- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02640404
Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam
December 6, 2017 updated by: Sanofi Pasteur, a Sanofi Company
Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects Aged 9 Months to 55 Years in Vietnam
The aim of the study is to assess the safety of Menactra vaccine in infants, toddlers, children, adolescents, and adults
Objective:
- To describe the safety profile after each and any dose (when applicable) of Menactra vaccine in participants aged 9 months to 55 years for registration.
Study Overview
Status
Completed
Detailed Description
Infants and toddlers will receive 2 doses of vaccine 3 months apart.
Children ≥ 2 years through adults aged 55 years will receive 1 dose of vaccine.
All participants will be evaluated for safety up to 28 days post-vaccination.
Study Type
Interventional
Enrollment (Actual)
224
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vinh Long Province
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Vinh Long, Vinh Long Province, Vietnam
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 months to 55 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 9 months to 55 years on the day of the first study visit
- For adults: Informed consent form had been signed and dated by the participant For minors: Informed consent form had been signed and dated by the parent or legally acceptable representative. In addition, in accordance with the Independent Ethics Committee /Institutional Review Board requirements and as appropriate for the age of the participant, the participant may be required to sign and date the informed consent form if aged 12 to 17 years or assent form if aged 8 to 11 years
- Participant and/or parent/legally acceptable representative (if applicable) were able to attend all scheduled visits and to comply with all study procedures
Exclusion Criteria:
- Participation at the time of study enrollment (or in the 4 weeks preceding study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following study vaccination
- 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 mg/kg/day prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances
- Laboratory-confirmed, self-reported, or known (as reported by the parent/legally acceptable representative) thrombocytopenia, contraindicating intramuscular vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- Personal history of Guillain-Barré syndrome
- Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with study conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 37.5°C or ≤ 35.5°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event had subsided
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
- Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Menactra® Vaccine (9 to 23 Months)
Participants (infants and toddlers) received 2-dose series of study vaccine with 3-month interval (first dose at Day 0 and second dose 3 months after dose 1).
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0.5 mL, Intramuscular. 2 doses 3 months apart
Other Names:
0.5 mL, Intramuscular.
Other Names:
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Experimental: Menactra® Vaccine (2 to 55 Years)
Participants (children, adolescents and adults) received 1 dose of study vaccine at Day 0.
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0.5 mL, Intramuscular. 2 doses 3 months apart
Other Names:
0.5 mL, Intramuscular.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months)
Time Frame: Within 7 days post-vaccination 1, Within 7 days post-vaccination 2
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Solicited injection (Inj.)
site reactions: Tenderness/Pain (Grade 1: minor reaction when Inj. site touched; Grade 2: cries/protests when Inj. site touched; Grade 3: cries when injected limb moved, or the movement of the injected limb is reduced), Erythema and Swelling (Grade 1: >0 to <25 mm, Grade 2: >=25 to <50 mm, Grade 3: >=50 mm).
Number of participants with any of the Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.
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Within 7 days post-vaccination 1, Within 7 days post-vaccination 2
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Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years)
Time Frame: Within 7 days post-vaccination
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Solicited injection (Inj.)
site reactions in children (2-11 years), adolescents and adults (12-55 years): Tenderness/Pain (Grade 1: easily tolerated [children], no interference with activity [adolescents and adults]; Grade 2: sufficiently discomforting [children], some interference[adolescents and adults]; Grade 3: unable to perform usual activities[children]; significant interference with daily activities [adolescents and adults]), Erythema and Swelling (Grade 1: >0 to<25 mm [children], >=25 to <=50 mm [adolescents and adults]; Grade 2: >=25 to <50 mm [children], >=51 to <=100 mm [adolescents and adults], Grade 3: >=50 mm [children]; >100 mm[adolescents and adults]).
Number of participants with any of Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.
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Within 7 days post-vaccination
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Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months)
Time Frame: Within 7 days post-vaccination 1, Within 7 days post-vaccination 2
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Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius to <=38.5 degree Celsius; Grade 2: >38.5 degree Celsius to <=39.5 degree Celsius; Grade 3: >39.5 degree Celsius), Vomiting (Grade 1: 1 episode per 24 hours, Grade 2: 2-5 episodes per 24 hours, Grade 3: >=6 episodes per 24 hours), Crying abnormal (Grade 1: <1 hour; Grade 2: 1-3 hours; Grade 3: >3 hours), Drowsiness (Grade 1: sleepier than usual or less interested in surroundings; Grade 2: Not interested in surroundings or did not wake up for a feed / meal; Grade 3: Sleeping most of the time or difficult to wake up), Appetite loss (Grade 1: eating less than normal; Grade 2: missed 1 or 2 feeds / meals completely; Grade 3: refuses >=3 feeds / meals or refuses most feeds / meals), Irritability (Grade 1: easily consolable; Grade 2: requiring increased attention; Grade 3: inconsolable).
Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.
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Within 7 days post-vaccination 1, Within 7 days post-vaccination 2
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Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years)
Time Frame: Within 7 days post-vaccination
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Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius to <=38.4 degree Celsius; Grade 2: >=38.5 degree Celsius to <=38.9 degree Celsius; Grade 3: >=39.0 degree Celsius), headache, malaise and myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference).
Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.
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Within 7 days post-vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Sanofi Pasteur Asia Pacific
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 6, 2016
Primary Completion (Actual)
December 5, 2016
Study Completion (Actual)
December 5, 2016
Study Registration Dates
First Submitted
December 22, 2015
First Submitted That Met QC Criteria
December 22, 2015
First Posted (Estimate)
December 29, 2015
Study Record Updates
Last Update Posted (Actual)
January 8, 2018
Last Update Submitted That Met QC Criteria
December 6, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Central Nervous System Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Corynebacterium Infections
- Meningitis, Bacterial
- Central Nervous System Bacterial Infections
- Neisseriaceae Infections
- Diphtheria
- Meningitis, Meningococcal
- Meningitis
- Meningococcal Infections
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- MTA90
- U1111-1143-9207 (Other Identifier: WHO)
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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