CompletedPhase 2

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

Dominican Republic, Finland, Germany726 participantsStarted 2021-11-29

Plain-language 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 (MenACWY-7b) 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.

Who can participate

Age range

55 Days – 89 Days

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' 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 an…

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 Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1

Timeframe: From Day 1 to Day 7

Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1

Timeframe: From Day 1 to Day 7

Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61

Timeframe: From Day 61 to Day 67

Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61

Timeframe: From Day 61 to Day 67

Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301

Timeframe: From Day 301 to Day 307

Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301

Timeframe: From Day 301 to Day 307

Trial details

NCT IDNCT05082285

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-31

Results submitted2026-03-31

View on ClinicalTrials.gov More Infections, Meningococcal trials

Plain-language summary

Who can participate

Age range

55 Days – 89 Days

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.

What they're measuring

Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1

Timeframe: From Day 1 to Day 7

Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1

Timeframe: From Day 1 to Day 7

Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61

Timeframe: From Day 61 to Day 67

Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61

Timeframe: From Day 61 to Day 67

Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301

Timeframe: From Day 301 to Day 307

Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301

Timeframe: From Day 301 to Day 307