Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers
Primary Purpose
Meningitis, Meningococcal Meningitis, Meningococcal Infections
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Meningococcal Polysaccharide groups A, C, W-135 and Y Conjugate Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Meningitis focused on measuring Meningitis, Meningococcal Meningitis, MenACYW Conjugate vaccine, NIMENRIX®
Eligibility Criteria
Inclusion Criteria:
- Aged 12 to 23 months on the day of the first study visit.
- Born at full term of pregnancy (greater than or equal to [≥] 37 weeks) or with a birth weight ≥2.5 kilogram (kg) (5.5 pounds).
- Inform Consent Form (ICF) had been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations).
- Participant and parent/legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures.
- Covered by health insurance where applicable.
Exclusion Criteria:
- Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine before the final blood draw except for influenza vaccination, which might be received at least 2 weeks before or after the study vaccine.
- Previous vaccination against meningococcal disease with either the trial vaccine or mono-, or polyvalent polysaccharide or Conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y.
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (≥ 2 milligram [mg]/kg/day of prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
- At high risk for meningococcal infection during the trial (i.e., participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease).
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
- Known systemic hypersensitivity to latex.
- Known thrombocytopenia, as reported by the parent/legally acceptable representative.
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
- Personal history of Guillain-Barré syndrome.
- Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
- Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥38.0 degree Celsius (°C). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Sites / Locations
- Investigational Site Number 005
- Investigational Site Number 006
- Investigational Site Number 002
- Investigational Site Number 007
- Investigational Site Number 008
- Investigational Site Number 001
- Investigational Site Number 003
- Investigational Site Number 004
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1: MenACYW Conjugate Vaccine
Group 2: NIMENRIX®
Arm Description
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine.
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.
Outcomes
Primary Outcome Measures
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
A solicited reaction was defined as an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the case report form (CRF) and considered as related to vaccination. Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness: cries when injected limb was moved or the movement of the injected limb was reduced; Erythema and Swelling: greater than or equal to (≥) 50 millimeter (mm). Grade 3 solicited systemic reactions: Fever: greater than [>] 39.5 degree Celsius (°C); Vomiting: ≥6 episodes per 24 hours or requiring parenteral hydration; crying abnormal: >3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses ≥3 feeds or refuses most feeds; Irritability: inconsolable.
Secondary Outcome Measures
Full Information
NCT ID
NCT03205358
First Posted
June 28, 2017
Last Updated
March 24, 2022
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT03205358
Brief Title
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers
Official Title
A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2015 (Actual)
Primary Completion Date
August 19, 2015 (Actual)
Study Completion Date
August 19, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study was to evaluate the immunogenicity and safety profile of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when given alone compared to that of the licensed Meningococcal groups A, C, W 135 and Y (NIMENRIX®) Conjugate vaccine.
Observational objectives:
To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using baby rabbit complement (rSBA) and by serum bactericidal assay using human complement (hSBA)
To evaluate the antibody responses against tetanus in participants who received MenACYW Conjugate vaccine or NIMENRIX® vaccine
To evaluate the safety profile of MenACYW Conjugate vaccine and NIMENRIX®
Detailed Description
All participants received 1 dose of MenACYW Conjugate vaccine or NIMENRIX® on Day 0 and were evaluated for immunogenicity and safety profile. The duration of each participant's participation in the trial was 30 to 44 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal Meningitis, Meningococcal Infections
Keywords
Meningitis, Meningococcal Meningitis, MenACYW Conjugate vaccine, NIMENRIX®
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: MenACYW Conjugate Vaccine
Arm Type
Experimental
Arm Description
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine.
Arm Title
Group 2: NIMENRIX®
Arm Type
Active Comparator
Arm Description
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.
Intervention Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Other Intervention Name(s)
MenACYW Conjugate vaccine
Intervention Description
0.5 milliliter (mL), Intramuscular (IM)
Intervention Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide groups A, C, W-135 and Y Conjugate Vaccine
Other Intervention Name(s)
NIMENRIX®
Intervention Description
0.5 mL, IM
Primary Outcome Measure Information:
Title
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Description
A solicited reaction was defined as an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the case report form (CRF) and considered as related to vaccination. Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness: cries when injected limb was moved or the movement of the injected limb was reduced; Erythema and Swelling: greater than or equal to (≥) 50 millimeter (mm). Grade 3 solicited systemic reactions: Fever: greater than [>] 39.5 degree Celsius (°C); Vomiting: ≥6 episodes per 24 hours or requiring parenteral hydration; crying abnormal: >3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses ≥3 feeds or refuses most feeds; Irritability: inconsolable.
Time Frame
Day 0 up to Day 7 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 12 to 23 months on the day of the first study visit.
Born at full term of pregnancy (greater than or equal to [≥] 37 weeks) or with a birth weight ≥2.5 kilogram (kg) (5.5 pounds).
Inform Consent Form (ICF) had been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations).
Participant and parent/legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures.
Covered by health insurance where applicable.
Exclusion Criteria:
Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine before the final blood draw except for influenza vaccination, which might be received at least 2 weeks before or after the study vaccine.
Previous vaccination against meningococcal disease with either the trial vaccine or mono-, or polyvalent polysaccharide or Conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y.
Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (≥ 2 milligram [mg]/kg/day of prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
At high risk for meningococcal infection during the trial (i.e., participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease).
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
Known systemic hypersensitivity to latex.
Known thrombocytopenia, as reported by the parent/legally acceptable representative.
Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
Personal history of Guillain-Barré syndrome.
Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.
Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥38.0 degree Celsius (°C). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 005
City
Espoo
ZIP/Postal Code
02230
Country
Finland
Facility Name
Investigational Site Number 006
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Investigational Site Number 002
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Facility Name
Investigational Site Number 007
City
Järvenpää
ZIP/Postal Code
04400
Country
Finland
Facility Name
Investigational Site Number 008
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Investigational Site Number 001
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Investigational Site Number 003
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Investigational Site Number 004
City
Turku
ZIP/Postal Code
20520
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Citations:
PubMed Identifier
32233959
Citation
Vesikari T, Borrow R, Forsten A, Findlow H, Dhingra MS, Jordanov E. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in healthy toddlers: a Phase II randomized study. Hum Vaccin Immunother. 2020 Jun 2;16(6):1306-1312. doi: 10.1080/21645515.2020.1733869. Epub 2020 Apr 1.
Results Reference
result
Learn more about this trial
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers
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