Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years (NCT05468736) | Clinical Trial Compass
CompletedPhase 2/3
Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years
United States, Colombia, Dominican Republic3,600 participantsStarted 2022-07-22
Plain-language summary
This is a Phase 2/3 randomized, observer-blinded, placebo-controlled, age de-escalation trial to evaluate the safety and immunogenicity of 2 primary doses of SARS-CoV-2 rS with Matrix-M™ adjuvant (NVX-CoV2373) given 21 days apart and NVX CoV2373 or a variant-based vaccine given as a booster dose or at crossover in pediatric participants (3 age cohorts; 6 to \< 12 years, 2 to \< 6 years, and 6 to \< 24 months of age). Each age cohort will be conducted in 2 parts starting with the oldest age cohort (6 to \< 12 years of age).
Who can participate
Age range
6 Months – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Pediatric participants 6 months to \< 12 years of age at randomization, determined to be healthy or medically stable by the investigator (based on review of health status, vital signs \[to include body temperature\], medical history, and targeted physical examination \[to include body weight\]). Vital signs must be within the normal range prior to the first vaccination, according to the child's age, sex, weight, and height/length.
. For children from 6 months to \< 12 months of age: born at full-term (≥ 37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg).
. Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give informed consent and assent, as required, prior to study enrollment and to comply with study procedures.
. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 3 months after the last vaccination OR agree to consistently use a highly effective contraception method from at least 28 days prior to enrollment and through 3 months after the last vaccination.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reactogenicity Incidence and Severity
Timeframe: Day 0 to Day 7
2
Incidence and Severity of Medically Attended Adverse Events (MAAEs)
Timeframe: Day 0 to Day 28
3
Incidence and Severity of Unsolicited Adverse Events (AEs)
Timeframe: Day 0 to Day 28
4
Incidence and Severity of MAAEs Attributed to Study Vaccine
Timeframe: Day 0 to Day 730
5
Incidence and Severity of Serious Adverse Events (SAEs)
Timeframe: Day 0 to Day 730
6
Incidence and Severity of Adverse Events of Special Interest (AESIs)
. Agree not to participate in another SARS-CoV-2 prevention trial for the duration of the study.
Exclusion criteria
. Any acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F \[≥ 38.0°C\]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
. Unstable acute or chronic illness. Criteria for unstable medical conditions include:
. Substantive changes in chronic prescribed medication (change in class or significant change in dose) in the past 2 months.
. Currently undergoing workup of undiagnosed illness that could lead to a diagnosis of a new condition.
. Participation in research involving an investigational product (drug/biologic/device) administered within 45 days prior to the first study vaccination.
. History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
. Prior administration of an investigational, authorized, or approved Coronavirus vaccine (ie, against either SARS-CoV, SARS-CoV-2, or MERS CoV) or expected receipt during the period of study follow-up.