Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects

NCT02591290 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: EFC14375/MTA89U1111-1174-4291
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to collect further information regarding an increase immune response of SP284 after an additional dose in Japanese participants. Primary Objective:

• To evaluate and describe the immune responses to meningococcal antigens (serogroups A,C, Y and W-135) at 28 days following each vaccination with SP284 vaccine in participants 20 through 55 years of age. Other Pre-specified objective:
• To describe the safety in terms of immediate systemic adverse events (AEs), solicited reactions, unsolicited non-serious adverse events, and serious adverse events (SAEs) following receipt of each dose of SP284 vaccine in persons 20 through 55 years of age.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128

  Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by Serum Bactericidal Assay using Baby Rabbit complement (SBA-BR).

  Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2

Other Outcomes (2)

• Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination

  Day 28 post-vaccination 1, Day 28 post-vaccination 2

• Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination

  Within 7 days post-vaccination 1, Within 7 days post-vaccination 2

Study Arms (1)

Menactra® Vaccine

EXPERIMENTAL

Participants received 2-dose series of the study vaccine with 8-week interval.

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

Interventions

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

0.5 mL, Intramuscular (2 doses with 8-week interval)

Also known as: SP284, Menactra®

Menactra® Vaccine

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent form had been signed and dated by the participant,
• Able to attend all scheduled visits and to comply with all trial procedures,
• For female participants who had childbearing potential, use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination
• a) "20 through 55 years" meant from the day of the 20th birthday to the day before the 56th birthday.
• b) To be considered to be not of childbearing potential, a woman must either had undergone surgical sterilization (hysterectomy or bilateral tubal ligation) or be postmenopausal (at least one year without menses) at the time of vaccination. Effective methods of contraception include oral contraception (pill), intrauterine device, diaphragm or condoms used with sponge, contraceptive foam or cream, hormonal implants, transdermal patch, or parenteral contraception.

You may not qualify if:

• Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion,
• History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically,
• Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine,
• Known or suspected congenital or current/ previous acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months),
• Planned participation in another clinical trial during the present trial period,
• Receipt of immune globulins, blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response,
• Receipt of any vaccine within the four weeks preceding the trial vaccination, except for influenza vaccination, which might be received at least two weeks before the study vaccine,
• Planned receipt of any vaccine during the trial period,
• Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus infection,
• 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 the first vaccination and until at least 4 weeks after the last vaccination),
• Known thrombocytopenia, contraindicating intramuscular (IM) vaccination,
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily,
• Current alcohol abuse or drug addiction,
• Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator,
• Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine,

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Osaka, 532-0003, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Meningitis; Meningitis, Meningococcal; Meningococcal Infections

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi KK

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 29, 2015
• Study Start: October 20, 2015
• Primary Completion: March 16, 2016
• Study Completion: March 16, 2016
• Last Updated: November 6, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)