This is a Phase IIb, open-label, uncontrolled, multi-centre, non-inferiority clinical trial, to assess the safety and immunogenicity of BIMERVAX® as a heterologous booster dose in adolescents. In this study a total of 300 adolescents from 12 to less than 18 years will be enrolled and followed for 12 months.
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Changes in immunogenicity against Omicron BA.1
Timeframe: 14 days
Changes in immunogenicity against Omicron BA.1
Timeframe: 14 days
Incidence of solicited local and systemic reactions (Safety and tolerability of PHH-1V)
Timeframe: 7 days
Incidence of unsolicited local and systemic adverse events (Safety and tolerability of PHH-1V)
Timeframe: 28 days
Incidence of related adverse events and serious adverse events (Safety and tolerability of PHH-1V)
Timeframe: 1 year
Incidence of adverse events of special interest (Safety and tolerability of PHH-1V)
Timeframe: 1 year
Incidence of related medically attended adverse events (Safety and tolerability of PHH-1V)
Timeframe: 1 year
Incidence of Grade 2, Grade 3 and Grade 4 changes in safety laboratory parameters (Safety and tolerability of PHH-1V)
Timeframe: 14 days