Overview

This trial is active, not recruiting.

Condition meningococcal disease
Treatments menabcwy+omv, menabcwy+¼omv, placebo
Phase phase 2
Sponsor Novartis Vaccines
Start date December 2013
End date May 2015
Trial size 194 participants
Trial identifier NCT01992536, 2012-003937-41, V102_03E1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Investigational
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)
Saline
placebo
Saline solution for injection (0.5mL)
(Experimental)
Investigational
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)
Saline
placebo
Saline solution for injection (0.5mL)
(Experimental)
Investigational
menabcwy+omv
Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine
(Experimental)
Investigational
menabcwy+¼omv
Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine
(Experimental)
Investigational
menabcwy+omv
Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine
(Experimental)
Investigational
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)
Saline
placebo
Saline solution for injection (0.5mL)

Primary Outcomes

Measure
Percentage of subjects with seroresponse to N. meningitidis serogroups A, C, W and Y
time frame: 30 days following administration of a MenABCWY vaccination or placebo
Percentage of subjects with hSBA titer >=1:5 to N. meningitidis serogroups B strains
time frame: 30 days following administration of a MenABCWY vaccination or placebo

Secondary Outcomes

Measure
Percentage of subjects with hSBA titer >=1:8 to N. meningitidis serogroups A, C, W and Y
time frame: Prior to Vaccination
Percentage of subjects with hSBA titer >=1:5 s to N. meningitidis serogroups B strains
time frame: Prior to Vaccination
hSBA GMTs against N. meningitidis serogroups A, C, W and Y and strains of serogroup B
time frame: Prior to Vaccination
Percentage of subjects with hSBA titer >=1:8 and GMTs to N. meningitidis serogroups A, C, W and Y
time frame: 30 days following administration of a MenABCWY vaccination or placebo
Percentage of subjects with four-fold rise and GMTs to N. meningitidis serogroups B strains
time frame: 30 days following administration of a MenABCWY vaccination or placebo
hSBA GMTs against N. meningitidis serogroups A, C, W and Y and strains of serogroup B
time frame: 30 days following administration of a MenABCWY vaccination or placebo
Percentage of subjects with seroresponse and with hSBA titer >=1:8 against N. meningitidis serogroups A, C, W and Y
time frame: 365 days following administration of a MenABCWY vaccination or placebo
Percentage of subjects with hSBA titer >=1:5, and with four-fold rise against N.meningitidis serogroups B strains
time frame: 365 days following administration of a MenABCWY vaccination or placebo
hSBA GMTs
time frame: 365 days following administration of a MenABCWY vaccination or placebo

Eligibility Criteria

Male or female participants from 10 years up to 25 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Novartis.