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

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

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

Study Overview

• Status: Terminated
• Conditions: Meningitis, Meningococcal
• Intervention / Treatment: Biological: meningococcal B rLP2086 vaccine; Biological: Routine age appropriate childhood vaccines

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Almeria, Spain, 4007
    • Clínica Mediterráneo
  • Madrid, Spain, 28007
    • Hospital Gral. Gregorio Maranon
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes
  • Vigo, Spain, 36024
    • Hospital Xeral de Vigo
  • La Coruña
    • Santiado de Compostela, La Coruña, Spain, 15706
      • Hospital Clinico Universitario de Santiago
  • Madrid
    • Mostóles, Madrid, Spain, 28935
      • Hospital Universitario de Mostoles
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital Virgen del Camino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines	Biological: meningococcal B rLP2086 vaccine; vaccination; Biological: Routine age appropriate childhood vaccines; vaccination
Experimental: 2; Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines	Biological: meningococcal B rLP2086 vaccine; vaccination; Biological: Routine age appropriate childhood vaccines; vaccination
Experimental: 3; Control group	Biological: Routine age appropriate childhood vaccines; vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer	1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
Percentage of Participants Achieving SBA Titer Levels >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Additional MnB Test Strains	1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
Serum Bactericidal Assay (SBA) GMTs for Additional MnB Test Strains	1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Martinon-Torres F, Gimenez-Sanchez F, Bernaola-Iturbe E, Diez-Domingo J, Jiang Q, Perez JL. A randomized, phase 1/2 trial of the safety, tolerability, and immunogenicity of bivalent rLP2086 meningococcal B vaccine in healthy infants. Vaccine. 2014 Sep 8;32(40):5206-11. doi: 10.1016/j.vaccine.2014.07.049. Epub 2014 Jul 29.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: November 25, 2008
• First Submitted That Met QC Criteria: November 25, 2008
• First Posted (Estimate): November 26, 2008

Study Record Updates

• Last Update Posted (Estimate): November 26, 2014
• Last Update Submitted That Met QC Criteria: November 21, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: safety; infants; immunogenicity; Meningococcal B vaccine
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Meningitis, Meningococcal; Meningitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 6108K2-2000; B1971008 (Other Identifier: Alias Study Number); 2008-001457-18 (EudraCT Number)