Single-blind, Randomized, Phase 1/2 Trial of the Safety, Tolerability, and Immunogenicity of Meningococcal Group B rLP2086 Vaccine in Healthy Infants

• Conditions: Healthy infant vaccination against Meningitis B; MedDRA version: 9.1Level: LLTClassification code 10027202Term: Meningitis bacterial

• Registration Number: EUCTR2008-001457-18-ES
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female subjects aged 2 months (42 to 98 days of age) at the time of enrollment.
2. Available for the entire consented period and whose parent/legal guardian can be reached by telephone.
3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous vaccination with licensed or investigational vaccines: meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), 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:
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3.Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus, rotavirus, varicella, measles, mumps, or rubella.
4.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by N meningitidis or Neisseria gonorrhoea.
7. Major known congenital malformation or serious chronic disorder.
8. 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.
9.Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies).
10.Received any investigational drugs, vaccines or devices (aside from those specified in the protocol) within 4 weeks before administration of the first dose of test article or at any time throughout the study.
11.Participation in purely observational studies is acceptable.
12.Infant who is a direct descendant (child, grandchild) of the study site personnel.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the immunogenicity of 60 ?g, 120 µg and 200 ?g of rLP2086 as measured by serum bactericidal assay (SBA) to MnB strains expressing LP2086 subfamily A and B proteins in healthy infants 1 month after the infant series.;Primary end point(s): Safety endpoint: adverse events, local and systemic reactions<br>Immunogenicity endpoint: MnB rLP2086 specific Ig levels + SBA titers;Secondary Objective: To assess the immunogenicity of 60 ?g, 120 µg, and 200 ?g of rLP2086 as measured by serum bactericidal assay (SBA to MnB strains expressing LP2086 subfamily A and B proteins in healthy toddlers 1 month after the toddler dose.<br><br>To assess the immunogenicity of 60 µg, 120 µg, and 200 µg of rLP2086 as determined by quantitation of serum immunoglobulin (Ig) binding to rLP2086 vaccine A and B proteins in healthy infants/toddlers 1 month after the infant series and 1 month after the toddler dose.