Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years

NCT00874549 | Completed Phase 1 Results

• 1 other identifier: MTA29
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 6

Brief Summary

Safety: To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune® vaccine. Immunogenicity: To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study groups.

Conditions

Meningococcal Infections; Meningococcal Meningitis

Keywords

Meningococcal Vaccine; Menactra®; Menomune®

Outcome Measures

Primary Outcomes (3)

• Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.

  Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.

  0-7 days post-vaccination 1

• Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2

  Solicited injection site reactions: Pain, Erythema, and Swelling.

  0-7 Days Post-vaccination 2

• Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2

  Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.

  Day 0 to 7 Post-vaccination 2

Other Outcomes (6)

• Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.

  Day 28 Post-vaccination 1

• Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2

  Day 28 Post-vaccination 2

• Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1

  Day 0 and Day 28 Post-vaccination 1

Study Arms (4)

Group 1: Menomune Day 0

ACTIVE COMPARATOR

Participants received a single dose of Menomune® vaccine on Day 0.

Biological: Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide

Group 2: Menactra® Day 0 x 2

EXPERIMENTAL

Participants received two single-dose injections of Menactra® vaccine on Day 0

Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate

Group 3: Menactra® Day 0 and 14

EXPERIMENTAL

Participants received a single dose of Menactra® vaccine on Day 0 and on Day 14

Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate

Group 4: Menactra® Day 0 and 28

EXPERIMENTAL

Participants received a single dose of Menactra® vaccine on Day 0 and on Day 28.

Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate

Interventions

Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide BIOLOGICAL

0.5 mL, Subcutaneous

Also known as: Menomune®

Group 1: Menomune Day 0

Menactra®: Polysaccharide Diphtheria Toxoid Conjugate BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®

Group 2: Menactra® Day 0 x 2

Eligibility Criteria

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

You may qualify if:

• Ambulatory and healthy, as determined by medical history.
• years of age or older at the time of vaccination.
• Signed Institutional Review Board (IRB)-approved informed consent form.
• Able to attend all scheduled visits and to comply with all trial procedures.
• For a woman, inability to become pregnant or a negative urine pregnancy test at the time of enrollment.

You may not qualify if:

• Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
• Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc) that is unstable or that might 1) interfere with the ability to participate fully in the study or 2) interfere with evaluation of the vaccines.
• Known or suspected impairment of immunologic function.
• History of documented invasive meningococcal disease or previous meningococcal vaccination.
• Known or suspected receipt of a diphtheria-containing vaccine within the preceding 2 years.
• Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
• Systemic antibiotic therapy within the 72 hours prior to collection of any blood samples.
• Received any vaccine in the 28-day period prior to enrollment or scheduled to receive any vaccination through Visit 2 for Groups 1 and 2 and through Visit 3 for Groups 3 and 4. Influenza vaccines may be received 2 weeks before or after a study vaccination.
• Suspected or known hypersensitivity to latex or to any of the components of either Menactra® vaccine or Menomune® vaccine.
• Previous personal history of Guillain-Barré syndrome.
• Not available for the entire study period or unable to attend the scheduled visits or to comply with the study procedures.
• In females of childbearing potential, a positive or equivocal urine pregnancy test at enrollment.
• A nursing mother.
• Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.
• Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial visits or procedures.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (6)

Unknown Facility

Scottsdale, Arizona, 85251, United States

Location

Unknown Facility

Bardstown, Kentucky, 40004, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87108, United States

Location

Unknown Facility

West Jordon, Utah, 84088, United States

Location

Unknown Facility

Seattle, Washington, 98101, United States

Location

Unknown Facility

Spokane, Washington, 99202, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

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

  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 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 2, 2009
• Study Start: October 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 20, 2013
• Results First Posted: March 25, 2010

Record last verified: 2013-09

Locations

US (6)