Clinical trial NCT01659996: Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age
Official title: An Immunogenicity and Safety Evaluation of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered to Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningitis
Meningococcal Infection
Diphtheria
Tetanus
Pertussis
Haemophilus Influenzae Serotype b (Hib)
Keywords: Meningitis
Meningococcal Infection
Diphtheria
Pertussis
Menactra®
Pentacel®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 1394
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to further characterize the safety and immunogenicity of Menactra® in the population \<2 years of age when administered alone and when the second dose is administered concomitantly with the 4th dose of Pentacel®, a licensed pediatric vaccine.

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: Participants will be vaccinated according to their randomized groups at age 9 months and at age 15 to 18 months. They will undergo immunogenicity assessment and safety monitoring post-vaccination.

Eligibility criteria: Inclusion Criteria:

* Aged 9 months (249 to 305 days) for Groups 1 and 2, or 15 to 18 months (420 to 570 days) for Group 3 on the day of the first trial visit
* 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:

* Participation in the 4 weeks preceding the first 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 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.

Primary outcomes:
measure: Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination
timeFrame: Day 30 post second Menactra vaccination
measure: Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
timeFrame: Day 30 post-vaccination 2
measure: Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
timeFrame: Day 30 post-vaccination 2
measure: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
timeFrame: Day 30 post-vaccination 2
Secondary outcomes:
Other outcomes:
measure: Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 30 post-vaccination 2
measure: Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 30 post-vaccination 2
measure: Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
timeFrame: Day 0 to Day 7 after any vaccination
measure: Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine.
timeFrame: Day 0 to Day 7 after 9-month vaccination
measure: Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine
timeFrame: Day 0 to Day 7 after the 15 to 18 month vaccination
Locations:
city: Birmingham
country: United States
state: Alabama
city: Pinson
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Fayetteville
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Chino
country: United States
state: California
city: Downey
country: United States
state: California
city: La Puente
country: United States
state: California
city: Lakewood
country: United States
state: California
city: Paramount
country: United States
state: California
city: Norwich
country: United States
state: Connecticut
city: Marietta
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Dekalb
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Bossier City
country: United States
state: Louisiana
city: Woburn
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Bridgeton
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Elkhorn
country: United States
state: Nebraska
city: Lincoln
country: United States
state: Nebraska
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Clyde
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Fairfield
country: United States
state: Ohio
city: Huber Heights
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Erie
country: United States
state: Pennsylvania
city: Harleysville
country: United States
state: Pennsylvania
city: Hermitage
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Jackson
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Hurst
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Layton
country: United States
state: Utah
city: Layton
country: United States
state: Utah
city: Murray
country: United States
state: Utah
city: Orem
country: United States
state: Utah
city: Payson
country: United States
state: Utah
city: Roy
country: United States
state: Utah
city: Spanish Fork
country: United States
state: Utah
city: Syracuse
country: United States
state: Utah
city: Midlothian
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: