Meningococcal DiseasePhase 3NCT00847145
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 study testing 1a - rMenB+OMV NZ and routine vaccines, 1b - rMenB+OMV NZ and routine vaccines and 2a - Routine and rMenB+OMV NZ vaccines in people with Meningococcal Disease, run by Novartis Vaccines at 59 sites in 5 countries.
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 Read more about this study
- Who is it for?
- Ages 365 to 394 daysHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease
- What is being tested?
- 1a - rMenB+OMV NZ and routine vaccines, 1b - rMenB+OMV NZ and routine vaccines and 2a - Routine and rMenB+OMV NZ vaccines
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,249 participants
- Where
- 59 sitesin 5 countries
- Study dates
- Feb 2009to Aug 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 365 to 394 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13
Who cannot join
- 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.
Trial locations and contacts
59 sites in 5 countries.
59 sites in 5 countries
Czechia16 sites
Site 27
Boskovice, 680 01
Site 19
Brno, 628 00
Site 22
Chomutov, 430 03
Site 12
Havlíčkův Brod, 580 22
Fakulta vojenskeho zdravotnictví
Hradec Králové, 500 01
Site 28
Hranice I-mesto, 753 01
Site 13
Humpolec, 396 01
Site 25
Kladno, 272 00
Site 21
Kolín, 280 02
Site 10
Liberec, 460 15
Site 24
Litoměřice, 412 01
Site 17
Ostrava, 702 00
Site 18
Ostrava-Poruba, 708 68
Site 16
Pilsen, 305 99
Site 26
Rumburk, 408 01
Site 23
Ústí nad Labem, 400 01
Finland15 sites
Site 30
Espoo, 02100
Site 31
Helsinki, 00100
Site 32
Helsinki, 00930
Site 34
Jarvenpaa, 04400
Site 35
Kokkola, 67100
Site 45
Kotka, 48600
Site 46
Kuopio, 70100
Site 47
Lahti, 15140
Site 49
Oulu, 90220
Site 50
Pori, 28100
Site 51
Seinäjoki, 60100
Site 52
Tampere, 33100
Site 53
Turku, 20520
Site 33
Vantaa, 01300
Site 48
Vantaa, 01600
Germany14 sites
Site 99
Detmold, 32756
Site 92
Espelkamp, 32339
Site 95
Freising, 85354
Site 64
Fulda, 36037
Site 58
Lauffen am Neckar, 74348
Site 57
Marbach A. N., 71672
Site 80
München, 80337
Site 83
München, 81241
Site 97
München, 81377
Site 96
München, 81475
Site 91
Műnchen, 81737
Site 81
Porta Westfalica, 32457
Site 65
Schwieberdingen, 71701
Site 94
Weilheim, 82362
Austria7 sites
Altenburger
Eisenstadt, 7000
Grässl
Hall in Tirol, 6060
Häckel
Kirchdorf, 4560
Prieler
Neufeld A.d. Leitha, 2491
Maurer
Salzburg, 5020
Sommer
Vienna, 1230
Angermayr
Wels, 4600
Italy7 sites
Dipartimento di Scienze della Salute
Genova, Genova, 16132
Universita degli Studi di Messina, Policlinico G. Martino
Messina
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
Milan, Milano, 20122
Pediatria dell' Ospedale Sacco
Milan, Milano, 20157
Ospedale Maggiore di Novara
Novara, 28100
Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
Sassari, Sassari, 07100
ASL/TA
Taranto, Taranto, 74100
About this study
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
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
- Conditions
- Meningococcal Disease
- Being tested
- 1a - rMenB+OMV NZ and routine vaccines, 1b - rMenB+OMV NZ and routine vaccines, 2a - Routine and rMenB+OMV NZ vaccines, 2b - rMenB+OMV NZ and routine vaccines, 3a - rMenB+OMV NZ and routine vaccines
- Keywords
- toddler, Meningococcal disease, prevention, vaccination
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1a - rMenB+OMV NZ and routine vaccinesBiological
One dose of rMenB vaccine and routine vaccine at study month 12.
1b - rMenB+OMV NZ and routine vaccinesBiological
One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.
2a - Routine and rMenB+OMV NZ vaccinesBiological
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 vaccinesBiological
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 vaccinesBiological
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 vaccinationsBiological
One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.
4a- rMenB+OMV NZ and routine vaccinesBiological
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
4b - rMenB+OMV NZ and routine vaccinesBiological
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
| Study group | Role | What they receive |
|---|---|---|
| 12B12M (1a) | Experimental | Previously 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. Receives: Biological: 1a - rMenB+OMV NZ and routine vaccines |
| 12B13M (1b) | Experimental | Previously 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. Receives: Biological: 1b - rMenB+OMV NZ and routine vaccines |
| 12M13B15B (2a) | Experimental | Previously 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. Receives: Biological: 2a - Routine and rMenB+OMV NZ vaccines |
| 12M12B14B (2b) | Experimental | Previously 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. Receives: Biological: 2b - rMenB+OMV NZ and routine vaccines |
| 12B12M (3a) | Experimental | Previously 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. Receives: Biological: 3a - rMenB+OMV NZ and routine vaccines |
| 12B13M (3b) | Experimental | Previously 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. Receives: Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations |
| 12B12M_C (4a) | Experimental | Previously 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. Receives: Biological: 4a- rMenB+OMV NZ and routine vaccines |
| 12B13M_C (4b) | Experimental | Previously 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. Receives: Biological: 4b - rMenB+OMV NZ and routine vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month after the booster (fourth) dose
Secondary outcomes (14)
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.
