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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00798304 |
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 |
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Meningitis, Meningococcal |
Biological: meningococcal B rLP2086 vaccine Biological: Routine age appropriate childhood vaccines |
Phase I Phase II |
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 |
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 |
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1: Experimental
Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines
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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
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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
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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
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Biological: meningococcal B rLP2086 vaccine Biological: Routine age appropriate childhood vaccines |
5
Routine childhood vaccines
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Biological: Routine age appropriate childhood vaccines |
Ages Eligible for Study: | 42 Days to 98 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
Main 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:
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.
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Study Director: | Medical Monitor | Wyeth |
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 |
Meningococcal B vaccine infants safety immunogenicity |
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 |
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 |