Meningococcal DiseasePhase 2NCT01992536
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
A Phase 2 study testing MenABCWY+OMV and MenABCWY+¼OMV in people with Meningococcal Disease, run by Novartis Vaccines at 13 sites in 2 countries.
Trial summary
The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180) (Groups I and II). Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease
- What is being tested?
- MenABCWY+OMV and MenABCWY+¼OMV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Dec 2013to Apr 2015
- 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 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102_03 (NCT01272180);
- Individuals or the individual's parents or legal guardian who have given written consent after the nature of the study has been explained according to local regulatory requirements;
- Individuals who have given written assent as required by local regulations after the nature of the study has been explained to them according to local regulatory requirements;
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
- Individuals and/or or the individual's parents or legal guardian who can comply with study procedures and are available for follow-up.
Who cannot join
- History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102_03 (NCT01272180);
- Current or previous, confirmed or suspected disease caused by N. meningitidis;
- Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
- All sexually active females that have not used an "acceptable contraceptive method(s)" for at least 2 months prior to study entry. Acceptable birth control methods are defined as one or more of the following:
- Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
Show all 21Show fewer
- Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
- Intrauterine device (IUD)
- Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry;
- Sexually active females that refuse to use to an "acceptable contraceptive method" through to 3 weeks following the study vaccination;
- Female subjects with a positive pregnancy test prior to the study vaccine being administered;
- Nursing (breastfeeding) mothers;
- Individuals with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study;
- Any serious, chronic, or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition);
- Subjects who required chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥ 20mg/day. Inhaled and topical steroids are allowed).
- Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
- Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
- Administration or planned administration, of any vaccine not foreseen by the study protocol within 30 days prior study vaccination, and up to 30 days after the vaccination (with the exception of any licensed influenza vaccine which may be administered >14 days preceding or >14 days following the study vaccination);
- Individuals who study personnel or immediate family members of study personnel including brother, sister, child, parent, or the spouse.
- Individuals who have experienced moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrolment.
- Who have received systemic antibiotic treatment within 7 days prior to enrollment.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States8 sites
Site 28, Kentucky Pediatric/Adult Research 201 South 5th Street
Bardstown, Kentucky, 40004
Site 23, Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
Birmingham, Alabama, 35205
Site 26, Ohio Pediatric Research Association 7200 Poe Ave, Suite 200
Dayton, Ohio, 45414
Site 27, Ohio Pediatric Research Association 1775 Delco Park Drive
Kettering, Ohio, 45420
Site 22, Focus Research Group 201 Signature Place
Lebanon, Tennessee, 37087
Site 21, Bluegrass Clinical Research Inc. 5512 Bardstown Road, Suite 2
Louisville, Kentucky, 40291
Site 24, Madera Family Medical Group 1111 West 4th Street
Madera, California, 93637
Site 25, Center for Clinical Trials LLC 16660 Paramount Blvd, Suite 301
Paramount, California, 90723
Poland5 sites
Site 13, Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska
Ul. Braci Kiemliczów 14, Kraków, 31-223
Site 14, Klinika Pediatrii Centrum Medycznego Kształcenia Podyplomowego,Szpital Bielański
Ul. Cegłowska 80, Warszawa, 01-809
Site 15, Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna, Juniperus" s.c.
ul.Kościuszki 41, Izabelin, 05-080
Site 11, Katedra i Klinika Pediatrii i Chorób Infekcyjnych
ul.O.Bujwida 44, Wrocław, 50-354
Site 12, NZOZ PRAKTIMED Sp.zo.o
ul.Strzelców 15, Kraków, 31-422
About this study
The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the primary vaccination and 12 months after the booster dose will also be evaluated in these subjects.
In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV). These subjects will be followed for safety and immunogenicity for 12 months after vaccination in study V102_03E1.
- Conditions
- Meningococcal Disease
- Being tested
- MenABCWY+OMV, MenABCWY+¼OMV, Placebo
- Keywords
- Meningococcal, Booster, MenABCWY, Menveo, Vaccine Adolescents, Immune Response, N. Meningitidis
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenABCWY+OMVBiological
Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine
MenABCWY+¼OMVBiological
Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine
PlaceboBiological
Saline solution for injection (0.5mL)
| Study group | Role | What they receive |
|---|---|---|
| Ia: MenABCWY+OMV | Experimental | Investigational Receives: Biological: MenABCWY+OMV |
| Ib: Placebo | Placebo comparator | Saline Receives: Biological: Placebo |
| IIa: MenABCWY+¼OMV | Experimental | Investigational Receives: Biological: MenABCWY+¼OMV |
| IIb: Placebo | Placebo comparator | Saline Receives: Biological: Placebo |
| IIIa: MenABCWY+OMV | Experimental | Investigational Receives: Biological: MenABCWY+OMV |
| IIIb: MenABCWY+¼OMV | Experimental | Investigational Receives: Biological: MenABCWY+¼OMV |
| IVa: MenABCWY+OMV | Experimental | Investigational Receives: Biological: MenABCWY+OMV |
| IVb: MenABCWY+¼OMV | Experimental | Investigational Receives: Biological: MenABCWY+¼OMV |
| IVc: Placebo | Placebo comparator | Saline Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.
Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Measured: Day 30
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180).
Measured: Day 1 and Day 30
Secondary outcomes (24)
3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.
Percentage of subjects with HT-hSBA titer ≥ 1:8 in serogroups A, C, W, Y against N. meningitides assessed prior to the administration of MenABCWY booster vaccination or placebo.
Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).
Measured: Day 1 (Pre vaccination)
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B assessed prior to the administration of MenABCWY booster vaccination or placebo.
Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).
Measured: Day 1 (Pre vaccination)
5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.
The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y prior the administration of MenABCWY booster vaccination or placebo.
Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).
Measured: Day 1 (Pre-vaccination)
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
The HT-hSBA GMTs against N. meningitidis strains of serogroup B prior the administration of MenABCWY booster vaccination or placebo.
Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).
Measured: Day 1 (Pre-vaccination)
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.
Measured: Day 1 and Day 30
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
The HT-hSBA GMTs against N. meningitidis strains of serogroups B at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.
Measured: Day 1 and Day 30
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, from Day 1 (baseline) to Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.
Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase.
Measured: Day 1 and Day 30
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.
Measured: Day 1 and Day 30
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.
Measured: Day 1 and Day 30
12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.
Percentage of subjects with seroresponse to N. meningitidis serogroup A, C, W and Y, at Day 30 after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.
Measured: Day 30
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y, at 24 and 36 months after the primary vaccination.
Measured: Day 1 and Day 365
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B, at 24 and 36 months after the primary vaccination.
Measured: Day 1, Day 30 and Day 365
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, at 24 and 36 months after the primary vaccination.
Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase.
Measured: Day 1, Day 30 and Day 365
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y, at 24 and 36 months after the primary vaccination.
Measured: Day 1 and Day 365
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
The HT-hSBA GMTs against N. meningitidis strains of serogroups B, at 24 and 36 months after the primary vaccination.
Measured: Day 1 and Day 365
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Measured: Day 1, Day 30 and Day 365
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitides strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Measured: Day 1, Day 30 and Day 365
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
The HT-hSBA GMTs against Neisseria meningitidis serogroup A, C, W, Y and strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Measured: Day 1, Day 30 and Day 365
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
The HT-hSBA GMTs against Neisseria meningitidis strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Measured: Day 1, Day 30 and Day 365
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination in this study.
Measured: Day 1, Day 30 and Day 365
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Number of subjects reporting solicited local and systemic adverse events after receiving a booster dose of MenABCWY vaccine or placebo. the below reported events are Erythema- Injection site erythema, Induration- Injection site induration, Pain-injection site pain, Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea, Rash, Fever, Prevention- Prevention of Pain and/or Fever, Treatment- Treatment of Pain and/or Fever and Analgesic/Antipyr.: use of Analgesic/Antipyretics in pain and fever.
Measured: From day 1 (6 hours) through day 7 after any vaccination
24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.
Number of subjects reporting unsolicited AEs (any AEs and at least possibly related AEs) after receiving a booster dose of MenABCWY vaccine or placebo from Day 1 to Day 30.
Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.
Measured: Day 1 through Day 30
25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
Number of subjects reporting any serious unsolicited AEs (SAEs), possibly related SAEs, medically attended AEs, unsolicited AEs leading to withdrawal and deaths after receiving a booster dose of MenABCWY vaccine or placebo, are reported for the entire study period.
Measured: Day 1 to Day 365
26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.
