Clinical trial NCT00129116: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Haemophilus Influenzae Type b
Neisseria Meningitidis
Keywords: Invasive bacterial disease caused by Hib
Neisseria meningitidis serogroups C & Y
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-08-11
Enrollment: 388
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Primary \& booster vaccination study to evaluate the immuno,reacto \& safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C \& Y-conjugate vaccine \& one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule

Eligibility 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.

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: Anti-PRP Antibody Concentrations
timeFrame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
measure: 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)
measure: 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)
measure: rSBA-MenC Antibody Titres
timeFrame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
measure: rSBA-MenY Antibody Titres
timeFrame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
measure: 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)
measure: 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)
measure: Anti-PSC Antibody Concentrations
timeFrame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
measure: Anti-PSY Antibody Concentrations
timeFrame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
measure: 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)
measure: Anti-T Antibody Concentrations
timeFrame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
measure: Anti-diphtheria Antibody Concentrations
timeFrame: One month after the third dose (at study Month 3 - primary phase)
measure: Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
timeFrame: One month after the third dose (at study Month 3 - primary phase)
measure: Anti-poliovirus Types 1, 2, 3 Antibody Titres
timeFrame: One month after the third dose (at study Month 3 - primary phase)
measure: Number of Seroprotected Subjects for Anti-diphtheria Antibodies
timeFrame: One month after the third dose (at study Month 3 - primary phase)
measure: Number of Seroprotected Subjects for Anti-hepatitis B Antibodies
timeFrame: One month after the third dose (at study Month 3 - primary phase)
measure: 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)
measure: Number of Subjects With Vaccine Response to PT, FHA and PRN
timeFrame: One month after the third dose (at study Month 3 - primary phase)
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 8-day (Day 0-7) follow-up period (during the primary phase)
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 8-day (Day 0-7) follow-up period (during the primary phase)
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Day 0-30) follow-up period (during the primary phase)
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: Over the full course of the primary phase (up to study Month 3 - primary phase)
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 8-day (Day 0-7) follow-up period (during the booster phase)
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 8-day (Day 0-7) follow-up period (during the booster phase)
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Day 0-30) follow-up period (during the booster phase)
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: Over the full course of the booster phase (up to study Month 1 - booster phase)
Other outcomes:
Locations:
city: Asse
country: Belgium
facility: GSK Investigational Site
city: Drongen
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Maldegem
country: Belgium
facility: GSK Investigational Site
city: Merelbeke
country: Belgium
facility: GSK Investigational Site
city: Oudenaarde
country: Belgium
facility: GSK Investigational Site
city: Sint-Amandsberg
country: Belgium
facility: GSK Investigational Site
city: Cham
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kaufering
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Noerdlingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Olching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Niedernhausen
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Detmold
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kirchlengern
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Loehne
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Bredstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
citation: Habermehl P, Leroux-Roels G, Sanger R, Machler G, Boutriau D. 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. Hum Vaccin. 2010 Aug;6(8):640-51. doi: 10.4161/hv.6.8.12154.