A Phase 2/3 Age De-escalating Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Vaccine (SARS-CoV-2 rS) with Matrix-M™ Adjuvant in Children 6 months to < 12 years of age (Hummingbird)

Status: Open to Recruitment 

Population: Paediatric 

Disease group: COVID 

Funder: Novavax

Sponsor: Novavax

Principal Investigator: Dr Eva Galiza 

Study Aims

The study vaccine introduces your child’s body to non-infectious parts (antigens) of the SARS-CoV-2 virus so his or her immune system can recognise the virus and fight it if your child is ever exposed to the virus. These antigens are combined with a substance called an adjuvant (Matrix-M) which helps increase the immune response. Because this vaccine is not made using infectious virus, it cannot give your child COVID-19. 

The main purpose of this study is to learn how well the study vaccine works and how safe the study vaccine is compared with placebo. A placebo is an inactive material (in this case, salt water) that looks like the study vaccine but does not contain any active study vaccine. 

What does participating in the study involve?

Your child will be in this study for approximately 26 months, and he or she will need to come to the study site at least 8 times over this period. You will also be regularly contacted (e.g., via phone calls, text messages, emails, etc.) by the study site during the study. This study is divided into 4 or 5 time periods depending on whether your child receives NVXCoV2373 or placebo, respectively, for the first set of vaccinations: a screening period, an initial vaccination period, an open-label crossover vaccination period (for children who receive placebo during the initial vaccination period), a booster vaccination period, and a follow-up period. During each study period, your child will have 1 or more visits with the study doctor at the study site. There will also be regular remote contacts where you will be contacted via phone, emails, text messages, etc. by the study site for safety follow-up. The screening visit will last about 2 hours, but all other visits will last about 1 to 1.5 (one and a half) hours. 

To find out more information about the study, contact hummingbird@sgul.ac.uk