| January 31, 2008 |
| October 22, 2009 |
| February 2008 |
| January 2009 (final data collection date for primary outcome measure) |
| To evaluate safety and immune response across groups at pre-defined time points [ Time Frame: 1 month ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00616421 on ClinicalTrials.gov Archive Site |
| To further evaluate safety and immunogencity across groups at pre-defined time points [ Time Frame: 2 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children |
| A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age |
This study will evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY conjugate vaccine |
| |
| Phase III |
| Interventional |
| Prevention, Randomized, Single Blind (Subject), Single Group Assignment |
| Meningococcal Infections |
| Biological: MenACWY |
- Experimental: Children 2-5 years of age, 1 dose of MenACWY
- Active Comparator: Children 2-5 years of age, 1 dose of MenACWY
- Experimental: Children 6-10 years of age, 1 dose of MenACWY
- Active Comparator: Children 6-10 years of age, 1 dose of MenACWY
- Experimental: Children 2-5 years of age, Men ACWY Day 1 and Men ACWY Day 61
|
| |
| |
| Active, not recruiting |
| 2820 |
|
| January 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
- who are available for all visits and telephone calls scheduled for the study
- who are up-to-date with age-appropriate routine childhood vaccinations
Exclusion Criteria:
- whose parent or legal guardian is unwilling or unable to give written informed consent
- who had a previous or suspected disease caused by N. meningitidis;
- who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- who have received any investigational agents or vaccines within 90 days prior to enrollment
- who have any serious acute, chronic or progressive disease
- who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
- who have a history of anaphylaxis, serious vaccine reactions
- who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
- who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
- who have Down's syndrome or other known cytogenic disorders
|
| Both |
| 2 Years to 10 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada |
| |
| NCT00616421 |
| Novartis, Novartis Vaccines |
| V59P20, 11278 |
| Novartis |
| Novartis Vaccines |
| Study Chair: |
Novartis Vaccines |
Novartis Vaccines |
|
|
| Novartis |
| October 2009 |