None listed
Conditions
Interventions
Intervention1: Immunace forte & Ultra D3 tablets: Immunace forte one tablet orally after main meal & Ultra D3 tablets one tablet orally after main meal for for 15 to 19 weeks
Control Intervention1: Ni
Sponsors
Meyer Organics Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Provides written informed consent prior to initiation of any study procedures. 2.Be able to understand and agrees to comply with planned study procedures and be available for all study visits. 3.Agrees to the collection of venous blood per protocol. 4.Male or non-pregnant female, > 18 years of age at time of enrollment. 5.Body Mass Index (BMI) 18.0-35.0 kg/m2 at screening. 6.Women of childbearing potential must agree to use acceptable primary form of contraception 7.In good health and with stable prescription for comorbidities if any.
Exclusion criteria
Exclusion criteria: 1.Confirmed pregnancy test either at screening or just prior to each vaccine administration. 2.Female subject who is breastfeeding. 3.Has any medical disease or condition that, in the opinion of the participating site principal investigator (PI) or appropriate sub-investigator, precludes study participation. 4.Presence of self-reported or medically documented significant medical or psychiatric condition(s). 5.Currently enrolled in or plans to participate in another clinical trial with an investigational agent or receiving similar medication that of investigational product for prophylaxis of COVID-19. 6.Uncontrolled comorbidity. 7.Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness. 8.Received immunoglobulin and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study. 9.Has any significant hematological disorder of coagulation. 10.Has any chronic liver disease, including fatty liver. 11.Has a history of alcohol or drugs abuse. 12.History of documented infection of COVID-19.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.SARS-CoV-2 serum neutralizing antibody levels. 2.Percentage of subjects turning RT-PCR positive for Covid-19 after vaccinationTimepoint: Baseline within 1 week of first dose of vaccine, At second dose of vaccine ie Weeks 12-16 after First dose of vaccine and 3 weeks after second dose of vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Percentage of participants reporting systemic events (After dose 1 and 2) in age, comorbidity standardized manner and according to the systemic event categorization i.e. Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain. 2.Tolerability of intervention by study subjects 3.Safety of intervention evident by adverse eventsTimepoint: Baseline within 1 week of first dose of vaccine, At second dose of vaccine ie Weeks 12-16 after First dose of vaccine and 3 weeks after second dose of vaccine | — |
Countries
India
Contacts
Public ContactMs Tania Dcruz
Meyer Organics Pvt. Ltd.
Outcome results
None listed