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Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
This study is not yet open for participant recruitment.
Verified by Wyeth, November 2008
First Received: November 25, 2008   No Changes Posted
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00798304
  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 I
Phase II

MedlinePlus related topics: Meningitis
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Caregiver), Parallel Assignment, Safety/Efficacy Study
Official Title: Single-Blind, Randomized, Phase 1/2 Trial of the Safety, Tolerability, and Immunogenicity of Meningococcal Group B rLP2086 Vaccine in Healthy Infants

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 744
Study Start Date: January 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines
Biological: meningococcal B rLP2086 vaccine Biological: Routine age appropriate childhood vaccines
2: Experimental
Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines
Biological: meningococcal B rLP2086 vaccine Biological: Routine age appropriate childhood vaccines
3: Experimental
Dose level 3 of meningococcal B rLP2086 vaccine and routine childhood vaccines
Biological: meningococcal B rLP2086 vaccine Biological: Routine age appropriate childhood vaccines
4: Experimental
Dose level 4 of meningococcal B rLP2086 vaccine and routine childhood vaccines
Biological: meningococcal B rLP2086 vaccine Biological: Routine age appropriate childhood vaccines
5
Routine childhood vaccines
Biological: Routine age appropriate childhood vaccines

  Eligibility

Ages Eligible for Study:   42 Days to 98 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Main 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.

  1. Male or female subjects aged 2 months (42 to 98 days of age) at the time of enrollment.
  2. Available for the entire consented period and whose parent/legal guardian can be reached by telephone.
  3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
  4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Main Exclusion Criteria:

  1. 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:

  2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  3. Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus, rotavirus, varicella, measles, mumps, or rubella.
  4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  5. Known or suspected immune deficiency or suppression.
  6. History of culture-proven invasive disease caused by N meningitidis or Neisseria gonorrhoea.
  7. Major known congenital malformation or serious chronic disorder.
  8. 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.

  9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies).
  10. 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.
  11. Participation in purely observational studies is acceptable.
  12. Infant who is a direct descendant (child, grandchild) of the study site personnel.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798304

Contacts
Contact: Trial Manager clintrialparticipation@wyeth.com

Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

No publications provided

Responsible Party: Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers: 6108K2-2000
Study First Received: November 25, 2008
Last Updated: November 25, 2008
ClinicalTrials.gov Identifier: NCT00798304     History of Changes
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Wyeth:
Meningococcal B vaccine
infants
safety
immunogenicity

Study placed in the following topic categories:
Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Meningitis, Bacterial
Meningitis, Meningococcal
Central Nervous System Diseases
Meningococcal Infection
Healthy
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:
Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Meningitis, Bacterial
Nervous System Diseases
Central Nervous System Bacterial Infections
Meningitis, Meningococcal
Central Nervous System Diseases
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

ClinicalTrials.gov processed this record on May 07, 2009