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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01777308




Registration number
NCT01777308
Ethics application status
Date submitted
24/01/2013
Date registered
28/01/2013
Date last updated
25/01/2019

Titles & IDs
Public title
Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination
Scientific title
The Vaccine Response and Long-term Antibody Persistence of GSK Biologicals' MenACWY-TT Vaccine (GSK134612) Administered as One Dose at 6 Years Post-MenC Primary Vaccination in Healthy Subjects Aged 12-18 Months at Primary Vaccination
Secondary ID [1] 0 0
2012-002575-34
Secondary ID [2] 0 0
116727
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infections, Meningococcal 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Meningococcal conjugate vaccine GSK134612

Experimental: Menitorix Group - Subjects who were primed with Menitorix™ (Hib-MenC-TT) + Priorix™ (MMR) vaccines in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1).

The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Experimental: Meningitec + Hiberix Group - Subjects who were primed with Meningitec™ (MCC) + Hiberix™ (Hib) + Priorix™ (MMR) vaccine in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1).

The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.


Treatment: Other: Meningococcal conjugate vaccine GSK134612
Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)
Timepoint [1] 0 0
At Month 73, one month post-booster vaccination
Secondary outcome [1] 0 0
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers = the Predefined Cut-off Values
Timepoint [1] 0 0
At Month 73, one month post-booster vaccination
Secondary outcome [2] 0 0
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
Timepoint [2] 0 0
At Month 73, one month post-booster vaccination
Secondary outcome [3] 0 0
Number of Subjects With Anti-tetanus (Anti-T) Concentrations = the Predefined Cut-off Values
Timepoint [3] 0 0
At Month 73, one month post-booster vaccination
Secondary outcome [4] 0 0
Antibody Concentrations Against Tetanus (Anti-T) Antigen
Timepoint [4] 0 0
At Month 73, one month post-booster vaccination
Secondary outcome [5] 0 0
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers = the Predefined Cut-off Values
Timepoint [5] 0 0
At Month 96, 24 months post-booster vaccination
Secondary outcome [6] 0 0
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY
Timepoint [6] 0 0
At Month 96, 24 months post-booster vaccination
Secondary outcome [7] 0 0
Number of Subjects With Any Solicited Local Symptoms
Timepoint [7] 0 0
During the 4-day (Days 0-3) post-booster vaccination period at Month 72
Secondary outcome [8] 0 0
Number of Subjects With Any Solicited General Symptoms
Timepoint [8] 0 0
During the 4-day (Days 0-3) post-booster vaccination period at Month 72
Secondary outcome [9] 0 0
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
Timepoint [9] 0 0
During the 31-day (Days 0-30) post-booster vaccination period at Month 72
Secondary outcome [10] 0 0
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Timepoint [10] 0 0
During the 31-day (Days 0-30) post-booster vaccination period at Month 72
Secondary outcome [11] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [11] 0 0
During the 31-day (Days 0-30) post-booster vaccination period at Month 72
Secondary outcome [12] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [12] 0 0
From Month 72 up to study end, at Month 96

Eligibility
Key inclusion criteria
* Subjects' parent(s)/Legally Acceptable Representative(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
* A male or female between, and including, 84 and 95 months of age at the time of the booster vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject in accordance with local laws and regulations.
* Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
* Having completed the vaccination in the study [Hib-MenC-TT-016 (106445)] as per protocol.
Minimum age
84 Months
Maximum age
95 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Child in care.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
* Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
* Previous vaccination with meningococcal vaccine except the meningococcal vaccination received in the Hib-MenC-TT-016 study.
* History of meningococcal disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV)infection, based on medical history and physical examination (no laboratory testing required).
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s).
* Major congenital defects or serious chronic illness.
* History of any neurological disorders or seizures, including GBS. History of a simple, single febrile seizure is permitted.
* Acute disease and/or fever at the time of enrollment.

* Fever is defined as temperature = 37.5°C for oral, axillary or tympanic route, or = 38.0°C for rectal route. The preferred route for recording temperature in this study will be oral.
* Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccination or planned administration during the booster vaccination phase of the study (i.e. between Visit 1 and Visit 2) and within 3 months preceding the blood sampling at Visit 3.

The following criteria should be checked for the long-term persistence phase at two years after booster vaccination (Visit 3):

In case an exclusion criterion becomes applicable, the subject will not enter the long-term follow-up and the reason will be documented.

* Previous administration of a meningococcal vaccine with the exception of the meningococcal vaccination given in the primary study and the booster vaccination in this particular study.
* History of meningococcal disease.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
3/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/04/2016
Sample size
Target
Accrual to date
Final
156
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [3] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [4] 0 0
GSK Investigational Site - Herston
Recruitment hospital [5] 0 0
GSK Investigational Site - Sherwood
Recruitment hospital [6] 0 0
GSK Investigational Site - North Adelaide
Recruitment hospital [7] 0 0
GSK Investigational Site - Carlton
Recruitment hospital [8] 0 0
GSK Investigational Site - Subiaco
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4075 - Sherwood
Recruitment postcode(s) [6] 0 0
5006 - North Adelaide
Recruitment postcode(s) [7] 0 0
3053 - Carlton
Recruitment postcode(s) [8] 0 0
6008 - Subiaco

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 years after MenACWY-TT booster vaccination.

This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).
Trial website
https://clinicaltrials.gov/study/NCT01777308
Trial related presentations / publications
Nolan T, Booy R, Marshall HS, Richmond P, Nissen M, Ziegler JB, Baine Y, Traskine M, Jastorff A, Van der Wielen M. Immunogenicity and Safety of a Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine 6 Years After MenC Priming as Toddlers. Pediatr Infect Dis J. 2019 Jun;38(6):643-650. doi: 10.1097/INF.0000000000002334.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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/NCT01777308