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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Other interventions - 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.


Other interventions: Meningococcal conjugate vaccine GSK134612
Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm

Intervention code [1] 0 0
Other interventions
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) - Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (=) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination = 4 fold the pre-vaccination antibody titer.
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 - The cut-off values for the rSBA titers were greater than or equal to (=) 1:8 and 1:128.
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 - Antibody titers were presented as geometric mean titers (GMTs).
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 - The cut-off values for anti-T concentrations were greater than or equal to (=) 0.1 international units per milliliter (IU/mL) and = 1 IU/mL.
Timepoint [3] 0 0
At Month 73, one month post-booster vaccination
Secondary outcome [4] 0 0
Antibody Concentrations Against Tetanus (Anti-T) Antigen - Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
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 - The cut-off values for the rSBA titers were greater than or equal to (=) 1:8 and 1:128.
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 - Antibody titers were presented as geometric mean titers (GMTs).
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 - Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
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 - Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, and fever [defined as oral temperature equal to or above (=) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
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) - NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
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) - An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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) - SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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) - SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/NCT01777308
Trial related presentations / publications
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
Other publications