Overview

This trial is active, not recruiting.

Conditions meningitis, meningococcal infection, diphtheria, tetanus, pertussis, haemophilus influenzae serotype b (hib)
Treatments meningococcal polysaccharide diphtheria toxoid conjugate, meningococcal polysaccharide diphtheria toxoid conjugate + diphtheria and tetanus toxoids and acellular pertussis adsorbed, diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and haemophilus b conjugate
Phase phase 4
Sponsor Sanofi Pasteur, a Sanofi Company
Start date July 2012
End date November 2014
Trial size 1394 participants
Trial identifier NCT01659996, MTA55, U1111-1120-1368

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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 Menactra®
0.5 mL, Intramuscular
(Experimental)
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 Menactra®
0.5 mL, Intramuscular
(Active Comparator)
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 Pentacel®
0.5 mL, Intramuscular

Primary Outcomes

Measure
Percentage of participants with Serum antibody titers to meningococcal serogroups A, C, Y, and W 135 at ≥ 1:8 after the second Menactra® vaccination.
time frame: 30 days post-second vaccination.
Geometric mean concentration of antibodies to pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), fimbriae types 2 and 3 (FIM) in participants at baseline and 30 days after vaccination with Pentacel®
time frame: 30 days post-vaccination.

Secondary Outcomes

Measure
Percentage of participants reporting solicited injection site reactions, solicited and unsolicited systemic reactions, unsolicited adverse events and serious adverse events occurring throughout the trial.
time frame: Day 0 up to 30 days post-vaccination

Eligibility Criteria

Male or female participants from 9 months up to 18 months old.

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.

Additional Information

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.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Sanofi.