NCT05973006Phase 3Completed

Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines

Study sponsor: Novavax

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-04-01Actual

Enrollment · participants400Actual

Source updated2025-07-15Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

COVID-19

Treatments or interventions studied

NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccineBiologicalAlso known as NVX-CoV2601
Prototype/XBB.1.5 Bivalent Vaccine (5 µg)BiologicalAlso known as Omicron XBB.1.5 (sub-variant)SARS-CoV-2 rS /Matrix-M Adjuvant

Primary outcomes · main study measures

Read the study measures

measure: Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination; description: Participants with solicited local and systemic adverse events (AEs) To assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) for 7 days following vaccination; timeFrame: Day 7; measure: Participants With Unsolicited AEs Through 28 Days After Vaccination; description: Participants with unsolicited AEs to assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) through 28 days after vaccination.; timeFrame: Day 28; measure: Participants With (MAAEs) Attributed to Study Vaccine, (AESIs) (PIMMCs), Myocarditis and/or Pericarditis, and Complications Specific to COVID-19), and Serious Adverse Events (SAEs); description: Participants with medically attended adverse events (MAAEs) attributed to study vaccine, adverse events of special interest (AESIs) (predefined list including potential immune-mediated medical conditions (PIMMCs), myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs) o assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601)through day 180 or end of study (EOS).; timeFrame: Day 180; measure: Immunogenicity Index- Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.; description: The neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain assessed at Day 28 following initial study vaccination.; timeFrame: Day 0 and Day 28; measure: Immunogenicity Index- The Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.; description: the neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain, assessed at Day 28; timeFrame: Day 28

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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