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| Sponsor: | Novartis |
|---|---|
| Collaborator: |
Novartis Vaccines |
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00806195 |
Purpose
The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants
| Condition | Intervention | Phase |
|---|---|---|
|
Meningitis Meningococcal Infection |
Biological: MenACWY Biological: Concomitants Biological: MenACWY - Detailed safety Biological: Concomitants - Detailed safety |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants |
| Estimated Enrollment: | 7700 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | November 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: MenACWY
4 vaccinations of Men ACWY at 2, 4, 6 and 12 month of age plus concomitant routine vaccinations (according to the local vaccination schedule) For subjects enrolled in the US, concomitant vaccines administered at each visit will be consistent with the US ACIP recommended vaccines. At 2, 4 and 6 months of age subjects will receive, at a minimum, vaccinations containing:
At 12 months of age subjects will receive, at a minimum, vaccinations containing:
At 15 months of age subjects will receive, at a minimum, vaccinations containing:
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2
Concomitants
|
Biological: Concomitants
Routine vaccinations (according to the local vaccination schedule) For subjects enrolled in the US, concomitant vaccines administered at each visit will be consistent with the US ACIP recommended vaccines. At 2, 4 and 6 months of age subjects will receive, at a minimum, vaccinations containing:
At 12 months of age subjects will receive, at a minimum, vaccinations containing:
At 15 months of age subjects will receive, at a minimum, vaccinations containing:
|
| Experimental: 3 |
Biological: MenACWY - Detailed safety
4 vaccinations of Men ACWY at 2, 4, 6 and 12 month of age plus concomitant routine vaccinations (according to the local vaccination schedule) Concomitant vaccinations given to subjects in these arms will be consistent with the US ACIP recommended vaccines. At 2, 4 and 6 months of age subjects will receive, at a minimum, the following vaccinations:
HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. At 12 months of age, subjects will receive, at a minimum, the following vaccinations
At 15 months of age, subjects will receive, at a minimum, the following vaccinations:
|
|
4
Concomitants
|
Biological: Concomitants - Detailed safety
Routine vaccinations (according to the local vaccination schedule) Concomitant vaccinations given to subjects in these arms will be consistent with the US ACIP recommended vaccines. At 2, 4 and 6 months of age subjects will receive, at a minimum, the following vaccinations:
HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. At 12 months of age, subjects will receive, at a minimum, the following vaccinations
At 15 months of age, subjects will receive, at a minimum, the following vaccinations:
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Eligibility| Ages Eligible for Study: | 2 Months to 2 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
who have a known or suspected autoimmune disease or persistent impairment/alteration of immune function resulting from (for example):
Contacts and Locations
Show 125 Study Locations
More Information
| Responsible Party: | Novartis, Novartis Vaccines |
| ClinicalTrials.gov Identifier: | NCT00806195 History of Changes |
| Other Study ID Numbers: | V59P23 |
| Study First Received: | December 9, 2008 |
| Last Updated: | June 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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vaccine infants healthy meningitis meningococcal |
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Meningitis Meningococcal Infections Central Nervous System Infections Central Nervous System Diseases |
Nervous System Diseases Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |