Immunogenicity and Safety of the SpikoGen COVID-19 Vaccine in Children Aged 5 to <12 Years and 12 to <18 Years Compared With Adults Aged 18 to 40 Years
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cinnagen
With
Vaxine Pty Ltd
Age
5–40
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Male or female between 5 and 40 years of age inclusive
Willing and able to comply with all study requirements, including scheduled visits, interventions, and laboratory tests
Healthy adults or adults in a stable medical condition, defined as not being hospitalized within 3 months prior to the screening visit
Females must not be pregnant or breastfeeding
Children with a body mass index equal to or greater than the 3rd percentile for age and sex as per the World Health Organization child growth standards
You may not be if
Subjects with signs of active SARS-CoV-2 infection at the screening visit.
Subjects with epilepsy or a history of febrile seizures
Subjects who receive immunosuppressive or cytotoxic medications.
Subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the study vaccine, any components of the study interventions, or any pharmaceutical products.
Subjects who have received any other investigational products within 30 days prior to the screening visit or intend to participate in any other clinical studies during the period of this study.
Subjects who have been vaccinated with any vaccine or vaccine candidate against SARS-CoV-2.
Subjects who have received any vaccines within 28 days prior to the screening visit or intend to receive any vaccines up to day 14 of the study.
Subjects who have any known bleeding disorders or, in the investigator's opinion, have any contraindications for an intramuscular injection.
Subjects who have received any blood, plasma, or immunoglobulin products from 90 days prior to the screening visit or intend to receive during the study period.
Subjects with any condition that may increase the risk of participating in the study or may interfere with the evaluation of the primary endpoints of the study in the investigator's opinion.
Subjects who have donated ≥450 mL of blood or blood products within 28 days prior to the screening visit.
Clareo Health | Immunogenicity and Safety of the SpikoGen COVID-19 Vaccine in Children Aged 5 to <12 Years and 12 to <18 Years Compared With Adults Aged 18 to 40 Years
