Last updated: 11/04/2018 04:14:27

3 formulations of Hib-MenCY-TT vaccine & 1 formulation of Hib-MenC-TT vaccine compared to licensed meningococcal serogroup C conjugate vaccine, each administered at 2,3,4 mths of age

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GSK study ID
792014/003
See study documents
Clinicaltrials.gov ID
NCT00129116
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A phase II, open (partially double-blind), randomised, controlled, multicentre, primary vaccination study to evaluate the immunogenicity, reactogenicity and safety of three different formulations of GSK Biologicals’ combined Haemophilus influenzae type b-meningococcal serogroups C and Y- conjugate vaccine and one formulation of GSK Biologicals’ Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine each given concomitantly with InfanrixTM penta, versus MeningitecTM, given concomitantly with InfanrixTM hexa in infants according to a 2-3-4 month schedule
Trial description: This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration equal to or above 1 microgram per millilitre (µg/mL).

Timeframe: One month after dose 3 (at study Month 3 - primary phase)

Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titre equal to or above 1:8

Timeframe: One month after dose 3 (at study Month 3 - primary phase)

Number of subjects with meningococcal serogroup Y serum bactericidal assay using rabbit complement (rSBA-MenY) titre equal to or above 1:8

Timeframe: One month after dose 3 (at study Month 3 - primary phase)

Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration equal to or above 1 microgram per millilitre (µg/mL).

Timeframe: One month after the booster vaccination (at study Month 1 – booster phase)

Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titre equal to or above 1:8

Timeframe: One month after the booster vaccination (at study Month 1 – booster phase)

Number of subjects with meningococcal serogroup Y serum bactericidal assay using rabbit complement (rSBA-MenY) titre equal to or above 1:8

Timeframe: One month after the booster vaccination (at study Month 1 – booster phase)

Secondary outcomes:

Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titre equal to or above 1:8

Timeframe: Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase)

Number of subjects with meningococcal serogroup Y serum bactericidal assay using rabbit complement (rSBA-MenY) titre equal to or above 1:8

Timeframe: Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase)

Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration equal to or above 1 microgram per millilitre (µg/mL).

Timeframe: Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase)

Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration equal to or above 1 microgram per millilitre (µg/mL).

Timeframe: Prior to the booster vaccination (at study Month 0 – booster phase)

Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titre equal to or above 1:8

Timeframe: Prior to the booster vaccination (at study Month 0 – booster phase)

Number of subjects with meningococcal serogroup Y serum bactericidal assay using rabbit complement (rSBA-MenY) titre equal to or above 1:8

Timeframe: Prior to the booster vaccination (at study Month 0 – booster phase)

rSBA-MenC antibody titres

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)

rSBA-MenY antibody titres

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)

Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration equal to or above 0.15 microgram per millilitre (µg/mL).

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)

Anti-PRP antibody concentrations

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)

Number of subjects with anti-polysaccharide C (anti-PSC) antibody concentration equal to or above 0.30 microgram per millilitre (µg/mL)

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)

Number of subjects with anti-polysaccharide Y (anti-PSY) antibody concentration equal to or above 0.30 microgram per millilitre (µg/mL)

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)

Anti-PSC antibody concentrations

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)

Anti-PSY antibody concentrations

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)

Anti-tetanus antibody concentrations

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)

Anti-filamentous haemagglutinin (anti-FHA), anti-pertactin (anti-PRN), anti-pertussis toxoid (anti-PT) antibody concentrations

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)

Number of seroprotected subjects for anti-tetanus antibodies

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)

Number of subjects with anti-FHA, anti-PRN and anti-PT antibody concentration equal to or above 5 Enzyme-Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL)

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)

Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration equal to or above 0.15 microgram per millilitre (µg/mL).

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)

Anti-PRP antibody concentrations

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)

Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titre equal to or above 1:128

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)

Number of subjects with meningococcal serogroup Y serum bactericidal assay using rabbit complement (rSBA-MenY) titre equal to or above 1:128

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)

rSBA-MenC antibody titres

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)

rSBA-MenY antibody titres

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)

Number of subjects with anti-polysaccharide C (anti-PSC) antibody concentration equal to or above 0.30 microgram per millilitre (µg/mL)

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)

Number of subjects with anti-polysaccharide C (anti-PSC) antibody concentration equal to or above 2.0 microgram per millilitre (µg/mL)

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)

Anti-PSC antibody concentrations

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)

Anti-PSY antibody concentrations

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)

Number of subjects with anti-tetanus toxoid (anti-T) antibody concentration equal to or above 0.1 International units per millilitre (IU/mL).

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)

Anti-T antibody concentrations

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)

Anti-diphtheria antibody concentrations

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Anti-hepatitis B surface antigen (HBs) antibody concentrations

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Anti-poliovirus types 1, 2, 3 antibody titres

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Number of seroprotected subjects for anti-diphtheria antibodies

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Number of seroprotected subjects for anti-hepatitis B antibodies

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Number of seroprotected subjects for anti-poliovirus types 1, 2 and 3 antibodies

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Number of subjects with vaccine response to PT, FHA and PRN

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Number of subjects with solicited local symptoms

Timeframe: During the 8-day (Day 0-7) follow-up period (during the primary phase)

Number of subjects with solicited general symptoms

Timeframe: During the 8-day (Day 0-7) follow-up period (during the primary phase)

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During the 31-day (Day 0-30) follow-up period (during the primary phase)

Number of subjects reporting serious adverse events (SAEs)

Timeframe: Over the full course of the primary phase (up to study Month 3 – primary phase)

Number of subjects with solicited local symptoms

Timeframe: During the 8-day (Day 0-7) follow-up period (during the booster phase)

Number of subjects with solicited general symptoms

Timeframe: During the 8-day (Day 0-7) follow-up period (during the booster phase)

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During the 31-day (Day 0-30) follow-up period (during the booster phase)

Number of subjects reporting serious adverse events (SAEs)

Timeframe: Over the full course of the booster phase (up to study Month 1 – booster phase)

Interventions:
Biological/vaccine: Hib-MenCY-TT vaccine
Biological/vaccine: Hib-MenC-TT vaccine
Biological/vaccine: Menjugate ®
Biological/vaccine: Infanrix penta ®
Biological/vaccine: Infanrix hexa ®
Enrollment:
388
Observational study model:
Not applicable
Primary completion date:
2003-16-12
Time perspective:
Not applicable
Clinical publications:
Bryant KA et al. (2011) Haemophilus influenzae type b–Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines.10(7):941-950.
Habermehl P et al. (2010) Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2, 3, 4 months schedule with a fourth dose at 12-18 months of age. Human Vaccine. 25;6(8),640-651.
Medical condition
Haemophilus influenzae type b, Neisseria Meningitidis
Product
SB792014
Collaborators
Not applicable
Study date(s)
March 2003 to December 2003
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
  • Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth.
  • Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.
Inclusion and exclusion criteria
Inclusion criteria:
  • Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth.
Exclusion criteria:
  • Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Olching, Bayern, Germany, 82140
Status
Study Complete
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Location
GSK Investigational Site
Berlin, Berlin, Germany, 14197
Status
Study Complete
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Location
GSK Investigational Site
Berlin, Berlin, Germany, 13355
Status
Study Complete
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Location
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
Status
Study Complete
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Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80939
Status
Study Complete
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Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
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Location
GSK Investigational Site
Muenchen, Bayern, Germany, 81675
Status
Study Complete
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Location
GSK Investigational Site
Kirchlengern, Nordrhein-Westfalen, Germany, 32278
Status
Study Complete
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Location
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
Status
Study Complete
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Location
GSK Investigational Site
Kaufering, Bayern, Germany, 86916
Status
Study Complete
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Location
GSK Investigational Site
Niedernhausen, Hessen, Germany, 65527
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
Status
Study Complete
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Location
GSK Investigational Site
Merelbeke, Belgium, 9820
Status
Will Be Recruiting
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Location
GSK Investigational Site
Berlin, Berlin, Germany, 12627
Status
Study Complete
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Location
GSK Investigational Site
Oudenaarde, Belgium, 9700
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Cham, Bayern, Germany, 93413
Status
Study Complete
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Location
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
Status
Study Complete
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Location
GSK Investigational Site
Leipzig, Sachsen, Germany, 04178
Status
Study Complete
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Location
GSK Investigational Site
Gent, Belgium, 9000
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22307
Status
Study Complete
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Location
GSK Investigational Site
Sint-Amandsberg, Belgium, 9040
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Asse, Belgium, 1730
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Drongen, Belgium, 9031
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Maldegem, Belgium, 9990
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Berlin, Berlin, Germany, 10315
Status
Study Complete
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Location
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2003-16-12
Actual study completion date
2003-16-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

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