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

This study has been terminated.
(Following program review within Pfizer, decision was made not to go ahead with this study. This study is cancelled)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00798304
First received: November 25, 2008
Last updated: November 21, 2014
Last verified: November 2014
  Purpose
The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.

Condition Intervention Phase
Meningitis, Meningococcal
Biological: meningococcal B rLP2086 vaccine
Biological: Routine age appropriate childhood vaccines
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open Label, Randomized, Phase 1/2 Trial Of The Safety, Tolerability, And Immunogenicity Of Meningococcal Group B Rlp2086 Vaccine In Healthy Infants

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain [ Time Frame: 1 month after Dose 2, Dose 3; before Dose 4 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1 month after Dose 2, Dose 3; before Dose 4 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percentage of Participants Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer [ Time Frame: 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4 ] [ Designated as safety issue: No ]
  • Serum Bactericidal Assay (SBA) GMTs for Additional MnB Test Strains [ Time Frame: 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4 ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: January 2009
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   42 Days to 98 Days   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798304

Locations
Spain
Hospital Clinico Universitario de Santiago
Santiado de Compostela, La Coruña, Spain, 15706
Hospital Universitario de Mostóles
Mostóles, Madrid, Spain, 28935
Hospital Virgen del Camino
Pamplona, Navarra, Spain, 31008
Clínica Mediterráneo
Almeria, Spain, 4007
Hospital Gral. Gregorio Maranon
Madrid, Spain, 28007
Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes
Madrid, Spain, 28041
Hospital Xeral de Vigo
Vigo, Spain, 36024
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00798304     History of Changes
Other Study ID Numbers: 6108K2-2000  B1971008  2008-001457-18 
Study First Received: November 25, 2008
Results First Received: November 21, 2014
Last Updated: November 21, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Pfizer:
Meningococcal B vaccine
infants
safety
immunogenicity

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2016