Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia

NCT01725217 | Completed Phase 3 Results

• 1 other identifier: V59_50
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 4

Brief Summary

To evaluate the immune response and safety following a single dose of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.

Conditions

Meningococcal Disease

Keywords

Meningitis; children; adolescents; adults; MenACWY

Outcome Measures

Primary Outcomes (1)

• Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination

  Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29). The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA \<1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4

  Day 29

Secondary Outcomes (6)

• Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group

  Day 29

• Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination

  Days 1 and 29

• Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination

  Days 1 and 29

• Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination

  Within days 1 through 7 postvaccination

• Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination

  Within days 1 through 7 postvaccination

Study Arms (1)

MenACWY-CRM

EXPERIMENTAL

MenACWY-CRM

Biological: MenACWY-CRM

Interventions

MenACWY-CRM BIOLOGICAL

1 vaccination at visit 1, conjugate vaccine, Intramuscular (IM) injection

MenACWY-CRM

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals eligible for enrollment in this study were those:
• Who were of any gender, from the age of 2 years and above at the time of visit 1, and to whom the nature of the study had been described and:
• the parent/legal representative had provided written informed consent (≥2 to \<18 years of age),
• had provided written assent (≥11 to \<18 years of age),
• had provided written informed consent (≥18 years of age onwards).
• Who the investigator believed that the subject and/or his or her parent/legal representative could and would comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit).
• Who were in good health as determined by
• medical history
• physical exam
• clinical judgment of the investigator
• Who had a negative urine pregnancy test for female subjects from 11 years of age.

You may not qualify if:

• Individuals not eligible to be enrolled in the study were those:
• Who were unwilling or unable to give written informed assent or consent to participate in the study.
• Who were perceived to be unreliable or unavailable for the duration of the study period.
• Who had a previous confirmed or suspected disease caused by N meningitidis.
• Who had household contact with and/or intimate exposure to an individual with culture-proven N meningitidis infection within 60 days prior to enrollment.
• Who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
• Who were pregnant or breast feeding (female subjects).
• Who had received any investigational or non-registered product (drug or vaccine) within 28 days prior to enrollment or who expected to receive an investigational drug or vaccine prior to the completion of the study.
• Who had received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine within 30 days from the study vaccines.
• (Exception: Influenza vaccine might be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination).
• Who had experienced within the 7 days prior to enrollment significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment.
• Who had any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition). Who had epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
• Who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components including diphtheria toxin (CRM-197) and latex in the syringe.
• Who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
• receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose \> 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy)

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (4)

Federal State Budgetary Institution 'State Scientific Center 'Institution of Immunology' of the Russian Federal Biomedical Agency'

Kashirskoye Highway, Moscow, 115478, Russia

Location

Institution of the Russian Academy of Sciences "Scientific Center for Children Health RAMS"

Lomonosovskiy Avenue, Moscow, 119991, Russia

Location

Federal Budgetary Institution of Science 'St-Petersburg Scientific-Research Institution of Epidemiology and Microbiology by name of Pasteur'

Mira Street, Sankt-Peterburg, 197101, Russia

Location

Federal State Institution 'Scientific-Research Institution of Children's Infections of the Russian Federal Biomedical Agency'

Prof.Popova Street, Sankt-Peterburg, 197022, Russia

Location

Related Publications (1)

• Trotter CL, Andrews NJ, Kaczmarski EB, Miller E, Ramsay ME. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet. 2004 Jul 24-30;364(9431):365-7. doi: 10.1016/S0140-6736(04)16725-1.

  PMID: 15276396 BACKGROUND

MeSH Terms

Conditions

Meningococcal Infections; Meningitis

Interventions

MenACWY-CRM vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuroinflammatory Diseases; Nervous System Diseases

Results Point of Contact

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

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines and Diagnostics

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 12, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 28, 2023
• Results First Posted: March 18, 2014

Record last verified: 2023-04

Locations

RU (4)