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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00326118




Registration number
NCT00326118
Ethics application status
Date submitted
12/05/2006
Date registered
16/05/2006
Date last updated
24/08/2018

Titles & IDs
Public title
Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
Scientific title
Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC With Priorix™, Versus MenC-CRM197 Vaccine With Hiberix™ & Priorix™ in Toddlers Primed With Hib But Not MenC & to Evaluate Persistence up to 5 Years After Vaccination.
Secondary ID [1] 0 0
106446
Secondary ID [2] 0 0
106445
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemophilus Influenzae Type b 0 0
Neisseria Meningitidis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Haemophilus influenzae type b and meningococcal serogroup C (vaccine)
Treatment: Other - Priorix™
Treatment: Other - Hiberix™
Treatment: Other - Meningitec™

Active comparator: Meningitec + Hiberix Group - Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Experimental: Menitorix Group - Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.


Treatment: Other: Haemophilus influenzae type b and meningococcal serogroup C (vaccine)
One intramuscular dose at 12-18 months of age

Treatment: Other: Priorix™
One subcutaneous dose at 12-18 months of age

Treatment: Other: Hiberix™
One intramuscular dose at 12-18 months of age.

Treatment: Other: Meningitec™
One intramuscular dose at 12-18 months of age
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)
Timepoint [1] 0 0
1 month after vaccination
Primary outcome [2] 0 0
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer
Timepoint [2] 0 0
1 month after vaccination
Secondary outcome [1] 0 0
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
Timepoint [1] 0 0
Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
Secondary outcome [2] 0 0
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
Timepoint [2] 0 0
5 years after vaccination
Secondary outcome [3] 0 0
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
Timepoint [3] 0 0
Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.
Secondary outcome [4] 0 0
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
Timepoint [4] 0 0
5 years after vaccination
Secondary outcome [5] 0 0
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
Timepoint [5] 0 0
Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
Secondary outcome [6] 0 0
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
Timepoint [6] 0 0
5 years after vaccination
Secondary outcome [7] 0 0
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Timepoint [7] 0 0
Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination
Secondary outcome [8] 0 0
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Timepoint [8] 0 0
5 years after vaccination
Secondary outcome [9] 0 0
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
Timepoint [9] 0 0
Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Secondary outcome [10] 0 0
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
Timepoint [10] 0 0
Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Secondary outcome [11] 0 0
Number of Subjects Reporting Solicited Local and General Symptoms
Timepoint [11] 0 0
Within 4 days (Day 0 -Day 3) after vaccination
Secondary outcome [12] 0 0
Number of Subjects Reporting Unsolicited Symptoms
Timepoint [12] 0 0
Within 31 days (Day 0 - Day 30) after vaccination
Secondary outcome [13] 0 0
Number of Subjects Reporting Serious Adverse Events (SAEs)
Timepoint [13] 0 0
Throughout the entire study period (up to year 5)

Eligibility
Key inclusion criteria
Primary phase:

* Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* A male or female between, and including, 12 and 18 months of age at the time of vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Previously completed routine childhood vaccinations to the best of his/her parents'/guardians knowledge.
* Having completed primary vaccination with two doses of Haemophilus influenzae type b outer membrane protein (Hib-OMP) containing vaccine OR three doses of diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b (DTPa/Hib) containing vaccine at least 6 months before the study start.

Long-term persistence phase:

- Having participated in the vaccination study 106445
Minimum age
12 Months
Maximum age
18 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For the primary vaccination phase:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination.
* Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before vaccination and ending 30 days after vaccination.
* Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose.
* Previous administration of a booster dose of Hib vaccine.
* Previous vaccination against measles, mumps, rubella.
* History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases.
* Known exposure to measles, mumps or rubella within 30 days prior to the start of the study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of neurological disorders or more than one episode of febrile convulsion.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Additional exclusion criteria for the long-term persistence phase: to be checked each year.

* Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines.
* History of H. influenzae type b, meningococcal serogroup C diseases.

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
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
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/11/2007
Sample size
Target
Accrual to date
Final
433
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 - North Adelaide
Recruitment hospital [6] 0 0
GSK Investigational Site - Carlton
Recruitment hospital [7] 0 0
GSK Investigational Site - Perth
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
5006 - North Adelaide
Recruitment postcode(s) [6] 0 0
3053 - Carlton
Recruitment postcode(s) [7] 0 0
- Perth

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year of life to subjects primed in infancy with a Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available Hib and MenC vaccines.

In the extension phase, at Years 1, 2, 3, 4 \& 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Trial website
https://clinicaltrials.gov/study/NCT00326118
Trial related presentations / publications
Booy R, Richmond P, Nolan T, McVernon J, Marshall H, Nissen M, Reynolds G, Ziegler JB, Heron L, Lambert S, Caubet M, Mesaros N, Boutriau D. Immediate and longer term immunogenicity of a single dose of the combined haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in primed toddlers 12 to 18 months of age. Pediatr Infect Dis J. 2011 Apr;30(4):340-2. doi: 10.1097/INF.0b013e31820013d2.
Booy R, Richmond P, Nolan T, McVernon J, Marshall H, Nissen M, Reynolds G, Ziegler JB, Stoney T, Heron L, Lambert S, Mesaros N, Peddiraju K, Miller JM. Three-year antibody persistence and safety after a single dose of combined haemophilus influenzae type b (Hib)-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in Hib-primed toddlers. Pediatr Infect Dis J. 2013 Feb;32(2):169-74. doi: 10.1097/INF.0b013e3182787bff.
Booy R et al. Immunogenicity and safety of the Hib-MenC-TT conjugate vaccine in Hib-primed toddlers: 3 year follow-up. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.
Booy R et al. Immunogenicity and safety of the Hib-MenC-TT conjugate vaccine in Hib-primed toddlers: 4 year follow-up. Abstract presented at the Communicable Diseases Network Australia - Communicable Diseases Control Conference 2013, Canberra, Australia, 19-20 March 2013.
Booy R et al. Prolonged immunogenicity and safety of the HibMenC-TT conjugate vaccine in Hib-Primed toddlers. Abstract presented at the PHAA Communicable Disease Conference. Canberra, Australia, 4-6 April 2011.
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/NCT00326118