Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00631995




Registration number
NCT00631995
Ethics application status
Date submitted
29/02/2008
Date registered
10/03/2008
Date last updated
6/02/2018

Titles & IDs
Public title
Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers
Scientific title
Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in Toddlers
Secondary ID [1] 0 0
MET32
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meningitis 0 0
Meningococcal Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Meningococcal Polysaccharide Tetanus Protein Conjugate
Treatment: Other - Meningococcal Polysaccharide Tetanus Protein Conjugate
Treatment: Other - Meningococcal Polysaccharide Tetanus Protein Conjugate
Treatment: Other - Meningococcal Polysaccharide Tetanus Protein Conjugate
Treatment: Other - Meningococcal Polysaccharide Tetanus Protein Conjugate
Treatment: Other - Meningococcal polysaccharide group C conjugated

Experimental: Group 1 -

Experimental: Group 2 -

Experimental: Group 3 -

Experimental: Group 4 -

Experimental: Group 5 -

Active comparator: Group 6 -


Treatment: Other: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular

Treatment: Other: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular

Treatment: Other: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular

Treatment: Other: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular

Treatment: Other: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular

Treatment: Other: Meningococcal polysaccharide group C conjugated
0.5 mL, Intramuscular
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To provide information concerning the safety and immunogenicity after administration of TetraMenT
Timepoint [1] 0 0
30 days after each injection

Eligibility
Key inclusion criteria
Inclusion Criteria :

* Subject is healthy, as determined by medical history and physical assessment.
* Aged 12 months (± 21 days) on the day of inclusion.
* Institutional Review Board (IRB)-approved informed consent form signed by the subject's parent/legal guardian.
* Able to attend all scheduled visits and to comply with all trial procedures.
Minimum age
12 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria :

* Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, or autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion.
* Known or suspected impairment of immunologic function.
* Acute medical illness within the last 72 hours, or temperature = 37.5ºC (axillary) at the time of enrollment (temporary contraindication).
* History of documented invasive meningococcal disease or previous meningococcal vaccination.
* Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian.
* 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 two weeks prior to enrollment. Topical steroids are not included in this exclusion criterion.
* Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops are not included in this exclusion criterion.
* Suspected or known hypersensitivity to any of the vaccine components.
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination.
* Parent or legal guardian unable or unwilling to comply with the stu dy procedures.
* Participation in another interventional clinical trial in the 30 days preceding enrollment, or participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period.
* Diagnosed with any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
* Received any vaccine in the 30-day period prior to receipt of study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of any study vaccine. Hyposensitization therapy and influenza vaccination may be received up to 14 days before or 14 days after receiving the study vaccines.
* History of seizures, including febrile seizures, or any other neurologic disorder.
* Personal or family history of Guillain-Barré Syndrome (GBS).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
360
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Herston
Recruitment hospital [2] 0 0
- Melbourne
Recruitment hospital [3] 0 0
- North Adelaide
Recruitment hospital [4] 0 0
- Perth
Recruitment hospital [5] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- North Adelaide
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment postcode(s) [5] 0 0
- Westmead

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.

Primary Objectives: Safety and Immunogenicity:

To describe the safety and immunogenicity profiles of:

* A single dose of each formulation of TetraMen-T vaccine
* A single dose of NeisVac-C® vaccine.
Trial website
https://clinicaltrials.gov/study/NCT00631995
Trial related presentations / publications
McVernon J, Nolan T, Richmond P, Reynolds G, Nissen M, Lambert SB, Marshall H, Papa T, Rehm C. A randomized trial to assess safety and immunogenicity of alternative formulations of a quadrivalent meningococcal (A, C, Y, and W-135) tetanus protein conjugate vaccine in toddlers. Pediatr Infect Dis J. 2012 Jan;31(1):e15-23. doi: 10.1097/INF.0b013e31823e1e34.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Sanofi Pasteur Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00631995