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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Hospital Clinico Universitario de Santiago
Santiado de Compostela, La Coruña, 15706 Spain
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Meningitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-98 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00798304
Pfizer
Terminated
Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants

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Not Provided
Interventional
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Intervention Model: Parallel Assignment
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Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
46
September 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
42 Days to 98 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00798304
6108K2-2000
B1971008 ( Other Identifier: Alias Study Number )
2008-001457-18 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]



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