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

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

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.

Study Overview

• Status: Completed
• Conditions: Neisseria Meningitidis; Haemophilus Influenzae Type b
• Intervention / Treatment: Biological: Hib-MenCY-TT vaccine; Biological: Infanrix penta ®; Biological: Hib-MenC-TT vaccine; Biological: Menjugate ®; Biological: Infanrix hexa ®

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

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menhibrix F1/Infanrix-penta Group; Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Biological: Hib-MenCY-TT vaccine; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.; Biological: Infanrix penta ®; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.; Other Names: DTPa-HBV-IPV vaccine
Experimental: Menhibrix F2/Infanrix-penta Group; Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Biological: Hib-MenCY-TT vaccine; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.; Biological: Infanrix penta ®; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.; Other Names: DTPa-HBV-IPV vaccine
Experimental: Menhibrix F3/Infanrix-penta Group; Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Biological: Hib-MenCY-TT vaccine; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.; Biological: Infanrix penta ®; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.; Other Names: DTPa-HBV-IPV vaccine
Experimental: Menitorix/Infanrix-penta Group; Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Biological: Infanrix penta ®; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.; Other Names: DTPa-HBV-IPV vaccine; Biological: Hib-MenC-TT vaccine; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Active Comparator: Menjugate/Infanrix-hexa Group; Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Biological: Menjugate ®; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.; Biological: Infanrix hexa ®; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.; Other Names: DTPa-HBV-IPV/Hib vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): December 1, 2003
• Study Completion (Actual): December 16, 2003

Study Registration Dates

• First Submitted: August 10, 2005
• First Submitted That Met QC Criteria: August 10, 2005
• First Posted (Estimate): August 11, 2005

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Invasive bacterial disease caused by Hib; Neisseria meningitidis serogroups C & Y
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 792014/003; 100381 (Other Identifier: GSK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 792014/003
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 792014/003
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Dataset Specification
   Information identifier: 792014/003
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Individual Participant Data Set
   Information identifier: 792014/003
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 792014/003
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register