Official Title
Open-label, Multi-centre, Non-Inferiority Study of Safety and Immunogenicity of BIMERVAX as Heterologous Booster for the Prevention of Coronavirus Disease 2019 (COVID-19) in Adolescents From 12 Years to Less Than 18 Years of Age.
Brief Summary

This is a Phase IIb, open-label, uncontrolled, multi-centre, non-inferiority clinicaltrial, to assess the safety and immunogenicity of BIMERVAX® as a heterologous boosterdose in adolescents.In this study a total of 300 adolescents from 12 to less than 18 years will be enrolledand followed for 12 months.

Detailed Description

Not Provided

Recruiting
SARS CoV 2 Infection

Biological: BIMERVAX

BIMERVAX

Eligibility Criteria

Inclusion Criteria:

- Adolescents aged from 12 to less than 18 years at Screening.

- Participant's parent(s)/legal guardian(s) willing and able to sign the informed
consent and can comply with all study visits and procedures. A written assent will
be required for all participants in the study. Note: Participants are expected to be
available for the duration of the study and whose parent(s)/legal guardian can be
contacted by telephone during study participation.

- Participant must have received two previous doses of Comirnaty, last dose being at
least 6 months before screening.

- Participant has a body mass index at or above the third percentile according to
local Child Growth Standards at Screening Visit.

- Healthy participants and participants with pre-existing, chronic and stable diseases
(non-immunocompromised), if these are stable and well-controlled according to the
investigator's judgment, are eligible for inclusion in the study. Note: Healthy
participants are determined by medical history, physical examination, and clinical
judgment of the investigator. Healthy participants with pre-existing stable
diseases, are defined as diseases not requiring significant change in the therapy or
hospitalisation for worsening disease during the 6 weeks before enrolment.

- Has a negative Rapid Antigen Test (RAT) at Day 0 before BIMERVAX® vaccine
administration.

- Participants biologically able to have children may be enrolled in the study if the
participant fulfils all the following criteria:

- Has a negative urine pregnancy test at Screening (Day 0), only for those
participants who are biologically able to become pregnant.

- Has practiced adequate contraception or has abstained from all activities that could
result in pregnancy for at least 28 days prior to the booster dose, only for those
participants who are biologically able to become pregnant.

- Has agreed to continue adequate contraception or abstinence through 3 months
following the booster dose.

1. Participants with female reproductive system:

1. Hormonal contraception (progestogen only or combined: oral, injectable or
transdermal (patch)

2. Intrauterine device.

3. Vasectomized partner (the vasectomized partner should be the sole partner
for that participant).

4. Condom.

2. Participants with male reproductive system:

1. Vasectomized participants.

2. Agree to use a condom in partners biologically able to become pregnant.

- Participant must have a body weight >50 kg at Screening visit to be eligible for the
cellular immunology assays.

Exclusion Criteria:

- Acute illness with fever ≥ 38.0°C at Screening or within 24 hours prior to
vaccination. Participant can be rescheduled for Screening when they have completed
24 hours without fever. Afebrile participants with minor illnesses can be enrolled
at the discretion of the investigator.

- Received medications intended to prevent or treat COVID-19 before Screening, except
for Comirnaty vaccines.

- Previous or current diagnosis of MIS-C.

- Other medical or psychiatric condition including recent (within the past year) or
active suicidal ideation/behaviour or laboratory abnormality that may increase the
risk of study participation or, in the investigator's judgment, make the participant
inappropriate for the study.

Note: This includes both conditions that may increase the risk associated with study
intervention administration or a condition that may interfere with the interpretation of
study results.

- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (e.g. anaphylaxis) to any component of the study intervention(s).

- Immunocompromised individuals defined as those with primary and secondary immune
deficiencies and those receiving chemotherapy or immunosuppressant drugs other than
steroids and glucocorticoids (maximum 1 mg/kg/day of prednisone or total dose of
20mg/day by any administration route for a maximum of 30 consecutive days), within
90 days prior to vaccination or during the study.

- Bleeding diathesis or condition associated with prolonged bleeding that would, in
the opinion of the investigator, contraindicate intramuscular injection.

- Female who is pregnant or breastfeeding.

- Receipt of blood/plasma products, immunoglobulin, monoclonal antibodies, or receipt
of any passive antibody therapy, within 90 days prior to vaccination or during the
study.

- Participation in other studies involving study intervention within 28 days prior to
screening and/or during study participation.

- Received any non-study vaccine (including seasonal Influenza vaccine) within 14 days
before or after screening. For live or attenuated vaccines, 4 weeks before or after
screening.

- History of illegal substance use or alcohol abuse within the past 2 years.

- History of a diagnosis or other conditions that, in the judgment of the
investigator, may affect study endpoint assessment or compromise participant safety.

- Individuals who are family members of the Investigators.

- Individuals with documented medical history of microbiologically confirmed COVID-19
will not be eligible for the immunogenicity group.

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: 17 Years
Countries
Spain
Locations

CAP Centelles
Centelles, Barcelona, Spain

CAP Peralada
Peralada, Girona, Spain

Hospial HM Montepríncipe
Boadilla Del Monte, Madrid, Spain

Hospital HM Puerta del Sur
Móstoles, Madrid, Spain

Hospital Vall Hebron
Barcelona, Spain

Hospital Josep Trueta
Girona, Spain

Hospital La Paz
Madrid, Spain

Contacts

Teresa Prat
972430660
teresa.prat@hipra.com

Mar Armengol, PhD
972430660
mar.armengol@hipra.com

Not Provided

Hipra Scientific, S.L.U
NCT Number
MeSH Terms
COVID-19