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
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
2 other identifiers
interventional
2,249
5 countries
59
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 of Age or as a Two-dose Catch-up to Healthy Toddlers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2009
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 18, 2009
CompletedFirst Posted
Study publicly available on registry
February 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
March 3, 2015
CompletedMarch 3, 2015
March 1, 2015
1.5 years
February 18, 2009
February 3, 2015
March 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (14)
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
one month after booster (fourth) dose
The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
one month after booster (fourth) vaccination.
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
one month after third vaccination and pre dose fourth (booster) vaccination
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
One month post vaccination and pe-booster (fourth) dose vaccination
Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)
one month after booster (fourth) dose vaccination and pre-fourth dose vaccination
- +9 more secondary outcomes
Study Arms (8)
12B12M (1a)
EXPERIMENTALPreviously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
12B13M (1b)
EXPERIMENTALPreviously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
12M13B15B (2a)
EXPERIMENTALPreviously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
12M12B14B (2b)
EXPERIMENTALPreviously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
12B12M (3a)
EXPERIMENTALPreviously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
12B13M (3b)
EXPERIMENTALPreviously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
12B12M_C (4a)
EXPERIMENTALPreviously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
12B13M_C (4b)
EXPERIMENTALPreviously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
Interventions
One dose of rMenB vaccine and routine vaccine at study month 12.
One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.
One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
Eligibility Criteria
You may qualify if:
- Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
Altenburger
Eisenstadt, 7000, Austria
Grässl
Hall in Tirol, 6060, Austria
Häckel
Kirchdorf, 4560, Austria
Prieler
Neufeld A.d. Leitha, 2491, Austria
Maurer
Salzburg, 5020, Austria
Sommer
Vienna, 1230, Austria
Angermayr
Wels, 4600, Austria
Site 27
Boskovice, 680 01, Czechia
Site 19
Brno, 628 00, Czechia
Site 22
Chomutov, 430 03, Czechia
Site 12
Havlíčkův Brod, 580 22, Czechia
Fakulta vojenskeho zdravotnictví
Hradec Králové, 500 01, Czechia
Site 28
Hranice I-mesto, 753 01, Czechia
Site 13
Humpolec, 396 01, Czechia
Site 25
Kladno, 272 00, Czechia
Site 21
Kolín, 280 02, Czechia
Site 10
Liberec, 460 15, Czechia
Site 24
Litoměřice, 412 01, Czechia
Site 17
Ostrava, 702 00, Czechia
Site 18
Ostrava-Poruba, 708 68, Czechia
Site 16
Pilsen, 305 99, Czechia
Site 26
Rumburk, 408 01, Czechia
Site 23
Ústí nad Labem, 400 01, Czechia
Site 30
Espoo, 02100, Finland
Site 31
Helsinki, 00100, Finland
Site 32
Helsinki, 00930, Finland
Site 34
Jarvenpaa, 04400, Finland
Site 35
Kokkola, 67100, Finland
Site 45
Kotka, 48600, Finland
Site 46
Kuopio, 70100, Finland
Site 47
Lahti, 15140, Finland
Site 49
Oulu, 90220, Finland
Site 50
Pori, 28100, Finland
Site 51
Seinäjoki, 60100, Finland
Site 52
Tampere, 33100, Finland
Site 53
Turku, 20520, Finland
Site 33
Vantaa, 01300, Finland
Site 48
Vantaa, 01600, Finland
Site 99
Detmold, 32756, Germany
Site 92
Espelkamp, 32339, Germany
Site 95
Freising, 85354, Germany
Site 64
Fulda, 36037, Germany
Site 58
Lauffen am Neckar, 74348, Germany
Site 57
Marbach A. N., 71672, Germany
Site 80
München, 80337, Germany
Site 83
München, 81241, Germany
Site 97
München, 81377, Germany
Site 96
München, 81475, Germany
Site 91
Műnchen, 81737, Germany
Site 81
Porta Westfalica, 32457, Germany
Site 65
Schwieberdingen, 71701, Germany
Site 94
Weilheim, 82362, Germany
Dipartimento di Scienze della Salute
Genova, Genova, 16132, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
Milan, Milano, 20122, Italy
Pediatria dell' Ospedale Sacco
Milan, Milano, 20157, Italy
Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
Sassari, Sassari, 07100, Italy
ASL/TA
Taranto, Taranto, 74100, Italy
Universita degli Studi di Messina, Policlinico G. Martino
Messina, Italy
Ospedale Maggiore di Novara
Novara, 28100, Italy
Related Publications (2)
Zafack JG, Bureau A, Skowronski DM, De Serres G. Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials. BMJ Open. 2019 May 19;9(5):e026953. doi: 10.1136/bmjopen-2018-026953.
PMID: 31110098DERIVEDVesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013 Mar 9;381(9869):825-35. doi: 10.1016/S0140-6736(12)61961-8.
PMID: 23324563DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
None reported.
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2009
First Posted
February 19, 2009
Study Start
February 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
March 3, 2015
Results First Posted
March 3, 2015
Record last verified: 2015-03