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

NCT00798304

Last updated date
Study Location
Hospital Clinico Universitario de Santiago
Santiado de Compostela, La Coruña, 15706, Spain
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Meningococcal MeningitisA Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
NCT00808028
  1. Herston, Queensland
  2. North Adelaide, South Australia
  3. Carlton, Victoria
  4. Subiaco, Western Australia
  5. Debica,
  6. Krakow,
  7. Krakow,
  8. Leczna,
  9. Lodz,
  10. Lodz,
  11. Lubartow,
  12. Lublin,
  13. Melno,
  14. Oborniki Slaskie,
  15. Poznan,
  16. Siemianowice Slaskie,
  17. Torun,
  18. Trzebnica,
  19. Wroclaw,
  20. Wroclaw,
  21. Santiago de Compostela, La Coruna
  22. Getafe, Madrid
  23. Vigo, Pontevedra
  24. Almeria,
  25. Barcelona,
  26. Madrid,
  27. Valencia,
ALL GENDERS
11 Years+
years
MULTIPLE SITES
Meningococcal MeningitisStudy Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
NCT00879814
  1. South Miami, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Meningococcal MeningitisStudy Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
NCT00798304
  1. Santiado de Compostela, La Coruña
  2. Mostóles, Madrid
  3. Pamplona, Navarra
  4. Almeria,
  5. Madrid,
  6. Madrid,
  7. Vigo,
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Meningococcal MeningitisStudy of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
NCT00161928
  1. Linz,
  2. Wels,
  3. Augsburg,
  4. Bad Saulgau,
  5. Berlin,
  6. Bietigheim-Bissingen,
  7. Ettenheim,
  8. Heilbronn,
  9. Kehl,
  10. Nördlingen,
  11. Oberndorf / Neckar,
  12. Offenburg,
  13. Roding,
  14. Weingarten,
ALL GENDERS
2 Months+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
Official Title  ICMJE An Open Label, Randomized, Phase 1/2 Trial Of The Safety, Tolerability, And Immunogenicity Of Meningococcal Group B Rlp2086 Vaccine In Healthy Infants
Brief Summary The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Meningitis, Meningococcal
Intervention  ICMJE
  • Biological: meningococcal B rLP2086 vaccine
    vaccination
  • Biological: Routine age appropriate childhood vaccines
    vaccination
Study Arms  ICMJE
  • Experimental: 1
    Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines
    Interventions:
    • Biological: meningococcal B rLP2086 vaccine
    • Biological: Routine age appropriate childhood vaccines
  • Experimental: 2
    Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines
    Interventions:
    • Biological: meningococcal B rLP2086 vaccine
    • Biological: Routine age appropriate childhood vaccines
  • Experimental: 3
    Control group
    Intervention: Biological: Routine age appropriate childhood vaccines
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 29, 2011)
46
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2008)
744
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00798304
Other Study ID Numbers  ICMJE 6108K2-2000
B1971008 ( Other Identifier: Alias Study Number )
2008-001457-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP