Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
NCT00161928
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- 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
- 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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Descriptive Information | ||||
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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 | 330 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | January 2003 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |