None listed
Conditions
Interventions
Intervention1: GEMCOVAC-19 (COVID-19 vaccine): In 12 to less than 18 years, GEMCOVAC-19 will be administered as a 2 dose schedule on Day 1 and 29 at 10 micrograms intramuscularly.
In 5-11 years , GEM
Sponsors
Gennova Biopharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Phase II: 1.Male and female subjects’ 5- 2.Healthy as judged by medical history, physical and other examination or screening laboratory assessments or other investigations and in the clinical opinion of the Investigator. 3.Age group 12 - Subject’s parent should be capable and willing to give voluntary written informed consent and subject should be capable and willing to give voluntary assent prior to inclusion in the study. 4.Age group: 5 - 11 years: Subject’s parent should be capable and willing to give voluntary written informed consent prior to inclusion in the study 5.Negative / Non-reactive RT-PCR screening of nasopharyngeal swabs/suitable sample for SARS CoV-2 6.Subject/ subject’s parent is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. Inclusion Criteria for Phase III: 1.Male and female subjects’ 5 - 2.Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator. 3.Age group 12 - Subject’s parent should be capable and willing to give voluntary written informed consent and subject’s should be capable and willing to give voluntary assent form prior to inclusion in the study. 4.Age group: 5 - 11 years: Subject’s parent should be capable and willing to give voluntary written informed consent prior to inclusion in the study. 5.Subject’s parent/subjects is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Phase II: 1.Subject with a recent history of COVID-19 infection within 3 months of Screening. 2.Subjects received an investigational vaccine or vaccine which have been granted an emergency use to prevent COVID-19 infection. 3.Protocol defined laboratory assessments outside the range/limit defined in Appendix 2. Any other laboratory value if = Grade 2 as per DAIDs* criteria * Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1, July 2017, of the US National Institutes of Health 4.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days 5.Any significant illness or any other current or pre-existing health condition (e.g., any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. 6.History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine. 7.Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature = 38°C or = 100.4 °F or its equivalent for axillary and tympanic) within 48 hours prior to vaccination. 8.History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease. 9.Subjects willing to get married and planning for pregnancy within 4 months of study participation (only applicable for participants of 15 - (smaller than)18 years age). 10.Prior major surgery or any radiation therapy within 4 weeks of Screening visit. 11.Positive serologic test for HIV 1 and 2, HBsAg and HCV. 12.Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day). 13.Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination. 14.Eczema or other significant skin lesion or infection at the site of vaccination. 15.Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit. 16.Bleeding diathesis or condition associated with prolonged bleeding. 17.Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate. 18.Any other condition which in the opinion of the Investigator may affect subject’s safety or participation. Exclusion Criteria for Phase III: 1.Subject with a recent history of COVID-19 infection within 3 months from Screening 2.Subjects received an investigational vaccine or vaccine which have been granted an emergency use to prevent COVID-19 infection. 3.Any significant illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. 4.Histor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (Phase II ) Occurrence and severity of local and systemic reactogenicity adverse events, unsolicited events and serious adverse events (SAE) Immunogenicity (Phase II and III) Age group: 12 - Less than 18 years Geometric mean titer (GMT) of SARS-CoV-2 specific serum neutralizing antibody levels using live virus [Plaque Reduction Neutralization Test (PRNT)] Immunogenicity (Phase II and III) Age group: 5 - 11 years GMT as measured by IgG-ELISA against SARS-CoV-2 Spike proteinTimepoint: Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. At Day 57. At Day 43. | — |
Secondary
| Measure | Time frame |
|---|---|
| Age Group 12 to less than 18 (Phase II and III) GMT of anti-spike IgG GMFR in anti-spike IgG Proportion seroconverted Neutralization using cPASS Assay Cellular Immune Response Phase III only Safety, Tolerability and Immunogenicity Timepoint: At Day 57 (28 days post Dose 2), Day 119 and Day 209 At Baseline and Day 57 At Day 57 At Day 57, Day 119 and Day 209 visit At Day 119 and Day 209 visit Entire duration of study;Age Group 5 to 11 year old (Phase II and III) GMFR in anti-spike IgG Proportion seroconverted Neutralization using PRNT and Cpass Phase III only Safety, Tolerability and Immunogenicity Timepoint: Day 43 Day 43 Day 43 Entire duration of study | — |
Countries
India
Contacts
Public ContactDr Amit Saraf
Gennova Biopharmaceuticals Limited
Outcome results
None listed