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

Haemophilus Influenzae Type b Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129116
• Other study ID #: 792014/003
• Secondary ID: 100381
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2003
• Est. completion date: December 16, 2003

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: December 16, 2003
• Est. primary completion date: December 1, 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 12 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Haemophilus Influenzae Type b
• Influenza, Human
• Neisseria Meningitidis

Intervention

Biological:
• Hib-MenCY-TT vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
• Hib-MenC-TT vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
• Menjugate ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
• Infanrix penta ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
• Infanrix hexa ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Asse
Belgium	GSK Investigational Site	Drongen
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Maldegem
Belgium	GSK Investigational Site	Merelbeke
Belgium	GSK Investigational Site	Oudenaarde
Belgium	GSK Investigational Site	Sint-Amandsberg
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bredstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Cham	Bayern
Germany	GSK Investigational Site	Detmold	Nordrhein-Westfalen
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Kaufering	Bayern
Germany	GSK Investigational Site	Kirchlengern	Nordrhein-Westfalen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Loehne	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Niedernhausen	Hessen
Germany	GSK Investigational Site	Noerdlingen	Bayern
Germany	GSK Investigational Site	Olching	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Germany, 

References & Publications (2)

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. Review. — View Citation

Habermehl P, Leroux-Roels G, Sänger R, Mächler 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).	Anti-PRP antibody concentration cut-off value assessed was equal to or above (=) 1 microgram per millilitre (µg/mL)	One month after dose 3 (at study Month 3 - primary phase)
Primary	Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8	rSBA-MenC antibody titre cut-off value assessed was =1:8	One month after dose 3 (at study Month 3 - primary phase)
Primary	Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8	rSBA-MenY antibody titre cut-off value assessed was =1:8	One month after dose 3 (at study Month 3 - primary phase)
Primary	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).	Anti-PRP antibody concentration cut-off value assessed was equal to or above (=) 1 microgram per millilitre (µg/mL)	One month after the booster vaccination (at study Month 1 - booster phase)
Primary	Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8	rSBA-MenC antibody titre cut-off value assessed was =1:8	One month after the booster vaccination (at study Month 1 - booster phase)
Primary	Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8	rSBA-MenY antibody titre cut-off value assessed was =1:8	One month after the booster vaccination (at study Month 1 - booster phase)
Secondary	Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8	rSBA-MenC antibody titre cut-off value assessed was =1:8	Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Secondary	Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8	rSBA-MenY antibody titre cut-off value assessed was =1:8	Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Secondary	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).	Anti-PRP antibody concentration cut-off value assessed was equal to or above (=) 1 microgram per millilitre (µg/mL)	Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Secondary	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).	Anti-PRP antibody concentration cut-off value assessed was equal to or above (=) 1 microgram per millilitre (µg/mL)	Prior to the booster vaccination (at study Month 0 - booster phase)
Secondary	Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8	rSBA-MenC antibody titre cut-off value assessed was =1:8	Prior to the booster vaccination (at study Month 0 - booster phase)
Secondary	Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8	rSBA-MenY antibody titre cut-off value assessed was =1:8	Prior to the booster vaccination (at study Month 0 - booster phase)
Secondary	rSBA-MenC Antibody Titres	Titres are expressed as geometric mean titres (GMTs)	Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Secondary	rSBA-MenY Antibody Titres	Titres are expressed as geometric mean titres (GMTs)	Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Secondary	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).	Anti-PRP antibody concentration cut-off value assessed was equal to or above (=) 0.15 microgram per millilitre (µg/mL)	Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Secondary	Anti-PRP Antibody Concentrations	Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.	Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Secondary	Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)	Anti-PSC antibody concentration cut-off value assessed was =0.30 µg/mL	Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Secondary	Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)	Anti-PSY antibody concentration cut-off value assessed was =0.30 µg/mL	Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Secondary	Anti-PSC Antibody Concentrations	Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.	Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Secondary	Anti-PSY Antibody Concentrations	Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.	Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Secondary	Anti-tetanus Antibody Concentrations	Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).	Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Secondary	Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations	Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.	Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Secondary	Number of Seroprotected Subjects for Anti-tetanus Antibodies	Seroprotection status is defined as anti-tetanus toxoid antibody concentration = 0.1 International Units per millilitre (IU/mL)	Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Secondary	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)	Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was = 5 ELISA units per millilitre.	Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Secondary	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).	Anti-PRP antibody concentration cut-off value assessed was equal to or above (=) 0.15 microgram per millilitre (µg/mL)	Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Secondary	Anti-PRP Antibody Concentrations	Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.	Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Secondary	Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128	rSBA-MenC antibody titre cut-off value assessed was =1:128	Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Secondary	Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128	rSBA-MenY antibody titre cut-off value assessed was =1:128	Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Secondary	rSBA-MenC Antibody Titres	Titres are expressed as geometric mean titres (GMTs)	Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Secondary	rSBA-MenY Antibody Titres	Titres are expressed as geometric mean titres (GMTs)	Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Secondary	Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)	Anti-PSC antibody concentration cut-off value assessed was =0.30 µg/mL	Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Secondary	Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)	Anti-PSC antibody concentration cut-off value assessed was =2.0 µg/mL	Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Secondary	Anti-PSC Antibody Concentrations	Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.	Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Secondary	Anti-PSY Antibody Concentrations	Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.	Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Secondary	Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).	Anti-tetanus toxoid antibody concentration cut-off value assessed was = 0.1 IU/mL	Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Secondary	Anti-T Antibody Concentrations	Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).	Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Secondary	Anti-diphtheria Antibody Concentrations	Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.	One month after the third dose (at study Month 3 - primary phase)
Secondary	Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations	Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).	One month after the third dose (at study Month 3 - primary phase)
Secondary	Anti-poliovirus Types 1, 2, 3 Antibody Titres	Titres are expressed as geometric mean titres (GMTs)	One month after the third dose (at study Month 3 - primary phase)
Secondary	Number of Seroprotected Subjects for Anti-diphtheria Antibodies	Seroprotection status is defined as anti-diphtheria antibody concentrations = 0.1 IU/mL	One month after the third dose (at study Month 3 - primary phase)
Secondary	Number of Seroprotected Subjects for Anti-hepatitis B Antibodies	Seroprotection status is defined as anti-HBs antibody concentrations = 10 mIU/mL	One month after the third dose (at study Month 3 - primary phase)
Secondary	Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies	Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres = 1:8	One month after the third dose (at study Month 3 - primary phase)
Secondary	Number of Subjects With Vaccine Response to PT, FHA and PRN	Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations = cut-off value), taking into consideration the decreasing maternal antibodies.	One month after the third dose (at study Month 3 - primary phase)
Secondary	Number of Subjects With Solicited Local Symptoms	Solicited local symptoms assessed were pain, redness and swelling.	During the 8-day (Day 0-7) follow-up period (during the primary phase)
Secondary	Number of Subjects With Solicited General Symptoms	Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature = 38.0 degrees Celsius (°C)).	During the 8-day (Day 0-7) follow-up period (during the primary phase)
Secondary	Number of Subjects With Unsolicited Adverse Events (AEs)	An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.	During the 31-day (Day 0-30) follow-up period (during the primary phase)
Secondary	Number of Subjects Reporting Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.	Over the full course of the primary phase (up to study Month 3 - primary phase)
Secondary	Number of Subjects With Solicited Local Symptoms	Solicited local symptoms assessed were pain, redness and swelling.	During the 8-day (Day 0-7) follow-up period (during the booster phase)
Secondary	Number of Subjects With Solicited General Symptoms	Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature = 38.0 degrees Celsius (°C)).	During the 8-day (Day 0-7) follow-up period (during the booster phase)
Secondary	Number of Subjects With Unsolicited Adverse Events (AEs)	An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.	During the 31-day (Day 0-30) follow-up period (during the booster phase)
Secondary	Number of Subjects Reporting Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.	Over the full course of the booster phase (up to study Month 1 - booster phase)

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