Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02640404
• Date of registration: 22/12/2015
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam
• Scientific 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
• Date of first enrolment: June 6, 2016
• Target sample size: 224
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02640404
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Vietnam

Contacts

• Name: Medical Director
• Affiliation: Sanofi Pasteur Asia Pacific

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged 9 months to 55 years on the day of the first study visit

- For adults: Informed consent form has been signed and dated by the subject. For
minors: Informed consent form has 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 subject, the subject 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.

- Subject and/or parent/legally acceptable representative (if applicable) are 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 (=
2mg/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, is 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 subject should not be included in the study until the condition has
resolved or the febrile event has 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

- Subject is 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



Age minimum: 9 Months
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Meningococcal Meningitis

Meningitis

Meningococcal Infections

Intervention(s)

Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Primary Outcome(s)

Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial [Time Frame: Day 0 up to Day 28 post-vaccination]

Secondary ID(s)

U1111-1143-9207

MTA90

Source(s) of Monetary Support

Please refer to primary and secondary sponsors