Meningococcal Meningitis Clinical Trial
Official title:
A Safety and Immunogenicity Evaluation of a Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) and a Meningococcal Polysaccharide Vaccine Groups A, C, Y, and W-135 Combined (Menomune® - A/C/Y/W-135) in Subjects 56 Years of Age or Older
Verified date | September 2013 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 216 |
Est. completion date | October 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 56 Years and older |
Eligibility |
Inclusion Criteria: - Ambulatory and healthy, as determined by medical history. - 56 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. 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. - 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. - Febrile illness within the last 72 hours or an oral temperature = 100.4ºF at the time of inclusion. - 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. - Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. - Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | No | |
Other | 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 | No | |
Other | 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 | No | |
Other | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Day 0 and 28 days Post-vaccination 2 | No | |
Other | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (=1:8) Pre- and Post-vaccination 1 | Day 28 Post-vaccination 1 | No | |
Other | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (=1:8), Pre-vaccination 1 and Post-vaccination 2 | Day 0 and Day 28 Post-vaccination 2 | No | |
Primary | 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 | Yes |
Primary | 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 | Yes |
Primary | 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 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01424644 -
A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
|
Phase 4 | |
Completed |
NCT01434680 -
Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers
|
Phase 2 | |
Completed |
NCT00384397 -
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
|
Phase 3 | |
Completed |
NCT01453348 -
Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
|
Phase 3 | |
Completed |
NCT01214837 -
Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
|
Phase 3 | |
Completed |
NCT00355121 -
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
|
Phase 2 | |
Completed |
NCT02591290 -
Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects
|
Phase 4 | |
Completed |
NCT01717638 -
Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1
|
Phase 3 | |
Completed |
NCT01466387 -
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
|
Phase 3 | |
Completed |
NCT01482052 -
Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis
|
Phase 1 | |
Completed |
NCT01239043 -
Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
|
Phase 2 | |
Completed |
NCT00994695 -
Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine
|
Phase 2 | |
Completed |
NCT01732627 -
Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older
|
Phase 2 | |
Completed |
NCT01478347 -
A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults
|
Phase 3 | |
Completed |
NCT00483574 -
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
|
Phase 3 | |
Completed |
NCT00474487 -
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults
|
Phase 3 | |
Completed |
NCT03205358 -
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers
|
Phase 2 | |
Not yet recruiting |
NCT06226714 -
A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds
|
Phase 3 | |
Completed |
NCT00667602 -
Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
|
Phase 3 | |
Completed |
NCT00450437 -
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
|
Phase 3 |