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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00127855




Registration number
NCT00127855
Ethics application status
Date submitted
8/08/2005
Date registered
9/08/2005

Titles & IDs
Public title
Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine
Scientific title
A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity (Including Immune Memory), Reactogenicity and Safety of Three Different Formulations of the GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups CY Conjugate Vaccine Given Concomitantly With Infanrix® Penta and Prevenar®, Versus ActHIB® and Meningitec® Given Concomitantly With Infanrix® Penta and Versus ActHIB® Given Concomitantly With Infanrix® Penta and Prevenar® in Infants According to a 2-4-6 Month Schedule.
Secondary ID [1] 0 0
792014/002
Secondary ID [2] 0 0
792014/001
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
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
Treatment: Other - Hib-MenCY-TT vaccine (MenHibrix)
Treatment: Other - Meningitec®
Treatment: Other - ActHIB®
Treatment: Other - Infanrix® Penta
Treatment: Other - Prevenar®
Treatment: Other - Mencevax® ACWY
Treatment: Other - PRP (Polyribosyl Ribitol Phosphate)

Experimental: MenHibrix Formulation 1 Group - Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Experimental: MenHibrix Formulation 2 Group - Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Experimental: MenHibrix Formulation 3 Group - Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Active comparator: Menjugate Group - Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Active comparator: ActHIB Group - Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.


Treatment: Other: Hib-MenCY-TT vaccine (MenHibrix)
Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively

Treatment: Other: Meningitec®
Three doses were administered IM in right lower thigh at Months 0,2 and 4.

Treatment: Other: ActHIB®
Three doses were administered IM in left thigh at Months 0,2 and 4.

Treatment: Other: Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.

Treatment: Other: Prevenar®
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.

Treatment: Other: Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.

Treatment: Other: PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
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) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter
Timepoint [1] 0 0
One month after primary vaccination (Month 5)
Primary outcome [2] 0 0
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8
Timepoint [2] 0 0
One month after primary vaccination (Month 5)
Primary outcome [3] 0 0
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8
Timepoint [3] 0 0
One month after primary vaccination (Month 5)
Secondary outcome [1] 0 0
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8
Timepoint [1] 0 0
Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Secondary outcome [2] 0 0
Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers
Timepoint [2] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Secondary outcome [3] 0 0
Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8
Timepoint [3] 0 0
Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Secondary outcome [4] 0 0
Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers
Timepoint [4] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Secondary outcome [5] 0 0
Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
Timepoint [5] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Secondary outcome [6] 0 0
Anti-polysaccharide C (PSC) Antibody Concentration
Timepoint [6] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Secondary outcome [7] 0 0
Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
Timepoint [7] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Secondary outcome [8] 0 0
Anti-polysaccharide Y (PSY) Antibody Concentration
Timepoint [8] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Secondary outcome [9] 0 0
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Timepoint [9] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Secondary outcome [10] 0 0
Anti-PRP Antibody Concentration
Timepoint [10] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Secondary outcome [11] 0 0
Number of Subjects Seroprotected for Anti-diphtheria Antibodies
Timepoint [11] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [12] 0 0
Anti-diphtheria Antibody Concentrations
Timepoint [12] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [13] 0 0
Number of Subjects Seroprotected for Anti-tetanus Antibodies
Timepoint [13] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [14] 0 0
Anti-tetanus Antibody Concentrations
Timepoint [14] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [15] 0 0
Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies
Timepoint [15] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [16] 0 0
Anti- FHA Antibody Concentrations
Timepoint [16] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [17] 0 0
Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies
Timepoint [17] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [18] 0 0
Anti-PRN Antibody Concentrations
Timepoint [18] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [19] 0 0
Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies
Timepoint [19] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [20] 0 0
Anti- PT Antibody Concentrations
Timepoint [20] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [21] 0 0
Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies
Timepoint [21] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [22] 0 0
Anti- HBs Antibody Concentrations
Timepoint [22] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [23] 0 0
Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies
Timepoint [23] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [24] 0 0
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Timepoint [24] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [25] 0 0
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Timepoint [25] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [26] 0 0
Anti-pneumococcal Antibody Concentrations
Timepoint [26] 0 0
Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Secondary outcome [27] 0 0
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course
Timepoint [27] 0 0
During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course
Secondary outcome [28] 0 0
Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose
Timepoint [28] 0 0
During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose
Secondary outcome [29] 0 0
Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course
Timepoint [29] 0 0
During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course
Secondary outcome [30] 0 0
Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose
Timepoint [30] 0 0
During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose
Secondary outcome [31] 0 0
Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course
Timepoint [31] 0 0
Up to one month after the 3-dose primary vaccination course (Month 5)
Secondary outcome [32] 0 0
Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose
Timepoint [32] 0 0
Up to one month following administration of the polysaccharide challenge dose (Month 11)

Eligibility
Key inclusion criteria
Inclusion criteria:

* A male or female between, and including, 6 and 12 weeks (42-90 days) 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.
* Vaccinated against hepatitis B at birth.
* Born after a gestation period of 36 - 42 weeks.
Minimum age
6 Weeks
Maximum age
12 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:

* Use of any investigational or non-registered 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 of immunosuppressants or other immune-modifying drugs since birth
* Any chronic drug therapy to be continued during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine(s).
* Previous vaccination against diphtheria, tetanus, pertussis, polio, N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
* History of or known exposure to diphtheria, tetanus, pertussis, polio, or invasive diseases due to N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* 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.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
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
1/03/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/02/2004
Sample size
Target
Accrual to date
Final
409
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 - Subiaco
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
6018 - Subiaco

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/NCT00127855