Open-label, Multi-centre, Non-Inferiority Study of Safety and Immunogenicity of BIMERVAX for the Prevention of COVID-19 in Adolescents From 12 Years to Less Than 18 Years of Age.

Last updated: February 23, 2024
Sponsor: Hipra Scientific, S.L.U
Overall Status: Active - Recruiting

Phase

2

Condition

Covid-19

Treatment

BIMERVAX

Clinical Study ID

NCT06234956
HIPRA-HH-3
  • Ages 12-17
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 informedconsent and can comply with all study visits and procedures. A written assent will berequired for all participants in the study. Note: Participants are expected to beavailable for the duration of the study and whose parent(s)/legal guardian can becontacted by telephone during study participation.
  • Participant must have received two previous doses of Comirnaty, last dose being atleast 6 months before screening.
  • Participant has a body mass index at or above the third percentile according to localChild 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 theinvestigator's judgment, are eligible for inclusion in the study. Note: Healthyparticipants are determined by medical history, physical examination, and clinicaljudgment of the investigator. Healthy participants with pre-existing stable diseases,are defined as diseases not requiring significant change in the therapy orhospitalisation for worsening disease during the 6 weeks before enrolment.
  • Has a negative Rapid Antigen Test (RAT) at Day 0 before BIMERVAX® vaccineadministration.
  • Participants biologically able to have children may be enrolled in the study if theparticipant fulfils all the following criteria:
  • Has a negative urine pregnancy test at Screening (Day 0), only for those participantswho are biologically able to become pregnant.
  • Has practiced adequate contraception or has abstained from all activities that couldresult in pregnancy for at least 28 days prior to the booster dose, only for thoseparticipants who are biologically able to become pregnant.
  • Has agreed to continue adequate contraception or abstinence through 3 months followingthe booster dose.
  1. Participants with female reproductive system:
  2. Hormonal contraception (progestogen only or combined: oral, injectable ortransdermal (patch)
  3. Intrauterine device.
  4. Vasectomized partner (the vasectomized partner should be the sole partnerfor that participant).
  5. Condom.
  6. Participants with male reproductive system:
  7. Vasectomized participants.
  8. 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 thecellular immunology assays.

Exclusion

Exclusion Criteria:

  • Acute illness with fever ≥ 38.0°C at Screening or within 24 hours prior tovaccination. Participant can be rescheduled for Screening when they have completed 24hours without fever. Afebrile participants with minor illnesses can be enrolled at thediscretion of the investigator.
  • Received medications intended to prevent or treat COVID-19 before Screening, exceptfor Comirnaty vaccines.
  • Previous or current diagnosis of MIS-C.
  • Other medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behaviour or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study. Note: This includes both conditions that may increase the risk associated with studyintervention administration or a condition that may interfere with the interpretation ofstudy results.
  • History of severe adverse reaction associated with a vaccine and/or severe allergicreaction (e.g. anaphylaxis) to any component of the study intervention(s).
  • Immunocompromised individuals defined as those with primary and secondary immunedeficiencies and those receiving chemotherapy or immunosuppressant drugs other thansteroids 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 90days prior to vaccination or during the study.
  • Bleeding diathesis or condition associated with prolonged bleeding that would, in theopinion of the investigator, contraindicate intramuscular injection.
  • Female who is pregnant or breastfeeding.
  • Receipt of blood/plasma products, immunoglobulin, monoclonal antibodies, or receipt ofany passive antibody therapy, within 90 days prior to vaccination or during the study.
  • Participation in other studies involving study intervention within 28 days prior toscreening and/or during study participation.
  • Received any non-study vaccine (including seasonal Influenza vaccine) within 14 daysbefore or after screening. For live or attenuated vaccines, 4 weeks before or afterscreening.
  • 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-19will not be eligible for the immunogenicity group.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: BIMERVAX
Phase: 2
Study Start date:
June 08, 2023
Estimated Completion Date:
December 30, 2024

Connect with a study center

  • CAP Centelles

    Centelles, Barcelona 08540
    Spain

    Active - Recruiting

  • CAP Peralada

    Peralada, Girona 17491
    Spain

    Active - Recruiting

  • Hospial HM Montepríncipe

    Boadilla Del Monte, Madrid 28660
    Spain

    Active - Recruiting

  • Hospital HM Puerta del Sur

    Móstoles, Madrid 28938
    Spain

    Active - Recruiting

  • Hospital Vall Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Josep Trueta

    Girona, 17007
    Spain

    Active - Recruiting

  • Hospital La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

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