Persistence of Antibody Response to N. Meningitidis Group C in Children
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ClinicalTrials.gov Identifier: NCT00316654 |
Recruitment Status
:
Completed
First Posted
: April 21, 2006
Last Update Posted
: July 25, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prevention of Meningococcal Infection | Biological: Meningococcal C conjugate vaccine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 489 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Phase IV,Multi-Center,Open-Label,Unrandomized Study to Evaluate the Persistence of Antibody Response to N.Meningitidis Group C,Before & After 2 Doses of the Conjugate Pneumococcal Vaccine,in Children Seven Months & Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine & a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |

- Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA
- Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
- safety and tolerability

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Ages Eligible for Study: | 7 Months and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy children
Exclusion Criteria:
- previous ascertained or suspected disease caused by N. meningitidis
- previous significant acute or chronic infections
- any other serious disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316654
Poland | |
Olsztyn, Lubartów, Kielce, Kraków, Bydgoszcz, Poland | |
Spain | |
Valencia, Spain |
Principal Investigator: | Novartis Vaccines Drug Information Services | Novartis Vaccines & Diagnostics |
Responsible Party: | Novartis Vaccines |
ClinicalTrials.gov Identifier: | NCT00316654 History of Changes |
Other Study ID Numbers: |
V14P38E1 2004-001522-24 ( EudraCT Number ) |
First Posted: | April 21, 2006 Key Record Dates |
Last Update Posted: | July 25, 2017 |
Last Verified: | July 2017 |
Keywords provided by Novartis ( Novartis Vaccines ):
Prevention of Meningococcal Meningitis vaccines, conjugate immunology child antibody persistence |
Additional relevant MeSH terms:
Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Vaccines |
Antibodies Immunoglobulins Immunologic Factors Physiological Effects of Drugs |