Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age



Status:Completed
Conditions:Influenza, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:July 2012
End Date:September 2015

Use our guide to learn which trials are right for you!

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.

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.

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.

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.
We found this trial at
54
sites
735
mi
from 02139
Cincinnati, OH
Click here to add this to my saved trials
1695
mi
from 02139
Austin, TX
Click here to add this to my saved trials
1048
mi
from 02139
Birmingham, AL
Click here to add this to my saved trials
1409
mi
from 02139
Bossier City, LA
Click here to add this to my saved trials
1040
mi
from 02139
Bridgeton, MO
Click here to add this to my saved trials
2561
mi
from 02139
Chino, CA
Click here to add this to my saved trials
789
mi
from 02139
Clyde, NC
Click here to add this to my saved trials
1546
mi
from 02139
Dallas, TX
Click here to add this to my saved trials
902
mi
from 02139
DeKalb, IL
Click here to add this to my saved trials
2586
mi
from 02139
Downey, CA
Click here to add this to my saved trials
1291
mi
from 02139
Elkhorn, NE
Click here to add this to my saved trials
460
mi
from 02139
Erie, PA
Click here to add this to my saved trials
732
mi
from 02139
Fairfield, OH
Click here to add this to my saved trials
1315
mi
from 02139
Fargo, ND
Click here to add this to my saved trials
1300
mi
from 02139
Fayetteville, AR
Click here to add this to my saved trials
1574
mi
from 02139
Fort Worth, TX
Click here to add this to my saved trials
265
mi
from 02139
Harleysville, PA
Click here to add this to my saved trials
487
mi
from 02139
Hermitage, PA
Click here to add this to my saved trials
1601
mi
from 02139
Houston, TX
Click here to add this to my saved trials
699
mi
from 02139
Huber Heights, OH
Click here to add this to my saved trials
1563
mi
from 02139
Hurst, TX
Click here to add this to my saved trials
802
mi
from 02139
Indianapolis, IN
Click here to add this to my saved trials
1053
mi
from 02139
Jackson, TN
Click here to add this to my saved trials
1140
mi
from 02139
Jonesboro, AR
Click here to add this to my saved trials
1245
mi
from 02139
Kansas City, MO
Click here to add this to my saved trials
704
mi
from 02139
Kettering, OH
Click here to add this to my saved trials
730
mi
from 02139
Kingsport, TN
Click here to add this to my saved trials
2574
mi
from 02139
La Puente, CA
Click here to add this to my saved trials
2589
mi
from 02139
Lakewood, CA
Click here to add this to my saved trials
2089
mi
from 02139
Layton, UT
Click here to add this to my saved trials
1322
mi
from 02139
Lincoln, NE
Click here to add this to my saved trials
1254
mi
from 02139
Little Rock, AR
Click here to add this to my saved trials
932
mi
from 02139
Marietta, GA
Click here to add this to my saved trials
482
mi
from 02139
Midlothian, VA
Click here to add this to my saved trials
2092
mi
from 02139
Murray, UT
Click here to add this to my saved trials
76
mi
from 02139
Norwich, CT
Click here to add this to my saved trials
1276
mi
from 02139
Omaha, NE
Click here to add this to my saved trials
2090
mi
from 02139
Orem, UT
Click here to add this to my saved trials
2589
mi
from 02139
Paramount, CA
Click here to add this to my saved trials
2097
mi
from 02139
Payson, UT
Click here to add this to my saved trials
1035
mi
from 02139
Pinson, AL
Click here to add this to my saved trials
1703
mi
from 02139
Ponce,
Click here to add this to my saved trials
2090
mi
from 02139
Roy, UT
Click here to add this to my saved trials
1769
mi
from 02139
San Antonio, TX
Click here to add this to my saved trials
243
mi
from 02139
Scranton, PA
Click here to add this to my saved trials
Sellersville, Pennsylvania 18960
258
mi
from 02139
Sellersville, PA
Click here to add this to my saved trials
2092
mi
from 02139
Spanish Fork, UT
Click here to add this to my saved trials
2256
mi
from 02139
Spokane, WA
Click here to add this to my saved trials
2093
mi
from 02139
Syracuse, UT
Click here to add this to my saved trials
2275
mi
from 02139
Tucson, AZ
Click here to add this to my saved trials
1393
mi
from 02139
Tulsa, OK
Click here to add this to my saved trials
8
mi
from 02139
Woburn, MA
Click here to add this to my saved trials
923
mi
from 02139
Woodstock, GA
Click here to add this to my saved trials
36
mi
from 02139
Worcester, MA
Click here to add this to my saved trials