Measured: one month after booster (fourth) dose
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: one month after booster (fourth) dose vaccination and pre-fourth dose vaccination
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.
Measured: One month after the second dose.
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.
Measured: One month after the second dose.
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).
Measured: One month after the fourth (booster) dose.
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.
Measured: One month after the first dose and one month after the second dose.
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).
Measured: One month after the fourth (booster) dose.
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.
Measured: From day 1 to day 7 after each rMenB+OMV NZ vaccination.
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).
Measured: From day 1 to day 7 after each rMenB+MV NZ vaccination.
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.
Measured: From day 1 to day 7 after MMRV vaccination.
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.
Measured: From day 8 to day 28 after MMRV vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847145
- Sponsor's protocol ID
- V72P13E1
- Other IDs
- 2008-006301-17, 2008
- Status last verified
- Mar 2015
- First submitted
- 18 Feb 2009
- Last updated
- 3 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 31110098Vesikari 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.
PubMed 23324563
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00847145
- Acronym / sponsor ID
- V72P13E1
- Conditions
- Meningococcal Disease
- Keywords
- toddler, Meningococcal disease, prevention, vaccination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,249 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Posted 3 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 12B12M (1a) | Experimental | Biological: 1a - rMenB+OMV NZ and routine vaccinesPreviously 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) | Experimental | Biological: 1b - rMenB+OMV NZ and routine vaccinesPreviously 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) | Experimental | Biological: 2a - Routine and rMenB+OMV NZ vaccinesPreviously 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) | Experimental | Biological: 2b - rMenB+OMV NZ and routine vaccinesPreviously 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) | Experimental | Biological: 3a - rMenB+OMV NZ and routine vaccinesPreviously 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) | Experimental | Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinationsPreviously 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) | Experimental | Biological: 4a- rMenB+OMV NZ and routine vaccinesPreviously 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) | Experimental | Biological: 4b - rMenB+OMV NZ and routine vaccinesPreviously 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. |
Who may qualify
- Ages
- 365 to 394 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1a - rMenB+OMV NZ and routine vaccinesOne dose of rMenB vaccine and routine vaccine at study month 12. | Biological | 12B12M (1a) |
| 1b - rMenB+OMV NZ and routine vaccinesOne dose of rMenB vaccine at study month 12 and routine vaccine at study month 13. | Biological | 12B13M (1b) |
| 2a - Routine and rMenB+OMV NZ vaccinesOne dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15. | Biological | 12M13B15B (2a) |
| 2b - rMenB+OMV NZ and routine vaccinesTwo doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12. | Biological | 12M12B14B (2b) |
| 3a - rMenB+OMV NZ and routine vaccinesOne dose of rMenB vaccine and one dose of routine vaccine at study month 12. | Biological | 12B12M (3a) |
| 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinationsOne dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13. | Biological | 12B13M (3b) |
| 4a- rMenB+OMV NZ and routine vaccinesOne dose of rMenB vaccine and one dose of routine vaccine at study month 12. | Biological | 12B12M_C (4a) |
| 4b - rMenB+OMV NZ and routine vaccinesOne dose of rMenB vaccine and one dose of routine vaccine at study month 12. | Biological | 12B13M_C (4b) |
Primary outcome
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
Time frame: one month after the booster (fourth) dose
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.
14 secondary outcomes
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
Time frame: one month after booster (fourth) dose
The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: one month after booster (fourth) dose vaccination and pre-fourth dose vaccination
SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule
Time frame: One month after the second dose.
Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule
Time frame: One month after the second dose.
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months
Time frame: One month after the fourth (booster) dose.
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers
Time frame: One month after the first dose and one month after the second dose.
Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months
Time frame: One month after the fourth (booster) dose.
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Time frame: From day 1 to day 7 after each rMenB+OMV NZ vaccination.
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Time frame: From day 1 to day 7 after each rMenB+MV NZ vaccination.
Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age
Time frame: From day 1 to day 7 after MMRV vaccination.
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Time frame: From day 8 to day 28 after MMRV vaccination.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31110098Zafack 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.
- Derived from this study: PubMed 23324563Vesikari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Vaccines study chair
Novartis Vaccines
59 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1a - rMenB+OMV NZ and routine vaccines, 1b - rMenB+OMV NZ and routine vaccines and 2a - Routine and rMenB+OMV NZ vaccines in people with Meningococcal Disease, run by Novartis Vaccines at 59 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Czechia, Finland, Germany, Austria, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination (time frame: one month after the booster (fourth) dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00847145, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.