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Trial record 1 of 1 for:    NCT00798304
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Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00798304
Recruitment Status : Terminated (Following program review within Pfizer, decision was made not to go ahead with this study. This study is cancelled)
First Posted : November 26, 2008
Results First Posted : November 26, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 25, 2008
First Posted Date  ICMJE November 26, 2008
Results First Submitted Date  ICMJE November 21, 2014
Results First Posted Date  ICMJE November 26, 2014
Last Update Posted Date November 26, 2014
Study Start Date  ICMJE January 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
  • 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
Immunogenicity as measured by serum bactericidal activity and total Ig levels to Meningococcal B vaccine.Safety and tolerability of the MnB vaccine as measured by frequency of solicited systemic events and local reactions and the occurence of AEs and SAE [ Time Frame: Approximately 7 months ]
Change History Complete list of historical versions of study NCT00798304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
Immunogenicity as measured by serum bactericidal activity and total Ig levels to Meningococcal B vaccine one month after the toddler dose [ Time Frame: Approximately 12 months ]
Current Other Pre-specified Outcome Measures
 (submitted: November 21, 2014)
  • 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 ]
  • 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 ]
  • 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 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
Official Title  ICMJE An Open Label, Randomized, Phase 1/2 Trial Of The Safety, Tolerability, And Immunogenicity Of Meningococcal Group B Rlp2086 Vaccine In Healthy Infants
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Meningitis, Meningococcal
Intervention  ICMJE
  • Biological: meningococcal B rLP2086 vaccine
    vaccination
  • Biological: Routine age appropriate childhood vaccines
    vaccination
Study Arms  ICMJE
  • Experimental: 1
    Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines
    Interventions:
    • Biological: meningococcal B rLP2086 vaccine
    • Biological: Routine age appropriate childhood vaccines
  • Experimental: 2
    Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines
    Interventions:
    • Biological: meningococcal B rLP2086 vaccine
    • Biological: Routine age appropriate childhood vaccines
  • Experimental: 3
    Control group
    Intervention: Biological: Routine age appropriate childhood vaccines
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 29, 2011)
46
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2008)
744
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00798304
Other Study ID Numbers  ICMJE 6108K2-2000
B1971008 ( Other Identifier: Alias Study Number )
2008-001457-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP