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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)
Assessment method [1] 0 0
The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.
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
Assessment method [2] 0 0
The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.
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
Assessment method [3] 0 0
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination.
Timepoint [3] 0 0
42 days after the fourth dose vaccination
Primary outcome [4] 0 0
Number of Subjects Seroconverted for Anti-mumps Antibodies
Assessment method [4] 0 0
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (\<28 ED50) before vaccination. ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
Timepoint [4] 0 0
42 days after the fourth dose vaccination
Primary outcome [5] 0 0
Number of Subjects With an Anti-rubella Seroresponse
Assessment method [5] 0 0
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination.
Timepoint [5] 0 0
42 days after the fourth dose vaccination
Primary outcome [6] 0 0
Number of Subjects Seroconverted for Anti-varicella Antibodies
Assessment method [6] 0 0
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination.
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
Assessment method [1] 0 0
The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.
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
Assessment method [2] 0 0
The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean 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
Assessment method [3] 0 0
The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.
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
Assessment method [4] 0 0
The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean 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
Assessment method [5] 0 0
The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.
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
Assessment method [6] 0 0
The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean 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
Assessment method [7] 0 0
The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.
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
Assessment method [8] 0 0
The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean 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
Assessment method [9] 0 0
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.
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
Assessment method [10] 0 0
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean 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
Assessment method [11] 0 0
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.
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
Assessment method [12] 0 0
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean 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
Assessment method [13] 0 0
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.15 µg/mL and 1.0 µg/mL.
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
Assessment method [14] 0 0
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean 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
Assessment method [15] 0 0
The cut-off value assessed was 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
Assessment method [16] 0 0
ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
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
Assessment method [17] 0 0
The cut-off value assessed was 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
Assessment method [18] 0 0
The cut-off value assessed was a titer of 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
Assessment method [19] 0 0
Fourth dose response for hSBA-MenC is defined as: •For initially seronegative subjects (i.e., subjects with pre fourth dose hSBA antibody titer below 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:16; •For initially seropositive subjects (i.e., subjects with pre fourth dose antibody titer greater than or equal to 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:128.
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
Assessment method [20] 0 0
Fourth dose response for hSBA-MenY defined as: •For initially seronegative subjects (i.e., pre fourth dose hSBA antibody titer \< 1:4), post fourth dose hSBA antibody titer greater than or equal to (=) 1:16; •For initially seropositive subjects with pre fourth dose hSBA antibody titer = 1:4 and \< 1:64, post fourth dose hSBA antibody titer at least 4-fold higher than the pre fourth dose hSBA antibody titer; •For initially seropositive subjects with pre fourth dose hSBA antibody titer = 1:64, post fourth dose hSBA antibody titer at least 2-fold higher than the pre fourth dose hSBA antibody titer.
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
Assessment method [21] 0 0
The pre-defined cut-off values were 150 mIU/mL and 200 mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.
Timepoint [21] 0 0
42 days after the fourth dose
Secondary outcome [22] 0 0
Anti-measles Concentrations in Initially Seronegative Subjects
Assessment method [22] 0 0
Concentrations are presented as Geometric Mean Concentrations expressed as mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.
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
Assessment method [23] 0 0
The pre-defined cut-off values were 4 IU/mL and 10 IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 4 IU/mL.
Timepoint [23] 0 0
42 days after the fourth dose
Secondary outcome [24] 0 0
Anti-rubella Concentrations in Initially Seronegative Subjects
Assessment method [24] 0 0
Concentrations are presented as Geometric Mean Concentrations expressed as IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-rubella concentration below 4 IU/mL.
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
Assessment method [25] 0 0
ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
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
Assessment method [26] 0 0
The pre-defined cut-off values were 28 ED50 and 51 ED50. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.
Timepoint [26] 0 0
42 days after the fourth dose
Secondary outcome [27] 0 0
Anti-mumps Titers in Initially Seronegative Subjects
Assessment method [27] 0 0
Titers are presented as Geometric Mean Titers expressed as ED50, the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.
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
Assessment method [28] 0 0
The pre-defined cut-off values were 1:5 and 1:40. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.
Timepoint [28] 0 0
42 days after the fourth dose
Secondary outcome [29] 0 0
Anti-varicella Titers in Initially Seronegative Subjects
Assessment method [29] 0 0
Titers are presented as Geometric Mean Titers. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.
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
Assessment method [30] 0 0
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.
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
Assessment method [31] 0 0
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.
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
Assessment method [32] 0 0
Unsolicited adverse event covers any adverse event 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.
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
Assessment method [33] 0 0
Specific solicited general symptoms assessed include fever (temperature greater than or equal to 38 degrees Celcius), meningismus/ febrile convulsion, parotid / salivary gland swelling and rash.
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
Assessment method [34] 0 0
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.
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
Assessment method [35] 0 0
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.
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
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


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