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

Meningococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992536
• Other study ID #: V102_03E1
• Secondary ID: 2012-003937-41
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2013
• Last updated: May 7, 2015
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPoland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: April 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 25 Years

Eligibility

Inclusion Criteria:

1. Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102_03;

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;

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 Intrauterine device (IUD)

d. 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 enrolment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• MenABCWY+OMV
Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine
• MenABCWY+¼OMV
Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine
• Placebo
Saline solution for injection (0.5mL)

Locations

Country	Name	City	State
Poland	Site 13, Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska	ul. Braci Kiemliczów 14	Kraków
Poland	Site 14, Klinika Pediatrii Centrum Medycznego Ksztalcenia Podyplomowego,Szpital Bielanski	ul. Ceglowska 80	Warszawa
Poland	Site 15, Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna, Juniperus" s.c.	ul.Kosciuszki 41	Izabelin
Poland	Site 11, Katedra i Klinika Pediatrii i Chorób Infekcyjnych	ul.O.Bujwida 44	Wroclaw
Poland	Site 12, NZOZ PRAKTIMED Sp.zo.o	ul.Strzelców 15	Kraków
United States	Site 28, Kentucky Pediatric/Adult Research 201 South 5th Street	Bardstown	Kentucky
United States	Site 23, Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615	Birmingham	Alabama
United States	Site 26, Ohio Pediatric Research Association 7200 Poe Ave, Suite 200	Dayton	Ohio
United States	Site 27, Ohio Pediatric Research Association 1775 Delco Park Drive	Kettering	Ohio
United States	Site 22, Focus Research Group 201 Signature Place	Lebanon	Tennessee
United States	Site 21, Bluegrass Clinical Research Inc. 5512 Bardstown Road, Suite 2	Louisville	Kentucky
United States	Site 24, Madera Family Medical Group 1111 West 4th Street	Madera	California
United States	Site 25, Center for Clinical Trials LLC 16660 Paramount Blvd, Suite 301	Paramount	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with seroresponse to N. meningitidis serogroups A, C, W and Y		30 days following administration of a MenABCWY vaccination or placebo	No
Primary	Percentage of subjects with hSBA titer >=1:5 to N. meningitidis serogroups B strains		30 days following administration of a MenABCWY vaccination or placebo	No
Secondary	Percentage of subjects with hSBA titer >=1:8 to N. meningitidis serogroups A, C, W and Y		Prior to Vaccination	No
Secondary	Percentage of subjects with hSBA titer >=1:5 s to N. meningitidis serogroups B strains		Prior to Vaccination	No
Secondary	hSBA GMTs against N. meningitidis serogroups A, C, W and Y and strains of serogroup B		Prior to Vaccination	No
Secondary	Percentage of subjects with hSBA titer >=1:8 and GMTs to N. meningitidis serogroups A, C, W and Y		30 days following administration of a MenABCWY vaccination or placebo	No
Secondary	Percentage of subjects with four-fold rise and GMTs to N. meningitidis serogroups B strains		30 days following administration of a MenABCWY vaccination or placebo	No
Secondary	hSBA GMTs against N. meningitidis serogroups A, C, W and Y and strains of serogroup B		30 days following administration of a MenABCWY vaccination or placebo	No
Secondary	Percentage of subjects with seroresponse and with hSBA titer >=1:8 against N. meningitidis serogroups A, C, W and Y		365 days following administration of a MenABCWY vaccination or placebo	No
Secondary	Percentage of subjects with hSBA titer >=1:5, and with four-fold rise against N.meningitidis serogroups B strains		365 days following administration of a MenABCWY vaccination or placebo	No
Secondary	hSBA GMTs		365 days following administration of a MenABCWY vaccination or placebo	No