A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
Status: | Completed |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 10/14/2017 |
Start Date: | March 2007 |
End Date: | November 2009 |
A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY
conjugate vaccine when administered with routine infant vaccinations to healthy infants.
conjugate vaccine when administered with routine infant vaccinations to healthy infants.
Inclusion Criteria:
- Healthy term 2-month-old infants for whom a parent/legal representative has given
written informed consent.
Exclusion Criteria:
- Subjects with a previous or suspected disease caused by Neisseria meningitidis,
Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus
influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization
with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior
vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated
polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus;
who have had household contact with and/or intimate exposure to an individual with
laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis,
Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any
serious acute, chronic or progressive disease
We found this trial at
54
sites
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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2054 South Green Road
Cleveland, Ohio 44118
Cleveland, Ohio 44118
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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