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

NCT01659996 | Completed Phase 4 Results

• 2 other identifiers: MTA55U1111-1120-1368
• Study Type: interventional
• Target: 1,394
• Locations: 2 countries
• Sites: 58

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.

Conditions

Meningitis; Meningococcal Infection; Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Serotype b (Hib)

Keywords

Meningitis; Meningococcal Infection; Diphtheria; Pertussis; Menactra®; Pentacel®

Outcome Measures

Primary Outcomes (4)

• Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination

  Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (hSBA or SBA-HC). Menactra vaccine response defined as subjects with an hSBA titer \<1:8 at baseline achieving an hSBA titer ≥1:8, and subjects with an hSBA titer ≥1:8 at baseline achieving a ≥ 4-fold increase in hSBA titer.

  Day 30 post second Menactra vaccination

• Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine

  Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).

  Day 30 post-vaccination 2

• Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine

  Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), and Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Pertussis response was defined as: ≥4 × baseline concentration, if the anti-pertussis antibody concentration at baseline is \<4 × lower limit of quantification (LLOQ), Or ≥2 × baseline concentration, if the anti-pertussis antibody concentration at baseline is ≥4 × LLOQ

  Day 30 post-vaccination 2

• 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

  Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA), anti-polyribosylribitol phosphate (PRP) antibodies were measured using a Farr-type radioimmunoassay, and anti-diphtheria antibodies were measured by a toxin neutralization test. The vaccine responses were defined as: Anti-PRP antibody concentrations ≥1.0 μg/mL; Anti-tetanus antibody concentrations ≥1.0 IU/mL and Anti-diphtheria antibody concentrations ≥1.0 IU/mL, respectively, 30 days after vaccination with Pentacel® in participants in Groups 2 and 3.

  Day 30 post-vaccination 2

Other Outcomes (5)

• Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine

  Day 0 (pre-vaccination) and Day 30 post-vaccination 2

• 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

  Day 0 (pre-vaccination) and Day 30 post-vaccination 2

• Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine

  Day 0 to Day 7 after any vaccination

Study Arms (3)

Menactra Vaccine Group

EXPERIMENTAL

Participants will receive Meningococcal polysaccharide diphtheria toxoid conjugate (Menactra®) at 9 months of age and Menactra® at 15 to 18 months of age.

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Menactra and Pentacel Vaccine Group

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.

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed

Pentacel Vaccine Group

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.

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate

Interventions

Meningococcal polysaccharide diphtheria toxoid conjugate + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®, Pentacel®

Menactra and Pentacel Vaccine Group

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Pentacel®

Pentacel Vaccine Group

Meningococcal polysaccharide diphtheria toxoid conjugate BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®

Menactra Vaccine Group

Eligibility Criteria

• Age: 9 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (58)

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Birmingham, Alabama, 35235, United States

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Pinson, Alabama, 35126, United States

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Tucson, Arizona, 85741, United States

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Fayetteville, Arkansas, 72703, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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Chino, California, 91710, United States

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Downey, California, 90241, United States

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La Puente, California, 91744, United States

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Lakewood, California, 90711, United States

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Paramount, California, 90723, United States

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Norwich, Connecticut, 06360, United States

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Marietta, Georgia, 30062, United States

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Woodstock, Georgia, 30189, United States

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DeKalb, Illinois, 60115, United States

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Indianapolis, Indiana, 46256, United States

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Bossier City, Louisiana, 71111, United States

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Woburn, Massachusetts, 01801, United States

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Worcester, Massachusetts, 01655, United States

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Bridgeton, Missouri, 63044, United States

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Kansas City, Missouri, 64114, United States

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Elkhorn, Nebraska, 68022, United States

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Lincoln, Nebraska, 68504, United States

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Lincoln, Nebraska, 68516, United States

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Omaha, Nebraska, 68198, United States

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Clyde, North Carolina, 28721, United States

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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45245, United States

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Fairfield, Ohio, 45014, United States

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Huber Heights, Ohio, 45424, United States

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Kettering, Ohio, 45420, United States

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Tulsa, Oklahoma, 74127, United States

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Erie, Pennsylvania, 16505, United States

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Harleysville, Pennsylvania, 19438, United States

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Hermitage, Pennsylvania, 16148, United States

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Scranton, Pennsylvania, 18510, United States

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Sellersville, Pennsylvania, 18960, United States

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Jackson, Tennessee, 38305, United States

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Kingsport, Tennessee, 37660, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75230, United States

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Fort Worth, Texas, 76107, United States

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Houston, Texas, 77055, United States

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Hurst, Texas, 76054, United States

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San Antonio, Texas, 78229, United States

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Layton, Utah, 84041, United States

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Layton, Utah, 84047, United States

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Murray, Utah, 84107, United States

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Orem, Utah, 84057, United States

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Payson, Utah, 84651, United States

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Roy, Utah, 84067, United States

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Spanish Fork, Utah, 84660, United States

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Syracuse, Utah, 84075, United States

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Midlothian, Virginia, 23113, United States

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Spokane, Washington, 99202, United States

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Spokane, Washington, 99218, United States

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Ponce, PR, 00731, Puerto Rico

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San Juan, PR, 00918, Puerto Rico

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Related Links

• Related Info

MeSH Terms

Conditions

Meningitis; Meningococcal Infections; Diphtheria; Tetanus; Whooping Cough; Haemophilus Infections

Interventions

Meningococcal Vaccines; Tetanus Toxoid; pentacel

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Clostridium Infections; Bordetella Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pasteurellaceae Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Toxoids

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 8, 2012
• Study Start: July 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: September 1, 2015
• Last Updated: December 15, 2015
• Results First Posted: December 15, 2015

Record last verified: 2015-11

Locations

PR (2); US (56)