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

• ClinicalTrials.gov Identifier: NCT00129116
• Recruitment Status: Completed
• First Posted: August 11, 2005
• Results First Posted: July 23, 2012
• Last Update Posted: August 27, 2018
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Haemophilus Influenzae Type b; Neisseria Meningitidis	Biological: Hib-MenCY-TT vaccine; Biological: Hib-MenC-TT vaccine; Biological: Menjugate ®; Biological: Infanrix penta ®; Biological: Infanrix hexa ®	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 388 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• 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 Start Date: March 1, 2003
• Actual Primary Completion Date: December 1, 2003
• Actual Study Completion Date: December 16, 2003

Arms and Interventions

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 Name: 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 Name: 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 Name: 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: Hib-MenC-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 Name: DTPa-HBV-IPV vaccine
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 Name: DTPa-HBV-IPV/Hib vaccine

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). [ Time Frame: One month after dose 3 (at study Month 3 - primary phase) ]
   Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
2. Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 [ Time Frame: One month after dose 3 (at study Month 3 - primary phase) ]
   rSBA-MenC antibody titre cut-off value assessed was ≥1:8
3. Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 [ Time Frame: One month after dose 3 (at study Month 3 - primary phase) ]
   rSBA-MenY antibody titre cut-off value assessed was ≥1:8
4. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). [ Time Frame: One month after the booster vaccination (at study Month 1 - booster phase) ]
   Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
5. Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 [ Time Frame: One month after the booster vaccination (at study Month 1 - booster phase) ]
   rSBA-MenC antibody titre cut-off value assessed was ≥1:8
6. Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 [ Time Frame: One month after the booster vaccination (at study Month 1 - booster phase) ]
   rSBA-MenY antibody titre cut-off value assessed was ≥1:8

Secondary Outcome Measures :

1. Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 [ Time Frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase) ]
   rSBA-MenC antibody titre cut-off value assessed was ≥1:8
2. Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 [ Time Frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase) ]
   rSBA-MenY antibody titre cut-off value assessed was ≥1:8
3. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). [ Time Frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase) ]
   Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
4. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). [ Time Frame: Prior to the booster vaccination (at study Month 0 - booster phase) ]
   Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
5. Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 [ Time Frame: Prior to the booster vaccination (at study Month 0 - booster phase) ]
   rSBA-MenC antibody titre cut-off value assessed was ≥1:8
6. Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 [ Time Frame: Prior to the booster vaccination (at study Month 0 - booster phase) ]
   rSBA-MenY antibody titre cut-off value assessed was ≥1:8
7. rSBA-MenC Antibody Titres [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ]
   Titres are expressed as geometric mean titres (GMTs)
8. rSBA-MenY Antibody Titres [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ]
   Titres are expressed as geometric mean titres (GMTs)
9. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ]
   Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
10. Anti-PRP Antibody Concentrations [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
11. Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ]
    Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
12. Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ]
    Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL
13. Anti-PSC Antibody Concentrations [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
14. Anti-PSY Antibody Concentrations [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
15. Anti-tetanus Antibody Concentrations [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
16. Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.
17. Number of Seroprotected Subjects for Anti-tetanus Antibodies [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ]
    Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)
18. 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) [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ]
    Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.
19. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ]
    Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
20. Anti-PRP Antibody Concentrations [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
21. Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ]
    rSBA-MenC antibody titre cut-off value assessed was ≥1:128
22. Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ]
    rSBA-MenY antibody titre cut-off value assessed was ≥1:128
23. rSBA-MenC Antibody Titres [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ]
    Titres are expressed as geometric mean titres (GMTs)
24. rSBA-MenY Antibody Titres [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ]
    Titres are expressed as geometric mean titres (GMTs)
25. Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ]
    Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
26. Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ]
    Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL
27. Anti-PSC Antibody Concentrations [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
28. Anti-PSY Antibody Concentrations [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
29. Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ]
    Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL
30. Anti-T Antibody Concentrations [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
31. Anti-diphtheria Antibody Concentrations [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.
32. Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).
33. Anti-poliovirus Types 1, 2, 3 Antibody Titres [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]
    Titres are expressed as geometric mean titres (GMTs)
34. Number of Seroprotected Subjects for Anti-diphtheria Antibodies [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]
    Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL
35. Number of Seroprotected Subjects for Anti-hepatitis B Antibodies [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]
    Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL
36. Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]
    Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8
37. Number of Subjects With Vaccine Response to PT, FHA and PRN [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ]
    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.
38. Number of Subjects With Solicited Local Symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period (during the primary phase) ]
    Solicited local symptoms assessed were pain, redness and swelling.
39. Number of Subjects With Solicited General Symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period (during the primary phase) ]
    Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
40. Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Day 0-30) follow-up period (during the primary phase) ]
    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.
41. Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Over the full course of the primary phase (up to study Month 3 - primary phase) ]
    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.
42. Number of Subjects With Solicited Local Symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period (during the booster phase) ]
    Solicited local symptoms assessed were pain, redness and swelling.
43. Number of Subjects With Solicited General Symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period (during the booster phase) ]
    Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
44. Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Day 0-30) follow-up period (during the booster phase) ]
    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.
45. Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Over the full course of the booster phase (up to study Month 1 - booster phase) ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 6 Weeks to 12 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Belgium

GSK Investigational Site

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

Germany

GSK Investigational Site

Cham, Bayern, Germany, 93413

GSK Investigational Site

Kaufering, Bayern, Germany, 86916

GSK Investigational Site

Muenchen, Bayern, Germany, 80939

GSK Investigational Site

Muenchen, Bayern, Germany, 81675

GSK Investigational Site

Noerdlingen, Bayern, Germany, 86720

GSK Investigational Site

Olching, Bayern, Germany, 82140

GSK Investigational Site

Niedernhausen, Hessen, Germany, 65527

GSK Investigational Site

Detmold, Nordrhein-Westfalen, Germany, 32756

GSK Investigational Site

Kirchlengern, Nordrhein-Westfalen, Germany, 32278

GSK Investigational Site

Loehne, Nordrhein-Westfalen, Germany, 32584

GSK Investigational Site

Leipzig, Sachsen, Germany, 04178

GSK Investigational Site

Bredstedt, Schleswig-Holstein, Germany, 25821

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany, 24937

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany, 24943

GSK Investigational Site

Berlin, Germany, 10315

GSK Investigational Site

Berlin, Germany, 12627

GSK Investigational Site

Berlin, Germany, 13355

GSK Investigational Site

Berlin, Germany, 14197

GSK Investigational Site

Hamburg, Germany, 22307

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

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 Data/Documents: Informed Consent Form 

Identifier: 792014/003
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 792014/003
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 792014/003
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 792014/003
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 792014/003
For additional information about this study please refer to the GSK Clinical Study Register

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. Review.

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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00129116
• Other Study ID Numbers: 792014/003; 100381 ( Other Identifier: GSK )
• First Posted: August 11, 2005
• Results First Posted: July 23, 2012
• Last Update Posted: August 27, 2018
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.

Keywords provided by GlaxoSmithKline:

Invasive bacterial disease caused by Hib; Neisseria meningitidis serogroups C & Y

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs