Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants

NCT00161928

Last updated date
Study Location
Freistädter Strasse 290
Linz, , 4040, Austria
Contact
1-800-718-1021

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1-800-718-1021

By email

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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
2-6 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female volunteers infants, aged 2 to 6 months

- Clinically healthy, (i.e. the physician would have no reservations vaccinating with a meningococcal C vaccine outside the scope of a clinical trial)

- Parent(s)/legal guardian understands the study and has provided written informed consent for his/her infant's study participation

- Parent(s)/legal guardian and infant will be available for the duration of the study

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


- History of any vaccine-related contraindicating event (e.g. anaphylaxis)


- Rash or other dermatological condition at the injection site which could interfere
with injection site reaction monitoring or lead to a dermatological reaction


- Subjects who have received or will receive other vaccine(s) ± 30 days before or after
the study period


- Concurrent participation in or previous participation in a clinical trial with an
investigational medicinal product


- Subjects who suffer from a disease (e.g. autoimmune disease) or are undergoing a form
of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected
to influence immunological functions


- Subjects who have previously received a vaccination against Hep B or meningococcal C


- Subjects who have received banked human blood or immunoglobulins within one month of
study entry

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
Official Title  ICMJE A Randomized, Open-Label Trial of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
Brief Summary The primary aim of the study is to show that NeisVac-C does not influence the seroconversion rates induced by hepatitis B (Hep B), inactivated polio (IPV) and acellular pertussis (aP) vaccines in infants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Meningitis, Meningococcal
Intervention  ICMJE Biological: Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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 Completed
Enrollment  ICMJE
 (submitted: September 12, 2005)
330
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female volunteers infants, aged 2 to 6 months
  • Clinically healthy, (i.e. the physician would have no reservations vaccinating with a meningococcal C vaccine outside the scope of a clinical trial)
  • Parent(s)/legal guardian understands the study and has provided written informed consent for his/her infant's study participation
  • Parent(s)/legal guardian and infant will be available for the duration of the study

Exclusion Criteria:

  • History of any vaccine-related contraindicating event (e.g. anaphylaxis)
  • Rash or other dermatological condition at the injection site which could interfere with injection site reaction monitoring or lead to a dermatological reaction
  • Subjects who have received or will receive other vaccine(s) ± 30 days before or after the study period
  • Concurrent participation in or previous participation in a clinical trial with an investigational medicinal product
  • Subjects who suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
  • Subjects who have previously received a vaccination against Hep B or meningococcal C
  • Subjects who have received banked human blood or immunoglobulins within one month of study entry
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Months to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161928
Other Study ID Numbers  ICMJE 216
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator:Baxter BioScience InvestigatorBaxter Healthcare Corporation
PRS Account Pfizer
Verification Date May 2015

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