Number of subjects reporting New Onset Chronic Disease (NOCD),from the end of the primary parental study V102_03 (NCT01272180) up to Day 1 visit in V102_03E1 study, is reported. (Any NOCD AEs: NOCD V102_03 (NCT01272180) vs. NOCD- Day 1, V102_03E1)
Measured: From primary parent study completion up to Day 1 in this study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionApr 2015
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 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
- NCT01992536
- Sponsor's protocol ID
- V102_03E1
- Other IDs
- 2012-003937-41
- Status last verified
- Aug 2016
- First submitted
- 15 Nov 2013
- Last updated
- 25 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
- ClinicalTrials.gov ID
- NCT01992536
- Acronym / sponsor ID
- V102_03E1
- Conditions
- Meningococcal Disease
- Keywords
- Meningococcal, Booster, MenABCWY, Menveo, Vaccine Adolescents, Immune Response, N. Meningitidis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 25 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the primary vaccination and 12 months after the booster dose will also be evaluated in these subjects.
In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV). These subjects will be followed for safety and immunogenicity for 12 months after vaccination in study V102_03E1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Ia: MenABCWY+OMV | Experimental | Biological: MenABCWY+OMVInvestigational |
| Ib: Placebo | Placebo comparator | Biological: PlaceboSaline |
| IIa: MenABCWY+¼OMV | Experimental | Biological: MenABCWY+¼OMVInvestigational |
| IIb: Placebo | Placebo comparator | Biological: PlaceboSaline |
| IIIa: MenABCWY+OMV | Experimental | Biological: MenABCWY+OMVInvestigational |
| IIIb: MenABCWY+¼OMV | Experimental | Biological: MenABCWY+¼OMVInvestigational |
| IVa: MenABCWY+OMV | Experimental | Biological: MenABCWY+OMVInvestigational |
| IVb: MenABCWY+¼OMV | Experimental | Biological: MenABCWY+¼OMVInvestigational |
| IVc: Placebo | Placebo comparator | Biological: PlaceboSaline |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102_03 (NCT01272180);
- Individuals or the individual's parents or legal guardian who have given written consent after the nature of the study has been explained according to local regulatory requirements;
- Individuals who have given written assent as required by local regulations after the nature of the study has been explained to them according to local regulatory requirements;
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
- Individuals and/or or the individual's parents or legal guardian who can comply with study procedures and are available for follow-up.
Key exclusion criteria (21 listed)
- History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102_03 (NCT01272180);
- Current or previous, confirmed or suspected disease caused by N. meningitidis;
- Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
- All sexually active females that have not used an "acceptable contraceptive method(s)" for at least 2 months prior to study entry. Acceptable birth control methods are defined as one or more of the following:
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 |
|---|---|---|
| MenABCWY+OMVVaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine | Biological | IIIa: MenABCWY+OMV, IVa: MenABCWY+OMV, Ia: MenABCWY+OMV |
| MenABCWY+¼OMVVaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine | Biological | IIIb: MenABCWY+¼OMV, IIa: MenABCWY+¼OMV, IVb: MenABCWY+¼OMV |
| PlaceboSaline solution for injection (0.5mL) | Biological | IIb: Placebo, IVc: Placebo, Ib: Placebo |
Primary outcome
1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.
Time frame: Day 30
Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
Time frame: Day 1 and Day 30
Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180).
24 secondary outcomes
3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.
Time frame: Day 1 (Pre vaccination)
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Time frame: Day 1 (Pre vaccination)
5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.
Time frame: Day 1 (Pre-vaccination)
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
Time frame: Day 1 (Pre-vaccination)
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Time frame: Day 1 and Day 30
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
Time frame: Day 1 and Day 30
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
Time frame: Day 1 and Day 30
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Time frame: Day 1 and Day 30
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
Time frame: Day 1 and Day 30
12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.
Time frame: Day 30
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Time frame: Day 1 and Day 365
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
Time frame: Day 1, Day 30 and Day 365
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
Time frame: Day 1, Day 30 and Day 365
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Time frame: Day 1 and Day 365
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
Time frame: Day 1 and Day 365
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Time frame: Day 1, Day 30 and Day 365
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Time frame: Day 1, Day 30 and Day 365
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Time frame: Day 1, Day 30 and Day 365
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
Time frame: Day 1, Day 30 and Day 365
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Time frame: Day 1, Day 30 and Day 365
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Time frame: From day 1 (6 hours) through day 7 after any vaccination
24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.
Time frame: Day 1 through Day 30
25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
Time frame: Day 1 to Day 365
26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.
Time frame: From primary parent study completion up to Day 1 in this study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MenABCWY+OMV and MenABCWY+¼OMV in people with Meningococcal Disease, run by Novartis Vaccines at 13 sites in 2 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 5 inclusion and 21 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 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Poland. 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. Some participants in this study may receive a placebo. 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 25 Oct 2016). 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?
1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y. (time frame: Day 30). 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?
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 25 Oct 2016.