Meningococcal DiseasePhase 2NCT00433914

Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants

A Phase 2 study testing rMenB and rMenB+OMV in people with Meningococcal Disease, run by Novartis Vaccines at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants. Read more about this study

Who is it for?: Ages 6 to 8 monthsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease
What is being tested?: rMenB and rMenB+OMV
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited Kingdom
Study dates: Feb 2007to Jul 2008
Phase: Phase 2
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 6 to 8 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

healthy 6-8 months old infants

Who cannot join

previous receipt of any meningococcal B vaccine;
previous ascertained or suspected disease caused by N meningitidis;
history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
any present or suspected serious acute or chronic disease
known or suspected autoimmune disease or impairment /alteration of immune function

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Study site
Oxford, OX3 7LJ

Other trials in United Kingdom

About this study

Official title: A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, When Administered to Healthy Infants 6-8 Months Old

To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.

Conditions: Meningococcal Disease
Being tested: rMenB, rMenB+OMV
Keywords: 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.

rMenBBiological
Also called Serogroup B meningococcal recombinant vaccine without OMV-NZ
One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
rMenB+OMVBiological
Also called Serogroup B meningococcal recombinant vaccine with OMV-NZ
One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.

Study groups in NCT00433914
Study group	Role	What they receive
rMenB	Experimental	6-8 months-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and 12 months of age. Receives: Biological: rMenB
rMenB+OMV	Experimental	6-8 months-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and 12 months of age. Receives: Biological: rMenB+OMV

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).
Measured: Baseline and one month after second and third vaccination
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Measured: Baseline and one month after second and third vaccination

Secondary outcomes (5)

Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Measured: One month after second and third vaccination
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Measured: Baseline and one month after second and third vaccination
Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Measured: Baseline and one month after second and third vaccination
Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Measured: One month after second and third vaccination
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3).
Measured: Day 1 through day 7 after each vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Jul 2008

First posted12 Feb 2007 (estimated)
Study startFeb 2007
Primary completionDec 2007
Study completionJul 2008

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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00433914
Sponsor's protocol ID: V72P9
Other IDs: Eudract Number: 2006-005589-38
Status last verified: Mar 2015
First submitted: 9 Feb 2007
Last updated: 6 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.
PubMed 35257644
Snape MD, Dawson T, Oster P, Evans A, John TM, Ohene-Kena B, Findlow J, Yu LM, Borrow R, Ypma E, Toneatto D, Pollard AJ. Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J. 2010 Nov;29(11):e71-9. doi: 10.1097/INF.0b013e3181f59f6d.
PubMed 20844462

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Meningococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, When Administered to Healthy Infants 6-8 Months Old
ClinicalTrials.gov ID: NCT00433914
Acronym / sponsor ID: V72P9
Conditions: Meningococcal Disease
Keywords: Meningococcal disease, prevention, vaccination
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Dec 2007 (actual)
Study completion: Jul 2008 (actual)
First posted: 12 Feb 2007 (estimated)
Results: Posted 6 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
rMenB	Experimental	Biological: rMenB6-8 months-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and 12 months of age.
rMenB+OMV	Experimental	Biological: rMenB+OMV6-8 months-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and 12 months of age.

Who may qualify

Ages: 6 to 8 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

healthy 6-8 months old infants

Key exclusion criteria (5 listed)

previous receipt of any meningococcal B vaccine;
previous ascertained or suspected disease caused by N meningitidis;
history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
any present or suspected serious acute or chronic disease
known or suspected autoimmune disease or impairment /alteration of immune function

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
rMenBAlso: Serogroup B meningococcal recombinant vaccine without OMV-NZOne dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.	Biological	rMenB
rMenB+OMVAlso: Serogroup B meningococcal recombinant vaccine with OMV-NZOne dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.	Biological	rMenB+OMV

Primary outcome

Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Time frame: Baseline and one month after second and third vaccination
Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Time frame: Baseline and one month after second and third vaccination
Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).

5 secondary outcomes

Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Time frame: One month after second and third vaccination
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Time frame: Baseline and one month after second and third vaccination
Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Time frame: Baseline and one month after second and third vaccination
Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Time frame: One month after second and third vaccination
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ
Time frame: Day 1 through day 7 after each vaccination

Results and safety

Results posted to the registry on 6 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rMenB	30	30
rMenB+OMV	30	27

Primary outcome: Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Time frame: Baseline and one month after second and third vaccination. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	rMenB n = 25	rMenB+OMV n = 24
Strain 44/76-SL - Baseline	8 (1 to 26)	29 (13 to 51)
Strain 44/76-SL - Post-2nd Vaccination (N=25,23)	100 (86 to 100)	100 (85 to 100)
Strain 44/76-SL - Post-3rd Vaccination (N=24,24)	100 (86 to 100)	100 (86 to 100)
Strain 5/99 - Baseline	0 (0 to 14)	0 (0 to 14)
Strain 5/99 - Post-2nd Vaccination (N=25,23)	100 (86 to 100)	100 (85 to 100)
Strain 5/99 - Post-3rd Vaccination (N=24,24)	100 (86 to 100)	100 (86 to 100)
Strain NZ98/254 - Baseline	0 (0 to 14)	0 (0 to 14)
Strain NZ98/254 - Post-2nd Vaccination (N=24,22)	4 (0 to 21)	95 (77 to 100)

Population analysed: Analysis was performed on the per protocol (PP) population set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to analysis.

Primary outcome: Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Time frame: Baseline and one month after second and third vaccination. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	rMenB n = 25	rMenB+OMV n = 24
Strain 44/76-SL - Baseline	0 (0 to 14)	4 (0 to 21)
Strain 44/76-SL - Post-2nd Vaccination (N=25,23)	96 (80 to 100)	100 (85 to 100)
Strain 44/76-SL - Post-3rd Vaccination (N=24,24)	100 (86 to 100)	100 (86 to 100)
Strain 5/99 - Baseline	0 (0 to 14)	0 (0 to 14)
Strain 5/99 - Post-2nd Vaccination (N=25,23)	100 (86 to 100)	100 (85 to 100)
Strain 5/99 - Post-3rd Vaccination (N=24,24)	100 (86 to 100)	100 (86 to 100)
Strain NZ98/254 - Baseline	0 (0 to 14)	0 (0 to 14)
Strain NZ98/254 - Post-2nd Vaccination (N=24,22)	0 (0 to 14)	91 (71 to 99)

Population analysed: Analysis was performed on the per protocol (PP) population set.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rMenB	5 of 30 (16.7%)	30 of 30 (100%)	Not reported
rMenB+OMV	1 of 30 (3.3%)	30 of 30 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35257644Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.
Derived from this study: PubMed 20844462Snape MD, Dawson T, Oster P, Evans A, John TM, Ohene-Kena B, Findlow J, Yu LM, Borrow R, Ypma E, Toneatto D, Pollard AJ. Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J. 2010 Nov;29(11):e71-9. doi: 10.1097/INF.0b013e3181f59f6d.

Related trials for Meningococcal Disease

Not yet recruitingPhase 4
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RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
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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 (formerly Chiron Vaccines) Novartis study chair

Novartis Vaccines

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rMenB and rMenB+OMV in people with Meningococcal Disease, run by Novartis Vaccines at 1 site in United Kingdom.

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 6 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 1 site in United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 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?

Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ (time frame: Baseline and one month after second and third vaccination). The study lists 2 primary outcomes in all. 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 NCT00433914, 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 6 Mar 2015.