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

Meningococcal Disease Clinical Trial

Official title:

A Phase 3, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847145
• Other study ID #: V72P13E1
• Secondary ID: 2008-006301-17
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2009
• Last updated: March 2, 2015
• Start date: February 2009
• Est. completion date: August 2010

Study information

• Verified date: March 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationItaly: AIFAFinland: NAMGermany: PEICzech Republic: SUKLAustria: Austrian Federal Agency for Safety in Health Care (BSAG)
• Study type: Interventional

Clinical Trial 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 of Age or as a Two-dose Catch-up to Healthy Toddlers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2249
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 365 Days to 394 Days

Eligibility

Inclusion Criteria:

• Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• 1a - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and routine vaccine at study month 12.
• 1b - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.
• 2a - Routine and rMenB+OMV NZ vaccines
One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
• 2b - rMenB+OMV NZ and routine vaccines
Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
• 3a - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
• 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.
• 4a- rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
• 4b - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

Locations

Country	Name	City	State
Austria	Altenburger	Eisenstadt
Austria	Grässl	Hall in Tirol
Austria	Häckel	Kirchdorf
Austria	Prieler	Neufeld a.d. Leitha
Austria	Maurer	Salzburg
Austria	Angermayr	Wels
Austria	Sommer	Wien
Czech Republic	Site 27	Boskovice
Czech Republic	Site 19	Brno
Czech Republic	Site 22	Chomutov
Czech Republic	Site 12	Havlíckuv Brod
Czech Republic	Fakulta vojenskeho zdravotnictví	Hradec Králové
Czech Republic	Site 28	Hranice I-mesto
Czech Republic	Site 13	Humpolec
Czech Republic	Site 25	Kladno 2
Czech Republic	Site 21	Kolín
Czech Republic	Site 10	Liberec
Czech Republic	Site 24	Litomerice
Czech Republic	Site 17	Ostrava
Czech Republic	Site 18	Ostrava-Poruba
Czech Republic	Site 16	Plzen
Czech Republic	Site 26	Rumburk
Czech Republic	Site 23	Usti nad Labem
Finland	Site 30	Espoo
Finland	Site 31	Helsinki
Finland	Site 32	Helsinki
Finland	Site 34	Järvenpää
Finland	Site 35	Kokkola
Finland	Site 45	Kotka
Finland	Site 46	Kuopio
Finland	Site 47	Lahti
Finland	Site 49	Oulu
Finland	Site 50	Pori
Finland	Site 51	Seinäjoki
Finland	Site 52	Tampere
Finland	Site 53	Turku
Finland	Site 33	Vantaa
Finland	Site 48	Vantaa
Germany	Site 99	Detmold
Germany	Site 92	Espelkamp
Germany	Site 95	Freising
Germany	Site 64	Fulda
Germany	Site 58	Lauffen
Germany	Site 57	Marbach a. N.
Germany	Site 91	Munchen
Germany	Site 80	München
Germany	Site 83	München
Germany	Site 96	München
Germany	Site 97	München
Germany	Site 81	Porta Westfalica
Germany	Site 65	Schwieberdingen
Germany	Site 94	Weilheim
Italy	Dipartimento di Scienze della Salute	Genova
Italy	Universita degli Studi di Messina, Policlinico G. Martino	Messina
Italy	Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia	Milano
Italy	Pediatria dell' Ospedale Sacco	Milano
Italy	Ospedale Maggiore di Novara	Novara
Italy	Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari	Sassari
Italy	ASL/TA	Taranto

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

Austria,  Czech Republic,  Finland,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages of Subjects With Serum Bactericidal Antibody Titers =1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination	Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers =1:5 the lower limit of the two-sided 95% confidence interval (CI) was =75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.	one month after the booster (fourth) dose	No
Secondary	Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination	Immunogenicity was assessed to demonstrate non-inferiority in terms of percentages of subjects as measured by antibody responses against MMRV vaccine when given concomitantly with the booster (fourth) dose of rMenB+OMV NZ vaccine at 12 months of age when compared to MMRV vaccine when given alone.; The specified cut-off levels for the vaccine antigens : for measles antigen is =255mIU/mL, Mumps antigen is =10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody(Ab) units, Rubella antigen is =10 IU/mL, Varicella antigen is =1.25 glycoprotein (gp) ELISA units/ml (seroconversion) and varicella antigen is =5 gp ELISA units/ml (seroprotection.	one month after booster (fourth) dose	Yes
Secondary	The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination	The human serum bactericidal antibody (hSBA) titer responses, one month after receiving booster dose or rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).	one month after booster (fourth) vaccination.	No
Secondary	Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)	The immunogenicity was assessed as the persistence of bactericidal antibodies at 12 months of age (pre-dose 4) who previously received three doses of rMenB+OMV NZ in the parent study as measured by hSBA GMTs directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.	one month after third vaccination and pre dose fourth (booster) vaccination	No
Secondary	Percentages of Subjects With Serum Bactericidal Antibody Titers =1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)	Immunogenicity was assessed to evaluate the persistence in terms of percentages of subjects with hSBA titers = 1:5, previously received three doses of rMenB+OMV NZ directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.	One month post vaccination and pe-booster (fourth) dose vaccination	No
Secondary	Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)	The immunogenicity was assessed to demonstrate the induction of immunological memory in subjects who were previously received three doses of rMenB+OMV NZ as measured by SBA GMT response in comparison to the fourth dose of rMenB+OMV NZ at 12 months of age ( 12B12M(1a) group) to the response in subjects (12M12B14B 0 who received a single dose of rMenB+OMV NZ vaccine.	one month after booster (fourth) dose vaccination and pre-fourth dose vaccination	No
Secondary	SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule	The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed by SBA GMTs one month after the second dose.	One month after the second dose.	No
Secondary	Percentages of Subjects With SBA Titers =1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule	The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed as percentages of subjects with SBA titers =1:5 one month after the second dose.	One month after the second dose.	No
Secondary	ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months	The immune response against vaccine antigen 287-953 was measured by ELISA, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).	One month after the fourth (booster) dose.	No
Secondary	ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers	The immune response against vaccine antigen 287-953was measured by ELISA one month after the first dose and one month after the second dose of a two-dose catch-up regimens (12M13B15B and 12M12B14B) in toddlers.	One month after the first dose and one month after the second dose.	No
Secondary	Percentages of Subjects With Bactericidal Titers = 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months	The immune response was measured as percentages of subjects with SBA = 1:5 (95% CI) against strain M10713, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).	One month after the fourth (booster) dose.	No
Secondary	Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age	Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered at 12 months. For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M and Groups 12B13M (1b) and 12B13M (3b) are combined as Group 12B13M.	From day 1 to day 7 after each rMenB+OMV NZ vaccination.	No
Secondary	Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination	Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered with a two-dose catch-up schedules (groups 12M13B15B and 12M12B14B).	From day 1 to day 7 after each rMenB+MV NZ vaccination.	No
Secondary	Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age	Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.	From day 1 to day 7 after MMRV vaccination.	No
Secondary	Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age	Safety was assessed as the number of subjects who reported solicited systemic reactions from day 8 through day 28 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.	From day 8 to day 28 after MMRV vaccination.	No