Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL® - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00355121

Purpose

The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine.

The main objectives are:

Immunogenicity:

To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone.

Safety:

To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.

Condition	Intervention	Phase
Meningococcal Meningitis Tetanus Diphtheria Pertussis Poliomyelitis	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Immunogenicity and Safety of Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Children Aged 4 to 6 Years in the US When Administered Concomitantly With a Fifth Dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Meningitis Polio and Post-Polio Syndrome Tetanus Whooping Cough

Drug Information available for: Diphtheria vaccine Boostrix Inactivated Poliomyelitis Vaccine Adacel Meningococcal Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination [ Time Frame: Day 30 post-vaccination (Visit 1) ] [ Designated as safety issue: No ]
Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. [ Time Frame: Day 30 post-vaccination (Visit 1) ] [ Designated as safety issue: No ]
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)

Secondary Outcome Measures:

Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 [ Time Frame: Day 30 post-vaccination 1 ] [ Designated as safety issue: No ]
Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination [ Time Frame: Day 30 post-vaccination ] [ Designated as safety issue: No ]
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine [ Time Frame: Day 0 through Day 7 post-vaccination at Visit 1 ] [ Designated as safety issue: No ]
Fever was defined as a maximum oral temperature of ≥ 100.4ºF.

Enrollment:	882
Study Start Date:	October 2006
Study Completion Date:	July 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 DAPTACEL® + IPOL on Day 0 and Menactra on Day 30	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30) Other Names: Menactra® DAPTACEL® IPOL
Experimental: Group 2 DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30) Other Names: Menactra® DAPTACEL® IPOL
Experimental: Group 3 Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30) Other Names: Menactra® DAPTACEL® IPOL

Eligibility

Ages Eligible for Study:	4 Years to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy, as determined by medical history and physical examination.
Aged 4 to < 7 years at the time of study vaccination on Day 0.
Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian.
Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series.

Exclusion Criteria:

Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic)
Known or suspected impairment of immunologic function
Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment
History of documented invasive meningococcal disease or previous meningococcal vaccination
Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study.
Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting < 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrollment.
Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw.
Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances.
Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.
Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
Enrolled in another clinical trial.
Diagnosed with any condition, which, in the opinion of the physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study.
Personal or family history of Guillain-Barré Syndrome (GBS).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355121

Show 26 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00355121 History of Changes
Other Study ID Numbers:	MTA43
Study First Received:	July 20, 2006
Results First Received:	July 25, 2011
Last Updated:	August 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Meningococcal meningitis
Tetanus
Diphtheria

Pertussis
Poliomyelitis
Neisseria meningitidis

Additional relevant MeSH terms:

Diphtheria
Meningitis
Meningitis, Meningococcal
Whooping Cough
Poliomyelitis
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial

Central Nervous System Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bordetella Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases

ClinicalTrials.gov processed this record on May 24, 2012