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

NCT01732627 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: MET44U1111-1127-6804
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 12

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.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections; Invasive Meningococcal Disease

Keywords

Meningitis; Meningococcal Meningitis; Menactra®; Menomune® A/C/Y/W 135

Outcome Measures

Primary Outcomes (13)

• Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine

  Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.

  Day 0 (pre-vaccination)

• Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine

  Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.

  Day 30 (post-vaccination)

• Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine

  Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.

  Day 30 (post-vaccination)

• Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine

  GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.

  Day 0 (pre-vaccination)

• Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine

  GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.

  Day 30 (post-vaccination)

• Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®

  Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.

  Day 0 (pre-vaccination)

• Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®

  Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.

  Day 30 (post-vaccination)

• Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine

  Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers \<1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.

  Day 30 (post-vaccination)

• Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine

  GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.

  Day 0 (pre-vaccination)

• Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine

  GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.

  Day 30 (post-vaccination)

• Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination

  An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.

  Within 30 minutes after vaccination

• Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination

  A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.

  Within 7 days after vaccination

• Number of Participants With Unsolicited Adverse Events After Vaccination

  An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE.

  Within 30 days after vaccination

Study Arms (2)

Group 1: MenACYW Conjugate Vaccine

EXPERIMENTAL

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.

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

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

ACTIVE COMPARATOR

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.

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

Interventions

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

0.5 milliliter (mL), Intramuscular (IM)

Also known as: MenACYW Conjugate Vaccine

Group 1: MenACYW Conjugate Vaccine

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

0.5 mL, Subcutaneous (SC)

Also known as: Menomune® A/C/Y/W 135

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

Eligibility Criteria

• Age: 56 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent form had been signed and dated.
• Able to attend all scheduled visits and complied with all trial procedures.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (12)

Unknown Facility

Chandler, Arizona, 85224, United States

Location

Unknown Facility

Scottsdale, Arizona, 85251, United States

Location

Unknown Facility

Denver, Colorado, 80239, United States

Location

Unknown Facility

Milford, Connecticut, 06460, United States

Location

Unknown Facility

Edina, Minnesota, 55435, United States

Location

Unknown Facility

St Louis, Missouri, 63141, United States

Location

Unknown Facility

Columbus, Ohio, 43212, United States

Location

Unknown Facility

Anderson, South Carolina, 29621, United States

Location

Unknown Facility

Murray, Utah, 84123, United States

Location

Unknown Facility

Salt Lake City, Utah, 84124, United States

Location

Unknown Facility

West Jordan, Utah, 84088, United States

Location

Unknown Facility

Charlottesville, Virginia, 22911, United States

Location

Related Publications (1)

• 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.

  PMID: 32233961 RESULT

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: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 26, 2012
• Study Start: November 12, 2012
• Primary Completion: January 17, 2013
• Study Completion: January 17, 2013
• Last Updated: April 4, 2022
• Results First Posted: June 9, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (12)