CompletedPhase 2

A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years

Finland, Poland400 participantsStarted 2015-08

Plain-language summary

This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young children. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Who can participate

Age range

24 Months – 10 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

. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject's parent(s)/legal guardian has been informed of all pertinent aspects of the study.
. Parent(s)/legal guardian and subject who are willing and able to comply with scheduled visits, vaccine regimen, laboratory tests, and other study procedures.
. Male or female subjects aged ≥24 months and \<10 years at time of randomization, stratified equally by age (≥24 months to \<4 years or ≥4 years to \<10 years).
. Subject is available for the entire study period and subject's parent(s)/legal guardian can be reached by telephone.
. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
. Subject must have received all vaccinations in the relevant national immunization program (NIP) for their age group.

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

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3

Timeframe: 1 month after Vaccination 3

Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1

Timeframe: Within 7 Days after Vaccination 1

Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2

Timeframe: Within 7 Days after Vaccination 2

Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3

Timeframe: Within 7 Days after Vaccination 3

Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1

Timeframe: Within 7 Days after Vaccination 1

Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2

Timeframe: Within 7 Days after Vaccination 2

Trial details

NCT IDNCT02531698

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-03

Results submitted2018-02-28

View on ClinicalTrials.gov More MENINGOCOCCAL INFECTION trials

Who can participate

Age range

24 Months – 10 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

. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject's parent(s)/legal guardian has been informed of all pertinent aspects of the study.
. Parent(s)/legal guardian and subject who are willing and able to comply with scheduled visits, vaccine regimen, laboratory tests, and other study procedures.
. Male or female subjects aged ≥24 months and \<10 years at time of randomization, stratified equally by age (≥24 months to \<4 years or ≥4 years to \<10 years).
. Subject is available for the entire study period and subject's parent(s)/legal guardian can be reached by telephone.
. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
. Subject must have received all vaccinations in the relevant national immunization program (NIP) for their age group.

What they're measuring

Timeframe: 1 month after Vaccination 3

Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1

Timeframe: Within 7 Days after Vaccination 1

Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2

Timeframe: Within 7 Days after Vaccination 2

Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3

Timeframe: Within 7 Days after Vaccination 3

Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1

Timeframe: Within 7 Days after Vaccination 1

Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2

Timeframe: Within 7 Days after Vaccination 2

A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria