TCTR20220120002
Not yet recruiting
Phase 3
Phase 3 study, to evaluate the safety and immunogenicity of HXP-GPOVac vaccine in comparison to AstraZeneca's AZD1222 COVID-19 vaccine
ConditionsHealthy male and female subjects
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Healthy male and female subjects
- Sponsor
- The Government Pharmaceutical Organization
- Enrollment
- 4000
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be eligible to participate in this study, an individual must meet all of the following criteria
- •1\.Willingness to provide a signed and dated informed consent form.
- •2\.Stated willingness to comply with all study procedures and availability for the duration of the study.
- •3\.Be a Thai male or female 18 years of age or older.
- •4\.For females\- Be of non\-childbearing potential or willing to use appropriate contraceptive measures for 30 days prior to vaccination through two months after completion of the vaccine series. Non\-childbearing potential means being surgically sterilized or at least one year post\-menopausal. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions (i.e. intrauterine or implantable contraceptive device, oral contraceptives\-diaphragm or condom in combination with contraceptive jelly, cream or foam).
- •5\.For healthy participants with pre\-existing medical conditions\-Be in stable condition that has not worsened over the three months before enrollment to require hospitalization or significant changes in therapy.
Exclusion Criteria
- •An individual who meets any of the following criteria will be excluded from participation in this study
- •1\. Self\-reported history of COVID\-19 disease or history of laboratory\-confirmed COVID\-19 (RT\-PCR positive to SARS\-CoV\-2\).
- •2\.Prior receipt of a COVID\-19 vaccine.
- •3\. Prior or planned administration of a non\-study vaccine within 30 days before the first dose of study vaccine or 30 days after the second vaccination, respectively.
- •4\. History of allergic reactions or anaphylaxis to any previous immunizations.
- •5\. History of allergies to eggs, chicken, or any components of the study vaccine.
- •6\. Fever (More than 38\.0 celsius) within the past 24 hours.
- •7\. Administration of immunoglobulins and,or any blood products within the three months preceding the planned administration of the study vaccine.
- •8\. History of bleeding disorder (example factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular (IM) injections or venipuncture.
Outcomes
Primary Outcomes
Not specified
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