Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® Vaccine Approximately Three Years Following Initial Vaccination in Adults Who Participated in Trial MTA29
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Meningitis
- Sponsor
- Sanofi
- Enrollment
- 139
- Primary Endpoint
- Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial MTA29 (NCT00874549).
Objectives:
- To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination.
- To evaluate persistence of serum bactericidal antibodies in subjects who received Menactra® or Menomune® vaccine approximately three years ago.
- To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects re-vaccinated with either Menactra® or Menomune® vaccine.
Detailed Description
Participants who were randomized and received either Menactra® or Menomune® vaccine in trial MTA29 will receive 1 dose of either Menactra® or Menomune®, respectively on Day 0 and will be followed-up for 28 days post-vaccination.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 56 years or older on the day of inclusion.
- •Received the appropriate Menactra or Menomune vaccine as assigned by randomization in Trial MTA
- •Ambulatory and healthy, as determined by medical history.
- •Informed consent form has been signed and dated.
- •Able to attend all scheduled visits and to comply with all trial procedures.
- •For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.
Exclusion Criteria
- •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.
- •Known pregnancy, or a positive pregnancy test.
- •Currently breastfeeding a child.
- •History of documented invasive meningococcal disease.
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination.
- •Planned participation in another clinical trial during the present trial period.
- •Receipt of any meningococcal vaccine since participation in trial MTA
- •Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least two weeks before trial vaccination.
- •Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
- •Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
Outcomes
Primary Outcomes
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Time Frame: Day 0 to Day 7 post-vaccination
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - \> 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF.