Status:
COMPLETED
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
Lead Sponsor:
Novartis Vaccines
Conditions:
Meningococcal Infections
Eligibility:
All Genders
55-89 years
Phase:
PHASE2
Brief Summary
Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4 months of age, as measured...
Eligibility Criteria
Inclusion
- Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
- For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained.
Exclusion
- History of any meningococcal B or C vaccine administration;
- 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;
- Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to38 degrees within the previous day;
- Antibiotics within 6 days prior to enrollment;
- Any serious chronic or progressive disease;
- Known or suspected impairment or alteration of the immune system;
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
1885 Patients enrolled
Trial Details
Trial ID
NCT00721396
Start Date
August 1 2008
End Date
July 1 2010
Last Update
March 23 2015
Active Locations (60)
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1
Novartis Investigational Site Nr. 59
Edegem, Antwerpen, Belgium, 2650
2
Novartis Investigational Site Nr. 55
Antwerp, Antwerp, Belgium, 2018
3
Study Investigational Site Nr. 60
Brussels, Brussels Capital, Belgium, 1090
4
Novartis Investigational Site Nr. 57
Brussels, Brussels Capital, Belgium, 1200