Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents

NCT02140762 | Completed Phase 2 Results

• 1 other identifier: V102_16
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 8

Brief Summary

Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.

Conditions

Meningococcal Disease

Keywords

Meningitis ABCWY; Adolescents; Vaccination; Meningococcal disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.

  The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.

  One month after the second vaccination (month 3)

Secondary Outcomes (27)

• Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.

  Four months after the second vaccination (month 6)

• Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination

  One month after the second vaccination (month 3)

• Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.

  Four months after the second vaccination (month 6)

• Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject

  Baseline, one month after second vaccination (month 3)

• Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject

  Baseline, four months after second vaccination (month 6)

Study Arms (2)

MenABCWY

EXPERIMENTAL

Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months

Biological: MenABCWY

Placebo/MenACWY

ACTIVE COMPARATOR

Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months

Other: Placebo; Biological: MenACWY

Interventions

MenABCWY BIOLOGICAL

Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.

Also known as: MenACWY conjugate combined with rMenB + OMV

MenABCWY

Placebo OTHER

0.5 mL saline solution (IM)

Also known as: saline solution

Placebo/MenACWY

MenACWY BIOLOGICAL

Subjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 months.

Also known as: Menveo

Placebo/MenACWY

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment.
• Female subjects of childbearing potential must have a negative urine pregnancy test.

You may not qualify if:

• Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine.
• Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization.

Sponsors & Collaborators

• Novartis Vaccines: lead
• GlaxoSmithKline: collaborator

Study Sites (8)

Accelovance, Inc

Huntsville, Alabama, 35802, United States

Location

The Children's Clinic of Jonesboro, P.A.

Jonesboro, Arkansas, 72401, United States

Location

Accelovance, Inc

Melbourne, Florida, 32935, United States

Location

Heartland Research Associates LLC

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Bluegrass Clinical Research, Inc.

Louisville, Kentucky, 40291, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Senders Pediatrics

Cleveland, Ohio, 44121, United States

Location

Related Publications (4)

• Adu-Bobie J, Capecchi B, Serruto D, Rappuoli R, Pizza M. Two years into reverse vaccinology. Vaccine. 2003 Jan 30;21(7-8):605-10. doi: 10.1016/s0264-410x(02)00566-2.

  PMID: 12531326 BACKGROUND

• Bai X, Findlow J, Borrow R. Recombinant protein meningococcal serogroup B vaccine combined with outer membrane vesicles. Expert Opin Biol Ther. 2011 Jul;11(7):969-85. doi: 10.1517/14712598.2011.585965. Epub 2011 May 26.

  PMID: 21615224 BACKGROUND

• Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.

  PMID: 35257644 DERIVED

• Welsch JA, Senders S, Essink B, Klein T, Smolenov I, Pedotti P, Barbi S, Verma B, Toneatto D. Breadth of coverage against a panel of 110 invasive disease isolates, immunogenicity and safety for 2 and 3 doses of an investigational MenABCWY vaccine in US adolescents - Results from a randomized, controlled, observer-blind phase II study. Vaccine. 2018 Aug 23;36(35):5309-5317. doi: 10.1016/j.vaccine.2018.07.016. Epub 2018 Jul 27.

  PMID: 30061029 DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Saline Solution; MenACWY; Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 16, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2015
• Last Updated: September 12, 2018
• Results First Posted: June 26, 2018

Record last verified: 2018-08

Locations

US (8)