A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    688
  • sponsor
    GlaxoSmithKline
Updated on 27 May 2022
Accepts healthy volunteers

Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY-2Gen) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.

Details
Condition Infections, Meningococcal
Treatment MenB vaccine, MenABCWY-2Gen low dose vaccine, MenABCWY-2Gen high dose vaccine, MenABCWY-1Gen vaccine, MenACWY-TT vaccine
Clinical Study IdentifierNCT05082285
SponsorGlaxoSmithKline
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol
Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure
Healthy participants as established by medical history and clinical examination before entering into the study
A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination
Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg

Exclusion Criteria

Medical conditions
Current or previous, confirmed or suspected disease caused by N. meningitidis
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection from birth
Progressive, unstable or uncontrolled clinical conditions
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
Any neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures
Congenital or peripartum disorders resulting in a chronic condition
Major congenital defects, as assessed by the investigator
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s)
Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study
Abnormal function or modification of the immune system resulting from
Autoimmune disorders or immunodeficiency syndromes
Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days starting from birth until Visit 5. This will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed
Administration of antineoplastic and immunomodulating agents or radiotherapy from birth
Administration of long-acting immune-modifying drugs at any time during the study period
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study
Prior/Concomitant therapy
Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccines from birth, or planned use during the study period
Previous vaccination with any meningococcal vaccine
Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting from birth until Visit 5. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed
Prior/Concurrent clinical study experience
Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device)
Other exclusions
Child in care
Study personnel as an immediate family or household member
For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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