination.

To be eligible for this trial, participants must be at least 4 years old and have a legal guardian who can provide consent. They should have a complete vaccination history, including having received one chickenpox vaccine and two measles-containing vaccines, with no previous COVID-19 vaccinations. It's important that participants are in good health, with no recent COVID-19 infections or serious allergies to vaccines. During the study, participants will receive their vaccines, complete diary cards to track any side effects, and attend follow-up visits, all while being closely monitored for their health and safety throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 4 years old
• • With legal guardian signing the informed consent
• • Able to participate in all planned visits and comply with all research procedures (such as completing diary cards of adverse events and participating visits)
• • With clear vaccination records including no SARS-CoV-2 vaccine history, with 1 varicella vaccine and 2 measles-containing vaccines history
• • the last attenuated vaccine was administered ≥28 days ago, and other vaccines administered ≥14 days ago
• • With an axillary temperature ≤37.5℃ at the time of vaccination
• Exclusion Criteria:
• First dose exclusion criteria:
• • With SARS-CoV-2 infection in the last 3 months (any of the following conditions shall be met: positive nucleic acid test; positive antigen test; suspected SARS-CoV-2 infection symptoms of subject or close contacts)
• • allergic to any substance of the vaccine or with a severe allergic reactions history of vaccines (such as acute allergic reactions, angioneurotic edema, breathing difficulties, etc.)
• • Suffering uncontrolled epilepsy or progressive nerve system diseases, or with a history of Gribali syndrome
• • With acute illness, severe or acute attack of chronic illness or fever
• • With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs (oral steroids)
• • Received non specific immunoglobulin within 3 months
• • Any situation that researchers thought that might influence the consequence of the clinical trial Second dose exclusion criteria：
• • Occurrence of any serious adverse event that may be related to the previous dose of study vaccine
• • Occurrence of systemic adverse reactions or allergic reactions with a severity level ≥ 3 recognized by researchers after vaccination
• • Any new situations that fit the first dose exclusion criteria
• • Any situation that researchers thought that might influence the consequence of the clinical trial