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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Freistädter Strasse 290
Linz, , 4040 Austria
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
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

NCT00161928
Pfizer
Completed
Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants

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Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Meningitis, Meningococcal
Biological: Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
January 2003
Not Provided

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
Sexes Eligible for Study: All
2 Months to 6 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
 
NCT00161928
216
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation
Pfizer
May 2015

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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