Status:
COMPLETED
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Lead Sponsor:
Novartis Vaccines
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Serogroup B Meningococcal Meningitis
Eligibility:
All Genders
55-89 years
Phase:
PHASE3
Brief Summary
The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant va...
Eligibility Criteria
Inclusion
- Healthy 2-month old infants (55-89 days, inclusive)
Exclusion
- Prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens)
- 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 or alteration of the immune system
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
3630 Patients enrolled
Trial Details
Trial ID
NCT00657709
Start Date
March 1 2008
End Date
January 1 2010
Last Update
October 10 2017
Active Locations (66)
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1
Grässl
Hall in Tirol, Austria, 6060
2
Häckel
Kirchdorf, Austria, 4560
3
Prieler
Neufeld A.d. Leitha, Austria, 2491
4
Maurer
Salzburg, Austria, 5020