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

Meningitis Clinical Trial

Official title:

Antibody Responses for Serogroup C After One Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine Versus a Non-meningococcal Control Vaccine in Children Who Have Previously Received a Monovalent Meningococcal C Conjugate Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771849
• Other study ID #: MTA15
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2008
• Last updated: April 12, 2016
• Start date: August 2003
• Est. completion date: May 2004

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 4 Years

Eligibility

Inclusion Criteria :

• 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.

Exclusion Criteria :

• Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, etc.)

• Known or suspected impairment of immunologic function

• Acute medical illness with or without fever within the last 72 hours or an axillary temperature = 37.5ºC at the time of inclusion

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Meningococcemia

Intervention

Biological:
• Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
• Haemophilus Influenzae Type b (Hib) vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United Kingdom, 

References & 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 conjug — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

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