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

• ClinicalTrials.gov Identifier: NCT02640404
• Recruitment Status: Completed
• First Posted: December 29, 2015
• Results First Posted: January 8, 2018
• Last Update Posted: January 8, 2018
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Meningitis; Meningococcal Meningitis; Meningococcal Infections	Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 224 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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 Start Date: June 6, 2016
• Actual Primary Completion Date: December 5, 2016
• Actual Study Completion Date: December 5, 2016

Arms and Interventions

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).	Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL, Intramuscular. 2 doses 3 months apart; Other Name: Menactra®
Experimental: Menactra® Vaccine (2 to 55 Years); Participants (children, adolescents and adults) received 1 dose of study vaccine at Day 0.	Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL, Intramuscular.; Other Name: Menactra®

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.
2. Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) [ Time Frame: Within 7 days post-vaccination ]
   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.
3. 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 ]
   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.
4. Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) [ Time Frame: Within 7 days post-vaccination ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 9 Months to 55 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Vietnam

Vinh Long, Vinh Long Province, Vietnam

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director; Sanofi Pasteur Asia Pacific

More Information

Additional Information:

Related Info 

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT02640404
• Other Study ID Numbers: MTA90; U1111-1143-9207 ( Other Identifier: WHO )
• First Posted: December 29, 2015
• Results First Posted: January 8, 2018
• Last Update Posted: January 8, 2018
• Last Verified: December 2017

• 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

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Meningitis; Meningococcal Meningitis; Meningococcal Infections; Menactra®; Meningococcal Vaccine

Additional relevant MeSH terms:

Diphtheria; Meningococcal Infections; Meningitis, Meningococcal; Meningitis; Infections; Neuroinflammatory Diseases; Nervous System Diseases; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs