An Open Label, Randomized, Phase 1/2 Trial Of The Safety, Tolerability, And Immunogenicity Of Meningococcal Group B Rlp2086 Vaccine In Healthy Infants

Pfizer7 sites in 1 country46 target enrollmentJanuary 2009

ConditionsMeningitis, Meningococcal

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Meningitis, Meningococcal
Sponsor: Pfizer
Enrollment: 46
Locations: 7
Primary Endpoint: Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

September 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Investigators should always use good clinical judgment in considering a subject's overall fitness for trial participation. In addition, any condition that in the opinion of the investigator may interfere with the evaluation of study objectives should be carefully considered prior to enrolling subjects.
•Male or female subjects aged 2 months (42 to 98 days of age) at the time of enrollment.
•Available for the entire consented period and whose parent/legal guardian can be reached by telephone.
•Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
•Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion Criteria

•Previous vaccination with licensed or investigational vaccines: meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, poliovirus, rotavirus, varicella, measles, mumps, or rubella.
•Any of the following illnesses/conditions that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study:
•A previous anaphylactic reaction to any vaccine or vaccine-related component.
•Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus, rotavirus, varicella, measles, mumps, or rubella.
•Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
•Known or suspected immune deficiency or suppression.
•History of culture-proven invasive disease caused by N meningitidis or Neisseria gonorrhoea.
•Major known congenital malformation or serious chronic disorder.
•Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder.
•Does not include resolving syndromes due to birth trauma such as Erb palsy.

Outcomes

Primary Outcomes

Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain

Time Frame: 1 month after Dose 3

Percentage of Participants With at Least One Adverse Event (AE)

Time Frame: From signing of informed consent form to completion of study (up to 2 years)

Secondary Outcomes

Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain(1 month after Dose 2, Dose 3; before Dose 4)
Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain(1 month after Dose 2, Dose 3; before Dose 4)