HUMMINGBIRD
Research type
Research Study
Full title
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
IRAS ID
1005711
Contact name
Kathleen Callahan
Contact email
Sponsor organisation
Novavax, Inc.
Eudract number
2022-000718-32
Clinicaltrials.gov Identifier
Research summary
We are testing a study vaccine called NVX-CoV2373 to see if it prevents COVID-19 in children. The vaccine works by making the body's immune system recognise and fight the SARS-CoV-2-virus that causes COVID-19. The vaccine has been authorised in various countries for adolescents and adults (12 years and older).
The participants, ca. 3600 children, are divided to three age groups: 6-11 years, 2-5 years and 6-23 months. A younger age group will start only after safety data from an older age group has been collected for 2 months. Depending on when a participant starts in the study, they will either have a 50% chance of receiving NVX-CoV2373 and a 50% chance of receiving placebo or a 67% chance of receiving NVX-CoV2373 and a 33% chance of receiving placebo. This is assigned randomly, like flipping a coin. A placebo looks like the study vaccine but includes no active medicine. Vaccinations take place at Days 0 and 21. About 6 months after the second dose we will know whether a participant received NVX-CoV2373 or placebo.
Participants who received NVX-CoV2373 will have a 50% chance of receiving NVX-CoV2373 and a 50% chance of receiving placebo for a booster (3rd) dose 6 months later. Those who received a placebo booster will receive a NVX-CoV2373 booster ca. 1 month later.
Participants who received placebo for their first 2 vaccinations, will then receive 2 doses of NVX-CoV2373, spaced about 21 days apart. About 6 months after the 2nd dose, they will receive a booster of NVX-CoV2373.
All participants will receive 3 NVX-CoV2373 vaccinations.
Participation lasts approximately 26 months, there are at least 8 visits to the study site and also contact by phone, email and text messages. The procedures include physical exams, height, weight, temperature and blood pressure, urine and blood tests, nasal swabs and filling in an eDiary.
This study is funded by Novavax, Inc, a pharmaceutical company that is based in the US.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
22/YH/0256
Date of REC Opinion
16 Feb 2023
REC opinion
Further Information Favourable Opinion