Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
Primary Purpose
Meningitis, Meningococcal
Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
meningococcal B rLP2086 vaccine
Routine age appropriate childhood vaccines
meningococcal B rLP2086 vaccine
Routine age appropriate childhood vaccines
Routine age appropriate childhood vaccines
Sponsored by
About this trial
This is an interventional prevention trial for Meningitis, Meningococcal focused on measuring Meningococcal B vaccine, infants, safety, immunogenicity
Eligibility 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.
Sites / Locations
- Hospital Clinico Universitario de Santiago
- Hospital Universitario de Mostóles
- Hospital Virgen del Camino
- Clínica Mediterráneo
- Hospital Gral. Gregorio Maranon
- Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes
- Hospital Xeral de Vigo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines
Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines
Control group
Outcomes
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
Percentage of Participants With at Least One Adverse Event (AE)
Secondary Outcome Measures
Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00798304
Brief Title
Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Following program review within Pfizer, decision was made not to go ahead with this study. This study is cancelled
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal
Keywords
Meningococcal B vaccine, infants, safety, immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines
Arm Title
2
Arm Type
Experimental
Arm Description
Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines
Arm Title
3
Arm Type
Experimental
Arm Description
Control group
Intervention Type
Biological
Intervention Name(s)
meningococcal B rLP2086 vaccine
Intervention Description
vaccination
Intervention Type
Biological
Intervention Name(s)
Routine age appropriate childhood vaccines
Intervention Description
vaccination
Intervention Type
Biological
Intervention Name(s)
meningococcal B rLP2086 vaccine
Intervention Description
vaccination
Intervention Type
Biological
Intervention Name(s)
Routine age appropriate childhood vaccines
Intervention Description
vaccination
Intervention Type
Biological
Intervention Name(s)
Routine age appropriate childhood vaccines
Intervention Description
vaccination
Primary Outcome Measure Information:
Title
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
Title
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)
Secondary Outcome Measure Information:
Title
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
Title
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
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
98 Days
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiado de Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario de Mostóles
City
Mostóles
State/Province
Madrid
ZIP/Postal Code
28935
Country
Spain
Facility Name
Hospital Virgen del Camino
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Clínica Mediterráneo
City
Almeria
ZIP/Postal Code
4007
Country
Spain
Facility Name
Hospital Gral. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Xeral de Vigo
City
Vigo
ZIP/Postal Code
36024
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25077420
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6108K2-2000&StudyName=Study%20Evaluating%20Safety%2C%20Tolerability%2C%20and%20Immunogenicity%20of%20Meningococcal%20B%20Vaccine%20in%20Healthy%20Infants
Description
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Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
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