CompletedPhase 3

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

United States, Puerto Rico1,196 participantsStarted 2018-07-27

Plain-language summary

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccinesv(RIV).

Who can participate

Age range

6 Weeks – 12 Weeks

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: All subjects must satisfy all the following criteria at study entry: * Subjects' 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 (e.g. completion of the eDiary, return for follow-up visits). * Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure. * A male or female between, and including, 42 and 84 days of age (i.e., 6 through 12 weeks) at the time of the 1st vaccination. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born full-term (i.e. after a gestation period of ≥ 38 weeks). Exclusion Criteria: If any exclusion criterion applies, the subject must not be included in the study: • Child in care Each subject must not have: * Progressive, unstable or uncontrolled clinical conditions. * Hypersensitivity, including allergy to any component of vaccines, medicinal product or medical equipment whose use is foreseen in this study. * Hypersensitivity to latex. * Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. * Abnormal function of the immune system resulting from: * Clinical conditions. * Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth. * Administration of antineoplastic and immunomodulating agents or radioth…

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 at Day 1

Timeframe: Day 1 to Day 7

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

Timeframe: Day 1 to Day 7

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

Timeframe: Day 61 to Day 67

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

Timeframe: Day 61 to Day 67

Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121

Timeframe: Day 121 to Day 127

Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121

Timeframe: Day 121 to Day 127

Trial details

NCT IDNCT03621670

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-27

Results submitted2025-12-23

View on ClinicalTrials.gov More Infections, Meningococcal trials

Plain-language summary

Who can participate

Age range

6 Weeks – 12 Weeks

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 at Day 1

Timeframe: Day 1 to Day 7

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

Timeframe: Day 1 to Day 7

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

Timeframe: Day 61 to Day 67

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

Timeframe: Day 61 to Day 67

Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121

Timeframe: Day 121 to Day 127

Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121

Timeframe: Day 121 to Day 127