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

NCT ID: NCT02640404

Last Updated: 2018-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-06
• Study Completion Date: 2016-12-05

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.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular. 2 doses 3 months apart

Menactra® Vaccine (2 to 55 Years)

Participants (children, adolescents and adults) received 1 dose of study vaccine at Day 0.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular.

Interventions

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

0.5 mL, Intramuscular. 2 doses 3 months apart

Intervention Type: BIOLOGICAL

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

0.5 mL, Intramuscular.

Intervention Type: BIOLOGICAL

Other Intervention Names

Menactra®; Menactra®

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

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Asia Pacific

Locations

Vĩnh Long, Vinh Long Province, Vietnam

Countries

Vietnam

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

U1111-1143-9207

Identifier Type: OTHER

Identifier Source: secondary_id

MTA90

Identifier Type: -

Identifier Source: org_study_id