Clinical trial NCT02640404: Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningitis
Meningococcal Meningitis
Meningococcal Infections
Keywords: Meningitis
Meningococcal Meningitis
Meningococcal Infections
Menactra®
Meningococcal Vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-12-29
Enrollment: 224
Sex: ALL
Minimum age (years): 9
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months)
timeFrame: Within 7 days post-vaccination 1, Within 7 days post-vaccination 2
measure: Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years)
timeFrame: Within 7 days post-vaccination
measure: Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months)
timeFrame: Within 7 days post-vaccination 1, Within 7 days post-vaccination 2
measure: Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years)
timeFrame: Within 7 days post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Vinh Long
country: Vietnam
state: Vinh Long Province
Study officials:
affiliation: Sanofi Pasteur Asia Pacific
name: Medical Director
role: STUDY_DIRECTOR
References: