Phase 3
N=400
Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT05973006 ↗Enrolled (actual)
400
Serious AEs
2.0%
Results posted
Jul 2025
Primary outcome: Primary: Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination — 153; 166; 136; 140 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine (Biological); Prototype/XBB.1.5 Bivalent Vaccine (5 µg) (Biological)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Novavax
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination |
153; 166; 136; 140; 116; 120 | — |
| PRIMARY Participants With Unsolicited AEs Through 28 Days After Vaccination |
25; 25; 15; 13; 4; 2 | — |
| PRIMARY Participants With (MAAEs) Attributed to Study Vaccine, (AESIs) (PIMMCs), Myocarditis and/or Pericarditis, and Complications Specific to COVID-19), and Serious Adverse Events (SAEs) |
25; 25; 16; 12; 4; 1 | — |
| PRIMARY Immunogenicity Index- Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. |
208.40; 184.81; 2533.08; 1544.61 | — |
| PRIMARY Immunogenicity Index- The Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain. |
12.2; 8.4 | — |
| SECONDARY Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. |
204.98; 183.37; 2533.08; 1544.61; 1816.50; 1171.90 | — |
| SECONDARY Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain. |
12.2; 8.4; 8.6; 6.2; 6.0; 4.7 | — |
| SECONDARY IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein. |
38825.1; 32881.9; 150232.9; 113031.9; 110091.1; 87102.4 | — |
| SECONDARY NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain . |
1321.00; 1197.59; 3510.84; 2803.80; 3381.08; 2924.82 | — |
| SECONDARY Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain . |
71388.4; 61296.9; 181736.6; 157077.8; 142032.4; 130155.1 | — |
Summary
This study is a large-scale investigation (Phase 3) into a new booster shot designed specifically for teenagers. The booster targets a particular variant of COVID-19, Omicron XBB.1.5. The main focus is on safety: researchers want to see if this new booster is safe for teenagers who have already received two doses of the Pfizer or Moderna mRNA COVID-19 vaccines. To ensure a fair comparison, the study will use a double-blind approach. This means two groups of teenagers will receive booster shots, but neither the teenagers nor the researchers giving the shots will know beforehand which version of the booster each person gets. The study will also assess how well the body fights the virus after the booster shot.
Eligibility Criteria
Inclusion Criteria
- Adolescents ≥ 12 to 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination.
An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical or intranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted.
- Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated.
- Active cancer (malignancy) on therapy within 3 years prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
- Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
- Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
- Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
- Study team member or immediate family member of any study team member (inclusive of Sponsor, clinical research organization [CRO], and study site personnel involved in the conduct or planning of the study).
- Participants with a history of myocarditis or pericarditis.
- Respiratory symptoms in the past 3 days (ie, cough, sore throat, difficulty breathing).
- Temperature of > 38°C within 24 hours of planned study vaccination (site measured or participant measured).
- Blood pressure of ≥ 160/100 mmHg.
Data sourced from ClinicalTrials.gov (NCT05973006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.