Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age
NCT ID: NCT01659996
Last Updated: 2015-12-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
1394 participants
INTERVENTIONAL
2012-07-31
2015-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Primary Objectives:
* To evaluate and compare the antibody responses to meningococcal serogroups A, C, Y, and W-135 induced by 2 injections of Menactra® in subjects aged 9 months at the first vaccination visit and 15 to 18 months at the second vaccination visit.
* To evaluate and compare the antibody responses to Pertussis (pertussis toxoid \[PT\], filamentous haemagglutinin \[FHA\] and pertactin \[PRN\]) antigens induced by a dose of Pentacel® when administered concomitantly with Menactra® to those elicited by a dose of Pentacel® administered alone.
* To evaluate and compare the antibody responses to polyribosylribitol phosphate (PRP), tetanus and diphtheria antigens induced by a dose of Pentacel® when administered concomitantly with Menactra® to those elicited by a dose of Pentacel® alone.
Observational Objectives:
* To describe the safety profile (immediate unsolicited AEs within 30 minutes of each trial vaccination, solicited reactions within 7 days of each vaccination, unsolicited AEs within 30 days of each vaccination, and serious adverse events \[SAEs\] throughout the course of the trial from Day 0 up to Day 30 after the last trial vaccination\[s\]) in all trial groups
* To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by SBA HC, 30 days after the second Menactra® administration
* To describe the antibody responses to Pentacel® (PT, FHA, PRN, FIM, diphtheria, tetanus, polio, PRP) measured by enzyme-linked immunosorbent assay (ELISA), radioimmunoassay (RIA), or functional assays.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Menactra Vaccine Group
Participants will receive Meningococcal polysaccharide diphtheria toxoid conjugate (Menactra®) at 9 months of age and Menactra® at 15 to 18 months of age.
Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, Intramuscular
Menactra and Pentacel Vaccine Group
Participants will receive Meningococcal polysaccharide diphtheria toxoid conjugate (Menactra®) at 9 months of age and Menactra® + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed (Pentacel®) concomitantly at 15 to 18 months of age.
Meningococcal polysaccharide diphtheria toxoid conjugate + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed
0.5 mL, Intramuscular
Pentacel Vaccine Group
Participants will receive only Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Pentacel®) at 15 to 18 months of age.
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate
0.5 mL, Intramuscular
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, Intramuscular
Meningococcal polysaccharide diphtheria toxoid conjugate + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed
0.5 mL, Intramuscular
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate
0.5 mL, Intramuscular
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
* Received 3 doses of any DTaP-containing vaccines
* Received 3 doses of a Hib-containing vaccine, or 2 doses if the subject received PRP-OMP (PedvaxHIB® or Comvax®\[HepB-Hib\])
* Received at least 3 doses of a CRM197-based pneumococcal conjugate vaccine (Pneumococcal conjugate vaccine \[PCV\] or 13-Valent pneumococcal conjugate vaccine \[PCV13\])
* Subject and parent/ legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
* Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for influenza vaccination, which may be received at least 2 weeks before or after the trial vaccination(s)
* Vaccination against meningococcal disease with either the trial vaccine or another vaccine, or receipt of the 4th dose of any DTaP-containing vaccines, receipt of the 4th dose of a Hib-containing vaccine, or receipt of the 3rd dose of PRP-OMP (PedvaxHIB® or Comvax® \[Hep B-Hib\]) prior to enrollment or during the conduction of the trial, except for Group 1 subjects, who may receive Hib vaccine at 12 months
* 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). Topical steroids are not included in this exclusion criterion
* History of invasive meningococcal infection, confirmed either clinically, serologically, or microbiologically
* Personal history of Guillain-Barré Syndrome
* History of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to one of the vaccines used in the trial or to a vaccine containing any of the same substances
* Known thrombocytopenia, as reported by the parent/ legally acceptable representative, contraindicating intramuscular vaccination
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
* In an emergency setting or hospitalized involuntarily
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
* Moderate or severe acute illness/ infection (according to investigator judgment) or febrile illness (temperature ≥ 100.4°F \[≥ 38.0°C\]) on the day of vaccination. A prospective subject should not be included in the trial until the condition has resolved or the febrile event has subsided
* Receipt of oral or injectable antibiotic therapy within 72 hours prior to any trial blood draw (topical antibiotics, drops, or ointments are not included in this criterion)
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed trial.
9 Months
18 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Pinson, Alabama, United States
Tucson, Arizona, United States
Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Chino, California, United States
Downey, California, United States
La Puente, California, United States
Lakewood, California, United States
Paramount, California, United States
Norwich, Connecticut, United States
Marietta, Georgia, United States
Woodstock, Georgia, United States
DeKalb, Illinois, United States
Indianapolis, Indiana, United States
Bossier City, Louisiana, United States
Woburn, Massachusetts, United States
Worcester, Massachusetts, United States
Bridgeton, Missouri, United States
Kansas City, Missouri, United States
Elkhorn, Nebraska, United States
Lincoln, Nebraska, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Clyde, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Fairfield, Ohio, United States
Huber Heights, Ohio, United States
Kettering, Ohio, United States
Tulsa, Oklahoma, United States
Erie, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Hermitage, Pennsylvania, United States
Scranton, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Jackson, Tennessee, United States
Kingsport, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Hurst, Texas, United States
San Antonio, Texas, United States
Layton, Utah, United States
Layton, Utah, United States
Murray, Utah, United States
Orem, Utah, United States
Payson, Utah, United States
Roy, Utah, United States
Spanish Fork, Utah, United States
Syracuse, Utah, United States
Midlothian, Virginia, United States
Spokane, Washington, United States
Spokane, Washington, United States
Ponce, PR, Puerto Rico
San Juan, PR, Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1120-1368
Identifier Type: OTHER
Identifier Source: secondary_id
MTA55
Identifier Type: -
Identifier Source: org_study_id