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 States, Italy945 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 range

16 Years – 18 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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