Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older

NCT ID: NCT01732627

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-12
• Study Completion Date: 2013-01-17

Brief Summary

Primary objectives:

• To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135.
• To describe the safety profile of a single dose of MenACYW Conjugate vaccine or Menomune® - A/C/Y/W 135.

Detailed Description

All participants received a single dose of their assigned vaccine on Day 0. They were assessed for immunogenicity on Day 0 and Day 30, and monitored for safety throughout the study.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections; Invasive Meningococcal Disease

Study Design

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

Study Groups

Group 1: MenACYW Conjugate Vaccine

Adult participants aged greater than or equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.

Group Type: EXPERIMENTAL

Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5 milliliter (mL), Intramuscular (IM)

Group 2: Menomune® A/C/Y/W 135 vaccine

Adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined (Menomune®) vaccine on Day 0.

Group Type: ACTIVE_COMPARATOR

Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined

Intervention Type: BIOLOGICAL

0.5 mL, Subcutaneous (SC)

Interventions

Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine

0.5 milliliter (mL), Intramuscular (IM)

Intervention Type: BIOLOGICAL

Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined

0.5 mL, Subcutaneous (SC)

Intervention Type: BIOLOGICAL

Other Intervention Names

MenACYW Conjugate Vaccine; Menomune® A/C/Y/W 135

Eligibility Criteria

Inclusion Criteria

• Aged 56 or older on the day of inclusion.
• Informed consent form had been signed and dated.
• Able to attend all scheduled visits and complied with all trial procedures.

Exclusion Criteria

• Participant was pregnant, or lactating, or of childbearing potential (were considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination).
• Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination except for influenza vaccination, which might be received at least 2 weeks before or after the study vaccines.
• Previous vaccination against meningococcal disease with either a trial vaccine or another vaccine.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• 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 (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
• At high risk for meningococcal infection during the trial.
• Known systemic hypersensitivity to latex or any of the vaccine components, or history of a severe reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
• Personal history of Guillain-Barré syndrome.
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination.
• Self-reported thrombocytopenia, contraindicating IM vaccination.
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating 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.
• Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.
• Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°Fahrenheit [≥ 38.0°Celsius]). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
• Receipt of oral or injectable antibiotic therapy within 3 days prior to any blood draw. Should a participant receive oral or injectable antibiotic therapy within 3 days prior to any blood draw, the Investigator would postpone the blood draw until it had been 3 days since the participant last received oral or injectable antibiotic therapy. Postponement must still be within the timeframe for blood draw indicated in the Table of Study Procedures, when possible.
• Identified as an Investigator or employee of the Investigator or study center 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.

• Minimum Eligible Age: 56 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 Inc.

Locations

Chandler, Arizona, United States

Scottsdale, Arizona, United States

Denver, Colorado, United States

Milford, Connecticut, United States

Edina, Minnesota, United States

St Louis, Missouri, United States

Columbus, Ohio, United States

Anderson, South Carolina, United States

Murray, Utah, United States

Salt Lake City, Utah, United States

West Jordan, Utah, United States

Charlottesville, Virginia, United States

Countries

United States

References

Kirstein J, Pina M, Pan J, Jordanov E, Dhingra MS. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized study. Hum Vaccin Immunother. 2020 Jun 2;16(6):1299-1305. doi: 10.1080/21645515.2020.1733868. Epub 2020 Apr 1.

Reference Type: RESULT

PMID: 32233961 (View on PubMed)

Other Identifiers

U1111-1127-6804

Identifier Type: OTHER

Identifier Source: secondary_id

MET44

Identifier Type: -

Identifier Source: org_study_id