Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children

NCT00771849 | Completed Phase 2 Results

• 1 other identifier: MTA15
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

Brief Summary

The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent meningococcal C conjugate vaccine at least one year previously. Primary objective: To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C in participants receiving Menactra® to the serogroup C antibody response in a control group of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28 days following vaccination.

Conditions

Meningitis; Meningococcemia

Keywords

Meningitis; Meningococcemia; Neisseria meningitidis

Outcome Measures

Primary Outcomes (1)

• Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.

  Day 0 (before) and 28 days post-vaccination

Secondary Outcomes (1)

• Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.

  28 days post-vaccination

Study Arms (2)

Menactra® Vaccine Group

EXPERIMENTAL

Participants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Hiberix® Vaccine Group

ACTIVE COMPARATOR

Participants receiving Haemophilus Influenzae Type b (Hib) vaccine

Biological: Haemophilus Influenzae Type b (Hib) vaccine

Interventions

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®

Menactra® Vaccine Group

Haemophilus Influenzae Type b (Hib) vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Hiberix®

Hiberix® Vaccine Group

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participant is healthy, as determined by medical history and physical examination.
• Participant is 2 years to \< 5 years of age at the time of vaccination.
• At least one year from primary vaccination with a monovalent meningococcal C conjugate vaccine has elapsed.
• Parent/Guardian has signed an Ethics Committee-approved informed consent form. A culturally appropriate translation will be used for non-English speaking participants where required.

You may not qualify if:

• Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, etc.)
• Known or suspected impairment of immunologic function
• History of documented invasive meningococcal disease
• Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrolment
• Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to drawing any blood sample
• Received any vaccine in the 28-day period prior to enrolment, or scheduled to receive any vaccine during enrolment in the trial
• Received a meningococcal C conjugate vaccine within one year prior to enrolment
• Suspected or known hypersensitivity to any of the vaccine components
• 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
• Any condition, which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

London, E1 1BB, United Kingdom

Location

Unknown Facility

London, SW17 ORE, United Kingdom

Location

Related Publications (1)

• El Bashir H, Heath PT, Papa T, Ruggeberg JU, Johnson N, Sinha R, Balfour G, Booy R. Antibody responses to meningococcal (groups A, C, Y and W135) polysaccharide diphtheria toxoid conjugate vaccine in children who previously received meningococcal C conjugate vaccine. Vaccine. 2006 Mar 24;24(14):2544-9. doi: 10.1016/j.vaccine.2005.12.018. Epub 2005 Dec 27.

  PMID: 16417952 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Meningitis; Meningococcal Infections

Interventions

Meningococcal Vaccines; Vaccines; Hiberix

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

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

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Monitor

  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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Study Start: August 1, 2003
• Primary Completion: March 1, 2004
• Study Completion: May 1, 2004
• Last Updated: April 14, 2016
• Results First Posted: April 24, 2009

Record last verified: 2016-04

Locations

GB (2)