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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
242
BIMERVAX
Hospital Vall Hebron
Barcelona, Barcelona, Spain
CAP Centelles
Centelles, Barcelona, Spain
Hospital Josep Trueta
Girona, Girona, Spain
CAP Peralada
Peralada, Girona, Spain
Changes in immunogenicity against Omicron BA.1
Neutralisation titre against Omicron BA.1 measured as inhibitory concentration 50 (IC50) by PBNA and reported as log10 concentration for each individual sample at Baseline and Day 14.
Time frame: 14 days
Changes in immunogenicity against Omicron BA.1
Geometric Mean Titre (GMT) for group comparison with HIPRA-HH-2 at Baseline and Day 14.
Time frame: 14 days
Incidence of solicited local and systemic reactions (Safety and tolerability of PHH-1V)
Solicited local and systemic reactions through Day 7 after vaccination.
Time frame: 7 days
Incidence of unsolicited local and systemic adverse events (Safety and tolerability of PHH-1V)
Unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination.
Time frame: 28 days
Incidence of related adverse events and serious adverse events (Safety and tolerability of PHH-1V)
Related adverse events (AEs) and all serious adverse events (SAEs) through the end of the study.
Time frame: 1 year
Incidence of adverse events of special interest (Safety and tolerability of PHH-1V)
Adverse event of special interest (AESI) through the end of the study.
Time frame: 1 year
Incidence of related medically attended adverse events (Safety and tolerability of PHH-1V)
Related medically attended adverse events (MAAE) through the end of the study.
Time frame: 1 year
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Hospital HM Montepríncipe
Boadilla del Monte, Madrid, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital HM Puerta del Sur
Móstoles, Madrid, Spain
Incidence of Grade 2, Grade 3 and Grade 4 changes in safety laboratory parameters (Safety and tolerability of PHH-1V)
Grade 2, Grade 3 and Grade 4 changes from Baseline in safety laboratory parameters through Day 14 after vaccination.
Time frame: 14 days
Changes in immunogenicity against VOCs
Neutralisation titre against VOCs (at least Beta and Delta) measured as IC50 by PBNA and reported as log10 concentration for each individual sample at Baseline and Days 14, 84, 168 and 336.
Time frame: Days 14, 84, 168 and 336
Changes in immunogenicity against VOCs
GMT at Baseline and Days 14, 84, 168 and 336.
Time frame: Days 14, 84, 168 and 336
Changes in immunogenicity against Omicron BA.1 and VOCs
GMFR in neutralising antibodies titres against Omicron BA.1 and VOCs (at least Beta and Delta) at Baseline and Day 14.
Time frame: Day 14