Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children
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|ClinicalTrials.gov Identifier: NCT00771849|
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : April 24, 2009
Last Update Posted : April 14, 2016
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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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Meningitis Meningococcemia||Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Biological: Haemophilus Influenzae Type b (Hib) vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||March 2004|
|Actual Study Completion Date :||May 2004|
Experimental: Menactra® Vaccine Group
Participants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®
Active Comparator: Hiberix® Vaccine Group
Participants receiving Haemophilus Influenzae Type b (Hib) vaccine
Biological: Haemophilus Influenzae Type b (Hib) vaccine
0.5 mL, Intramuscular
Other Name: Hiberix®
- Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination. [ Time Frame: Day 0 (before) and 28 days post-vaccination ]
- Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination. [ Time Frame: 28 days post-vaccination ]
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|Ages Eligible for Study:||2 Years to 4 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771849
|London, United Kingdom, E1 1BB|
|London, United Kingdom, SW17 ORE|
|Study Director:||Medical Monitor||Sanofi Pasteur Inc.|
Publications of Results:
|Responsible Party:||Sanofi Pasteur, a Sanofi Company|
|Other Study ID Numbers:||
|First Posted:||October 15, 2008 Key Record Dates|
|Results First Posted:||April 24, 2009|
|Last Update Posted:||April 14, 2016|
|Last Verified:||April 2016|
Nervous System Diseases
Gram-Positive Bacterial Infections
Bacterial Infections and Mycoses