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

Finland400 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 range24 Months – 10 Years

SexALL

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.
✓. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
✓. Negative urine pregnancy test for all female subjects who are biologically capable of having children.

Exclusion criteria

✕. Previous vaccination with any meningococcal serogroup B vaccine.
✕. Subjects who have received prior HAV vaccination.

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

Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3

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 range24 Months – 10 Years

SexALL

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.
✓. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
✓. Negative urine pregnancy test for all female subjects who are biologically capable of having children.

Exclusion criteria

✕. Previous vaccination with any meningococcal serogroup B vaccine.
✕. Subjects who have received prior HAV vaccination.

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

Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3