Status:
COMPLETED
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12
Lead Sponsor:
Novartis Vaccines
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Meningococcal Disease
Meningococcal Meningitis
Eligibility:
All Genders
12-24 years
Phase:
PHASE2
PHASE3
Brief Summary
This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with ...
Eligibility Criteria
Inclusion
- Follow-on participants of V72P12:
- Healthy toddlers who completed Study V72P12, aged:
- 12 months or older - Groups 1a, 2a, 3a, 4
- 18 months (0/ +29 days window) - Groups 1b, 2b, 3b
- 24 months (0/ +29 days window) - Groups 1c, 2c, 3c
- Naive subjects newly enrolled:
- Group 5: healthy 18-month-old toddlers (0/ +29 days window)
- Group 6: healthy 24-month-old toddlers (0/ +29 days window)
Exclusion
- History of any meningococcal B vaccine administration (only for groups 5 and 6);
- 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 to 38 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 :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
1588 Patients enrolled
Trial Details
Trial ID
NCT00944034
Start Date
July 1 2009
End Date
January 1 2012
Last Update
August 14 2017
Active Locations (72)
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1
Avenue Albert 1er 185, 5000 Namur, Belgium
2
Avenue Hippocrate 10, 1200 Brussels, Belgium
3
Laarbeeklaan 101, 1090 Brussels, Belgium
4
Lindendreef 1, 2020 Antwerpen, Belgium