Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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/NCT00326118
Registration number
NCT00326118
Ethics application status
Date submitted
12/05/2006
Date registered
16/05/2006
Titles & IDs
Public title
Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
Query!
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.
Query!
Secondary ID [1]
0
0
106446
Query!
Secondary ID [2]
0
0
106445
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Haemophilus Influenzae Type b
0
0
Query!
Neisseria Meningitidis
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
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)
Query!
Assessment method [1]
0
0
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
Query!
Timepoint [1]
0
0
1 month after vaccination
Query!
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
Query!
Assessment method [2]
0
0
rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.
Query!
Timepoint [2]
0
0
1 month after vaccination
Query!
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
Query!
Assessment method [1]
0
0
rSBA-MenC titers cut-off values assessed were greater than or equal to (=) 1:8 (indicative of seroprotection) and = 1:128 titers.
Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Query!
Timepoint [1]
0
0
Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
Query!
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
Query!
Assessment method [2]
0
0
rSBA-MenC titers cut-off values assessed were greater than or equal to (=)1:8 (indicative of seroprotection) and 1:128 titers. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Query!
Timepoint [2]
0
0
5 years after vaccination
Query!
Secondary outcome [3]
0
0
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
Query!
Assessment method [3]
0
0
Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Query!
Timepoint [3]
0
0
Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.
Query!
Secondary outcome [4]
0
0
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
Query!
Assessment method [4]
0
0
Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Query!
Timepoint [4]
0
0
5 years after vaccination
Query!
Secondary outcome [5]
0
0
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
Query!
Assessment method [5]
0
0
Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
Query!
Timepoint [5]
0
0
Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
Query!
Secondary outcome [6]
0
0
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
Query!
Assessment method [6]
0
0
Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
Query!
Timepoint [6]
0
0
5 years after vaccination
Query!
Secondary outcome [7]
0
0
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Query!
Assessment method [7]
0
0
Concentrations are given as Geometric Mean Concentrations (GMCs).
Query!
Timepoint [7]
0
0
Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination
Query!
Secondary outcome [8]
0
0
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Query!
Assessment method [8]
0
0
Concentrations are given as Geometric Mean Concentrations (GMCs).
Query!
Timepoint [8]
0
0
5 years after vaccination
Query!
Secondary outcome [9]
0
0
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
Query!
Assessment method [9]
0
0
Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (=) 0.30 µg/mL and = 2.0 µg/mL.
Query!
Timepoint [9]
0
0
Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Query!
Secondary outcome [10]
0
0
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
Query!
Assessment method [10]
0
0
Concentrations given as Geometric Mean Concentrations (GMCs).
Query!
Timepoint [10]
0
0
Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Query!
Secondary outcome [11]
0
0
Number of Subjects Reporting Solicited Local and General Symptoms
Query!
Assessment method [11]
0
0
Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Solicited general symptoms assessed include drowsiness, fever (= 38°C), irritability and loss of appetite.
Query!
Timepoint [11]
0
0
Within 4 days (Day 0 -Day 3) after vaccination
Query!
Secondary outcome [12]
0
0
Number of Subjects Reporting Unsolicited Symptoms
Query!
Assessment method [12]
0
0
Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Query!
Timepoint [12]
0
0
Within 31 days (Day 0 - Day 30) after vaccination
Query!
Secondary outcome [13]
0
0
Number of Subjects Reporting Serious Adverse Events (SAEs)
Query!
Assessment method [13]
0
0
A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually.
Query!
Timepoint [13]
0
0
Throughout the entire study period (up to year 5)
Query!
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
Query!
Minimum age
12
Months
Query!
Query!
Maximum age
18
Months
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
6/11/2007
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
433
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Garran
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Randwick
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Westmead
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Herston
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - North Adelaide
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Carlton
Query!
Recruitment hospital [7]
0
0
GSK Investigational Site - Perth
Query!
Recruitment postcode(s) [1]
0
0
2606 - Garran
Query!
Recruitment postcode(s) [2]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [3]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [4]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [5]
0
0
5006 - North Adelaide
Query!
Recruitment postcode(s) [6]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [7]
0
0
- Perth
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00326118
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00326118