C3671017 A PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS VACCINE IN CHILDREN AT HIGH RISK OF RSV DISEASE

Conditions

Prevention of lower respiratory tract disease caused by respiratory syncytial virus

Brief summary

Cohort 1 (a and b) - Safety: • Prespecified local reactions (pain at the injection site, redness, and swelling) • Prespecified systemic events (fever, new or worsened vomiting, new or worsened diarrhea, new or worsened headache, new or worsened fatigue/tiredness, new or worsened muscle pain, and new or worsened joint pain) • Adverse events (AEs) • Serious adverse events (SAEs) • Newly diagnosed chronic medical conditions (NDCMCs), Cohort 1 (a and b) - Immunogenicity: Respiratory syncytial virus subgroup A (RSV A) and respiratory syncytial virus subgroup B (RSV B) neutralizing titers (NTs), Cohort 2 (a and b) - Safety: • Prespecified local reactions (pain at the injection site, redness, and swelling) • Prespecified systemic events (fever, new or worsened vomiting, new or worsened diarrhea, new or worsened headache, new or worsened fatigue/tiredness, new or worsened muscle pain, and new or worsened joint pain) • AEs • SAEs • NDCMCs, Cohort 2 (a and b) - Immunogenicity: RSV A and RSV B NTs

Detailed description

Cohort 1 (a and b) - Immunogenicity: RSV A and RSV B NTs

Related papers

No related papers found yet.

Interventions

DRUGAbrysvo Placebo

DRUGAbrysvo powder and solvent for solution for injection Respiratory syncytial virus vaccine (bivalent

DRUGrecombinant)

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Cohort 1 (a and b) - Safety: • Prespecified local reactions (pain at the injection site, redness, and swelling) • Prespecified systemic events (fever, new or worsened vomiting, new or worsened diarrhea, new or worsened headache, new or worsened fatigue/tiredness, new or worsened muscle pain, and new or worsened joint pain) • Adverse events (AEs) • Serious adverse events (SAEs) • Newly diagnosed chronic medical conditions (NDCMCs), Cohort 1 (a and b) - Immunogenicity: Respiratory syncytial virus subgroup A (RSV A) and respiratory syncytial virus subgroup B (RSV B) neutralizing titers (NTs), Cohort 2 (a and b) - Safety: • Prespecified local reactions (pain at the injection site, redness, and swelling) • Prespecified systemic events (fever, new or worsened vomiting, new or worsened diarrhea, new or worsened headache, new or worsened fatigue/tiredness, new or worsened muscle pain, and new or worsened joint pain) • AEs • SAEs • NDCMCs, Cohort 2 (a and b) - Immunogenicity: RSV A and RSV B NT	—

Measure

Time frame

Cohort 1 (a and b) - Safety: • Prespecified local reactions (pain at the injection site, redness, and swelling) • Prespecified systemic events (fever, new or worsened vomiting, new or worsened diarrhea, new or worsened headache, new or worsened fatigue/tiredness, new or worsened muscle pain, and new or worsened joint pain) • Adverse events (AEs) • Serious adverse events (SAEs) • Newly diagnosed chronic medical conditions (NDCMCs), Cohort 1 (a and b) - Immunogenicity: Respiratory syncytial virus subgroup A (RSV A) and respiratory syncytial virus subgroup B (RSV B) neutralizing titers (NTs), Cohort 2 (a and b) - Safety: • Prespecified local reactions (pain at the injection site, redness, and swelling) • Prespecified systemic events (fever, new or worsened vomiting, new or worsened diarrhea, new or worsened headache, new or worsened fatigue/tiredness, new or worsened muscle pain, and new or worsened joint pain) • AEs • SAEs • NDCMCs, Cohort 2 (a and b) - Immunogenicity: RSV A and RSV B NT

—

Secondary

Measure	Time frame
Cohort 1 (a and b) - Immunogenicity: RSV A and RSV B NTs	—

Outcome results

None listed