Status:
COMPLETED
Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers
Lead Sponsor:
Novartis Vaccines
Conditions:
Meningococcal Disease
Eligibility:
All Genders
365-394 years
Phase:
PHASE3
Brief Summary
The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months o...
Eligibility Criteria
Inclusion
- Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13
Exclusion
- Previous ascertained or suspected disease caused by N. meningitidis;
- History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- Any serious chronic or progressive disease
- Known or suspected impairment/ alteration of the immune system,
- Receipt of, or intent to immunize with another vaccine, within 30 days prior to enrollment.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
2249 Patients enrolled
Trial Details
Trial ID
NCT00847145
Start Date
February 1 2009
End Date
August 1 2010
Last Update
March 3 2015
Active Locations (59)
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1
Altenburger
Eisenstadt, Austria, 7000
2
Grässl
Hall in Tirol, Austria, 6060
3
Häckel
Kirchdorf, Austria, 4560
4
Prieler
Neufeld A.d. Leitha, Austria, 2491