CompletedPhase 3

Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age

United States945 participantsStarted 2020-08-25

Plain-language summary

The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.

Who can participate

Age range16 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and 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. * Previous vaccination with 1 dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable. * Written or /witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. * Written informed assent obtained from the participant (if applicable) along with informed consent from the participant's parent(s)/LAR(s) prior to performing any study specific procedure. * A male or female between, and including, 16 and 18 years of age at the time of the first vaccination. * Healthy participants as established by medical history and clinical examination before entering the study. * Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. * Female participants of childbearing potential may be enrolled in the study if the participant: * has practiced adequate contraception for 30 days prior to vaccination, and * has a…

What they're measuring

Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ

Timeframe: During 7 days after the rMenB+OMV NZ vaccination at Day 1

Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ

Timeframe: During 7 days after the rMenB+OMV NZ vaccination at Day 61

Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ

Timeframe: During 7 days after the rMenB+OMV NZ vaccination at Day 91

Number of Participants With Solicited Local AEs After the Vaccination With MenACWY

Timeframe: During 7 days after the MenACWY vaccination at Day 1

Number of Participants With Solicited Local AEs After the Vaccination With MenACWY

Timeframe: During 7 days after the MenACWY vaccination at Day 61

Number of Participants With Solicited Local AEs After the Vaccination With MenACWY

Timeframe: During 7 days after the MenACWY vaccination at Day 91

Number of Participants With Solicited Local AEs After the Vaccination With Placebo

Trial details

NCT IDNCT04318548

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-21

Results submitted2024-12-24

View on ClinicalTrials.gov More Infections, Meningococcal trials