Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
First received: November 8, 2012
Last updated: March 24, 2014
Last verified: March 2014
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Children, Adolescents and Adults in Russia
Primary Outcome Measures:
- Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
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
Secondary Outcome Measures:
- Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM
- Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination [ Time Frame: Days 1 and 29 ] [ Designated as safety issue: No ]
Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group
- Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination [ Time Frame: Days 1 and 29 ] [ Designated as safety issue: No ]
Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group
- Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination [ Time Frame: Within days 1 through 7 postvaccination ] [ Designated as safety issue: Yes ]
Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination
- Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination [ Time Frame: Within days 1 through 7 postvaccination ] [ Designated as safety issue: Yes ]
Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group
- Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination [ Time Frame: AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29 ] [ Designated as safety issue: Yes ]
Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2013 (Final data collection date for primary outcome measure)
1 vaccination at visit 1, conjugate vaccine, Intramuscular (IM) injection
|Ages Eligible for Study:
||2 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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)
- receipt of immunostimulants
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study
- Who were known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01725217
|Federal State Budgetary Institution 'State Scientific Center 'Institution of Immunology' of the Russian Federal Biomedical Agency'
|Kashirskoye highway, Moscow, Russian Federation, 115478 |
|Institution of the Russian Academy of Sciences "Scientific Center for Children Health RAMS"
|Lomonosovskiy avenue, Moscow, Russian Federation, 119991 |
|Federal Budgetary Institution of Science 'St-Petersburg Scientific-Research Institution of Epidemiology and Microbiology by name of Pasteur'
|Mira street, St-Petersburg, Russian Federation, 197101 |
|Federal State Institution 'Scientific-Research Institution of Children's Infections of the Russian Federal Biomedical Agency'
|Prof.Popova street, St-Petersburg, Russian Federation, 197022 |
||Novartis Vaccines and Diagnostics
||Novartis ( Novartis Vaccines )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 8, 2012
|Results First Received:
||February 3, 2014
||March 24, 2014
||Russia: Ministry of Health of the Russian Federation
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 08, 2016
Gram-Negative Bacterial Infections