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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992536
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : October 25, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief 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). 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.


Condition or disease Intervention/treatment Phase
Meningococcal Disease Biological: MenABCWY+OMV Biological: MenABCWY+¼OMV Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)
Study Start Date : December 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : April 2015


Arm Intervention/treatment
Experimental: Ia: MenABCWY+OMV
Investigational
Biological: MenABCWY+OMV
Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine

Placebo Comparator: Ib: Placebo
Saline
Biological: Placebo
Saline solution for injection (0.5mL)

Experimental: IIa: MenABCWY+¼OMV
Investigational
Biological: MenABCWY+¼OMV
Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine

Placebo Comparator: IIb: Placebo
Saline
Biological: Placebo
Saline solution for injection (0.5mL)

Experimental: IIIa: MenABCWY+OMV
Investigational
Biological: MenABCWY+OMV
Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine

Experimental: IIIb: MenABCWY+¼OMV
Investigational
Biological: MenABCWY+¼OMV
Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine

Experimental: IVa: MenABCWY+OMV
Investigational
Biological: MenABCWY+OMV
Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine

Experimental: IVb: MenABCWY+¼OMV
Investigational
Biological: MenABCWY+¼OMV
Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine

Placebo Comparator: IVc: Placebo
Saline
Biological: Placebo
Saline solution for injection (0.5mL)




Primary Outcome Measures :
  1. 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. 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).


Secondary Outcome Measures :
  1. 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. [ Time Frame: Day 1 (Pre vaccination) ]

    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).


  2. 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. [ Time Frame: Day 1 (Pre vaccination) ]

    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).


  3. 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. [ Time Frame: Day 1 (Pre-vaccination) ]

    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).


  4. 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. [ Time Frame: Day 1 (Pre-vaccination) ]

    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).


  5. 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. [ Time Frame: Day 1 and Day 30 ]
    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.

  6. 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. [ Time Frame: Day 1 and Day 30 ]
    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.

  7. 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 ]

    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.


  8. 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 ]
    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.

  9. 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. [ Time Frame: Day 1 and Day 30 ]
    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.

  10. 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 ]
    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.

  11. 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 ]
    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.

  12. 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 ]
    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.

  13. 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 ]

    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.


  14. 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. [ Time Frame: Day 1 and Day 365 ]
    The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y, at 24 and 36 months after the primary vaccination.

  15. 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. [ Time Frame: Day 1 and Day 365 ]
    The HT-hSBA GMTs against N. meningitidis strains of serogroups B, at 24 and 36 months after the primary vaccination.

  16. 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 ]
    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.

  17. 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 ]
    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.

  18. 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 ]
    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.

  19. 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. [ Time Frame: Day 1, Day 30 and Day 365 ]
    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.

  20. 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 ]
    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.

  21. 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 ]
    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.

  22. 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 ]

    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.


  23. 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. [ Time Frame: Day 1 to Day 365 ]
    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.

  24. 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. ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102_03 (NCT01272180);
  2. 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;
  3. 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;
  4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
  5. Individuals and/or or the individual's parents or legal guardian who can comply with study procedures and are available for follow-up.

Exclusion Criteria:

  1. History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102_03 (NCT01272180);
  2. Current or previous, confirmed or suspected disease caused by N. meningitidis;
  3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
  4. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
  5. 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:

    1. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
    2. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
    3. Intrauterine device (IUD)
    4. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry;
  6. Sexually active females that refuse to use to an "acceptable contraceptive method" through to 3 weeks following the study vaccination;
  7. Female subjects with a positive pregnancy test prior to the study vaccine being administered;
  8. Nursing (breastfeeding) mothers;
  9. 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;
  10. 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);
  11. 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).
  12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
  13. 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;
  14. 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);
  15. Individuals who study personnel or immediate family members of study personnel including brother, sister, child, parent, or the spouse.
  16. Individuals who have experienced moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrolment.
  17. Who have received systemic antibiotic treatment within 7 days prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992536


Locations
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United States, Alabama
Site 23, Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
Birmingham, Alabama, United States, 35205
United States, California
Site 24, Madera Family Medical Group 1111 West 4th Street
Madera, California, United States, 93637
Site 25, Center for Clinical Trials LLC 16660 Paramount Blvd, Suite 301
Paramount, California, United States, 90723
United States, Kentucky
Site 28, Kentucky Pediatric/Adult Research 201 South 5th Street
Bardstown, Kentucky, United States, 40004
Site 21, Bluegrass Clinical Research Inc. 5512 Bardstown Road, Suite 2
Louisville, Kentucky, United States, 40291
United States, Ohio
Site 26, Ohio Pediatric Research Association 7200 Poe Ave, Suite 200
Dayton, Ohio, United States, 45414
Site 27, Ohio Pediatric Research Association 1775 Delco Park Drive
Kettering, Ohio, United States, 45420
United States, Tennessee
Site 22, Focus Research Group 201 Signature Place
Lebanon, Tennessee, United States, 37087
Poland
Site 15, Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna, Juniperus" s.c.
ul.Kościuszki 41, Izabelin, Poland, 05-080
Site 13, Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska
ul. Braci Kiemliczów 14, Kraków, Poland, 31-223
Site 12, NZOZ PRAKTIMED Sp.zo.o
ul.Strzelców 15, Kraków, Poland, 31-422
Site 14, Klinika Pediatrii Centrum Medycznego Kształcenia Podyplomowego,Szpital Bielański
ul. Cegłowska 80, Warszawa, Poland, 01-809
Site 11, Katedra i Klinika Pediatrii i Chorób Infekcyjnych
ul.O.Bujwida 44, Wrocław, Poland, 50-354
Sponsors and Collaborators
Novartis Vaccines
Investigators
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Study Chair: Novartis Vaccines Novartis Vaccines
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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01992536    
Other Study ID Numbers: V102_03E1
2012-003937-41 ( EudraCT Number )
First Posted: November 25, 2013    Key Record Dates
Results First Posted: October 25, 2016
Last Update Posted: October 25, 2016
Last Verified: August 2016
Keywords provided by Novartis ( Novartis Vaccines ):
Meningococcal
Booster
MenABCWY
Menveo
Vaccine Adolescents
Immune Response
N. Meningitidis
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections