Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants

Phase 2

Terminated

• Conditions: Meningitis, Meningococcal
• Interventions: Biological: meningococcal B rLP2086 vaccine; Biological: Routine age appropriate childhood vaccines

• Registration Number: NCT00798304
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-26
• Study Start: 2009-01
• Primary Completion: 2009-06
• Study Completion: 2009-09
• Status Verified: 2014-11
• Results First Submitted: 2014-11-21
• Results First Submitted QC: 2014-11-21
• Last Update Submitted: 2014-11-21
• Results First Posted: 2014-11-26
• Last Update Posted: 2014-11-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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.

• Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies).
• 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.
• Participation in purely observational studies is acceptable.
• Infant who is a direct descendant (child, grandchild) of the study site personnel.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Routine age appropriate childhood vaccines	Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines
3	Routine age appropriate childhood vaccines	Control group
2	meningococcal B rLP2086 vaccine	Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines
1	Routine age appropriate childhood vaccines	Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines
1	meningococcal B rLP2086 vaccine	Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines

Primary Outcome Measures

Name	Time	Method
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	1 month after Dose 3
Percentage of Participants With at Least One Adverse Event (AE)	From signing of informed consent form to completion of study (up to 2 years)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Hospital Virgen del Camino; 🇪🇸 Pamplona, Navarra, Spain

Hospital Clinico Universitario de Santiago; 🇪🇸 Santiado de Compostela, La Coruña, Spain

Hospital Universitario de Mostóles; 🇪🇸 Mostóles, Madrid, Spain

Hospital Gral. Gregorio Maranon; 🇪🇸 Madrid, Spain

Clínica Mediterráneo; 🇪🇸 Almeria, Spain

Hospital Xeral de Vigo; 🇪🇸 Vigo, Spain

Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes; 🇪🇸 Madrid, Spain