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

NCT ID: NCT00798304

Last Updated: 2014-11-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

Brief Summary

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The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.

Detailed Description

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Conditions

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Meningitis, Meningococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines

Group Type EXPERIMENTAL

meningococcal B rLP2086 vaccine

Intervention Type BIOLOGICAL

vaccination

Routine age appropriate childhood vaccines

Intervention Type BIOLOGICAL

vaccination

2

Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines

Group Type EXPERIMENTAL

meningococcal B rLP2086 vaccine

Intervention Type BIOLOGICAL

vaccination

Routine age appropriate childhood vaccines

Intervention Type BIOLOGICAL

vaccination

3

Control group

Group Type EXPERIMENTAL

Routine age appropriate childhood vaccines

Intervention Type BIOLOGICAL

vaccination

Interventions

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meningococcal B rLP2086 vaccine

vaccination

Intervention Type BIOLOGICAL

Routine age appropriate childhood vaccines

vaccination

Intervention Type BIOLOGICAL

meningococcal B rLP2086 vaccine

vaccination

Intervention Type BIOLOGICAL

Routine age appropriate childhood vaccines

vaccination

Intervention Type BIOLOGICAL

Routine age appropriate childhood vaccines

vaccination

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

42 Days

Maximum Eligible Age

98 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Clínica Mediterráneo

Almería, Almeria, Spain

Site Status

Hospital Clinico Universitario de Santiago

Santiado de Compostela, La Coruña, Spain

Site Status

Hospital Gral. Gregorio Maranon

Madrid, Madrid, Spain

Site Status

Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes

Madrid, Madrid, Spain

Site Status

Hospital Universitario de Mostóles

Mostóles, Madrid, Spain

Site Status

Hospital Virgen del Camino

Pamplona, Navarre, Spain

Site Status

Hospital Xeral de Vigo

Vigo, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 25077420 (View on PubMed)

Related Links

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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

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1971008

Identifier Type: OTHER

Identifier Source: secondary_id

2008-001457-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

6108K2-2000

Identifier Type: -

Identifier Source: org_study_id