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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00134719




Registration number
NCT00134719
Ethics application status
Date submitted
10/08/2005
Date registered
25/08/2005

Titles & IDs
Public title
Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines
Scientific title
A Multicentre Primary & Booster Vaccination Study of GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine When Given According to the 2-4-6 Month Schedule to Healthy Infants With Booster Dose at 12 to 15 Months
Secondary ID [1] 0 0
102371
Secondary ID [2] 0 0
102370 (primary study)
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MenHibrix (Hib-MenCY-TT)
Treatment: Other - Infanrix® Penta
Treatment: Other - Prevenar®
Treatment: Other - ActHIB®
Treatment: Other - Meningitec®
Treatment: Other - M-M-R®II
Treatment: Other - Varivax®
Treatment: Other - PedvaxHIB®

Experimental: MenHibrix Group - Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.

Active comparator: ActHIB + Meningitec Group - Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.

Active comparator: ActHIB/PedvaxHIB Group - Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.


Treatment: Other: MenHibrix (Hib-MenCY-TT)
One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B)

Treatment: Other: Infanrix® Penta
One intramuscular dose at 2, 4 and 6 months of age

Treatment: Other: Prevenar®
One intramuscular dose at 2, 4 and 6 months of age

Treatment: Other: ActHIB®
One intramuscular dose at 2, 4 and 6 months of age

Treatment: Other: Meningitec®
One intramuscular dose at 2, 4 and 6 months of age

Treatment: Other: M-M-R®II
One subcutaneous dose at 12-15 months of age

Treatment: Other: Varivax®
One subcutaneous dose at 12 to 15 months of age

Treatment: Other: PedvaxHIB®
One intramuscular dose at 12 to 15 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-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL)
Timepoint [1] 0 0
One month after the 3-dose primary vaccination course
Primary outcome [2] 0 0
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128
Timepoint [2] 0 0
One month after the 3-dose primary vaccination course
Primary outcome [3] 0 0
Number of Subjects Seroconverted for Anti-measles Antibodies
Timepoint [3] 0 0
42 days after the fourth dose vaccination
Primary outcome [4] 0 0
Number of Subjects Seroconverted for Anti-mumps Antibodies
Timepoint [4] 0 0
42 days after the fourth dose vaccination
Primary outcome [5] 0 0
Number of Subjects With an Anti-rubella Seroresponse
Timepoint [5] 0 0
42 days after the fourth dose vaccination
Primary outcome [6] 0 0
Number of Subjects Seroconverted for Anti-varicella Antibodies
Timepoint [6] 0 0
42 days after the fourth dose vaccination
Secondary outcome [1] 0 0
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values
Timepoint [1] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [2] 0 0
rSBA-MenC Titers
Timepoint [2] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [3] 0 0
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values
Timepoint [3] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [4] 0 0
rSBA-MenY Titers
Timepoint [4] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [5] 0 0
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values
Timepoint [5] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [6] 0 0
hSBA-MenC Titers
Timepoint [6] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [7] 0 0
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values
Timepoint [7] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [8] 0 0
hSBA-MenY Titers
Timepoint [8] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [9] 0 0
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Timepoint [9] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [10] 0 0
Anti-PSC Concentrations
Timepoint [10] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [11] 0 0
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Timepoint [11] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [12] 0 0
Anti-PSY Concentrations
Timepoint [12] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [13] 0 0
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Timepoint [13] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [14] 0 0
Anti-PRP Concentrations
Timepoint [14] 0 0
After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Secondary outcome [15] 0 0
Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL
Timepoint [15] 0 0
Just prior to the fourth dose and 42 days after the fourth dose
Secondary outcome [16] 0 0
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50
Timepoint [16] 0 0
Just prior to the fourth dose and 42 days after the fourth dose
Secondary outcome [17] 0 0
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL
Timepoint [17] 0 0
Just prior to the fourth dose and 42 days after the fourth dose
Secondary outcome [18] 0 0
Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5
Timepoint [18] 0 0
Just prior to the fourth dose and 42 days after the fourth dose
Secondary outcome [19] 0 0
Number of Subjects With a Fourth Dose Response for hSBA-MenC
Timepoint [19] 0 0
42 days after the fourth dose
Secondary outcome [20] 0 0
Number of Subjects With a Fourth Dose Response for hSBA-MenY
Timepoint [20] 0 0
42 days after the fourth dose
Secondary outcome [21] 0 0
Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
Timepoint [21] 0 0
42 days after the fourth dose
Secondary outcome [22] 0 0
Anti-measles Concentrations in Initially Seronegative Subjects
Timepoint [22] 0 0
42 days after the fourth dose
Secondary outcome [23] 0 0
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
Timepoint [23] 0 0
42 days after the fourth dose
Secondary outcome [24] 0 0
Anti-rubella Concentrations in Initially Seronegative Subjects
Timepoint [24] 0 0
42 days after the fourth dose
Secondary outcome [25] 0 0
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination
Timepoint [25] 0 0
42 days after the fourth dose
Secondary outcome [26] 0 0
Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
Timepoint [26] 0 0
42 days after the fourth dose
Secondary outcome [27] 0 0
Anti-mumps Titers in Initially Seronegative Subjects
Timepoint [27] 0 0
42 days after the fourth dose
Secondary outcome [28] 0 0
Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
Timepoint [28] 0 0
42 days after the fourth dose
Secondary outcome [29] 0 0
Anti-varicella Titers in Initially Seronegative Subjects
Timepoint [29] 0 0
42 days after the fourth dose
Secondary outcome [30] 0 0
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase
Timepoint [30] 0 0
During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase
Secondary outcome [31] 0 0
Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase
Timepoint [31] 0 0
During a 4-day period (Day 0-3) after the fourth dose vaccination phase
Secondary outcome [32] 0 0
Number of Subjects Reporting Unsolicited Adverse Events
Timepoint [32] 0 0
During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period
Secondary outcome [33] 0 0
Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine
Timepoint [33] 0 0
During a 43-day (Day 0-42) after the fourth dose
Secondary outcome [34] 0 0
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase
Timepoint [34] 0 0
From enrolment through the day preceding the fourth dose
Secondary outcome [35] 0 0
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase
Timepoint [35] 0 0
From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age

Eligibility
Key inclusion criteria
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 6 and 12 weeks of age at the time of the first 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.
* Born after a gestation period between 36 and 42 weeks.
Minimum age
6 Weeks
Maximum age
12 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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) of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
* Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine. Vaccination with hepatitis B at birth is accepted (although not mandatory). Influenza vaccination is allowed 30 days after administration of the third vaccine dose to 30 days preceding the booster dose.
* History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, Streptococcus pneumoniae and/or varicella invasive disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber, tetanus toxoid, diphtheria toxoid, neomycin, polymyxin.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* 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 specific criteria for the booster part of the study
* History of or previous vaccination against measles, mumps, rubella or varicella.
* Previous booster vaccination with Hib or meningococcal serogroup C vaccine since the last visit of the primary phase.

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 2
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
11/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/02/2007
Sample size
Target
Accrual to date
Final
1104
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - North Adelaide
Recruitment hospital [2] 0 0
GSK Investigational Site - Carlton
Recruitment hospital [3] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
- Perth

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT00134719