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.
Age range
12 Years – 17 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.
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.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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