Overview

This trial is active, not recruiting.

Condition meningococcal disease
Treatments rmenb+omv, placebo, hep a, abcwy
Phase phase 2
Sponsor Novartis
Start date August 2014
End date February 2016
Trial size 1050 participants
Trial identifier NCT02212457, V102_15

Summary

The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give the flexibility for the national vaccination program by showing the safety and immunogenicity of MenABCWY administrated according to four different vaccination schedules and additionally to evaluate a potential benefit of the 3-dose vaccination series.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Experimental)
approximately 150 subjects receiving MenABCWY vaccine at Visit Month 0 and Visit Month 1, Hepatitis A vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6
placebo
hep a
abcwy
(Experimental)
approximately 150 subjects receiving MenABCWY vaccine at Visit Month 0 and Visit Month 6, Hepatitis A vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2
placebo
hep a
abcwy
(Experimental)
approximately 150 subjects receiving MenABCWY vaccine at Visit Month 1 and Visit Month 12, Hepatitis A vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2
placebo
hep a
abcwy
(Experimental)
approximately 150 subjects receiving MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6, Hepatitis A vaccine at Visit Month 1 and 12.
hep a
abcwy
(Experimental)
approximately 225 subjects receiving MenABCWY vaccine at Visit Month 0 and Visit Month 2, Hepatitis A vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1
placebo
hep a
abcwy
(Experimental)
approximately 225 subjects receiving rMenB+OMV vaccine at Visit Month 0 and Visit Month 2, Hepatitis A vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1
rmenb+omv
placebo
hep a

Primary Outcomes

Measure
hSBA GMTs against each of N. meningitidis serogroup B test strains (B_0_2 and ABCWY_0_2 groups only)
time frame: 1 month after the last meningococcal vaccination

Secondary Outcomes

Measure
hSBA GMTs against each of N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
time frame: 1 month after the last meningococcal vaccination
Percentage of subjects with hSBA titers ≥ LLQ, ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against each of N. meningitidis serogroups A, C, W and Y and serogroup B test strains
time frame: Month 0 (baseline), Month 2, Month 3, Month 7, and Month 13
Percentage of subjects with hSBA titers ≥LLQ against all four N. meningitidis serogroups (A, C, W and Y) and against all four serogroup B test strains.
time frame: Month 0 (baseline), Month 2, Month 3, Month 7, and Month 13
Percentage of subjects with hSBA titers ≥LLQ against N. meningitidis serogroups C and Y, and three serogroup B test strains (fHbp, NadA and NHBA).
time frame: Month 0 (baseline), Month 2, Month 3, Month 7, and Month 13
Percentages of subjects with two-, three-, and four-fold rise in hSBA titers against the N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
time frame: Month 2, Month 3, Month 7, and Month 13 with respect to baseline (Month 0)
AUC (AUC Month 0 - Month 13) for % of subjects with hSBA titers ≥LLQ for all serogroups (A,C,W&Y) & for all serogroup B test strains & for subjects with hSBA≥LLQ for serogroups C and Y, & fHbp, NadA and NHBA test strains only.
time frame: from Month 0 to Month 13
hSBA GMTs against additional serogroup B strains (fHbp and NadA).
time frame: 1 month after the second meningococcal vaccination
Percentages of subjects with hSBA≥1:5 against additional serogroup B strains (fHbp and NadA).
time frame: 1 month after the second meningococcal vaccination
Any AEs reported within 30 minutes after each vaccination
time frame: Entire study period
Solicited local and systemic AEs reported from Day 1 to Day 7 after each and any vaccination
time frame: Entire study period
Other indicators of reactogenicity within 7 days after each and any vaccination
time frame: Entire study period
Unsolicited AEs reported from Day 1 to Day 30 after each and any vaccination
time frame: Entire study period
AEs leading to premature withdrawal from the study
time frame: Entire study period
SAEs reported during the entire study period
time frame: Entire study period

Eligibility Criteria

Male or female participants from 10 years up to 18 years old.

Inclusion Criteria: 1. Adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment. 2. Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts). 3. Female subjects of childbearing potential must have a negative urine preganancy test. Exclusion Criteria: 1. Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines. 2. Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.

Additional Information

Official title A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to Novartis Meningococcal Group B Vaccine, in Healthy Adolescents
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Novartis.