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Completed

NCT Number: 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

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.

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Key information

Conditions

Haemophilus Influenzae Type b Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Haemophilus Infections Infections Neisseria Meningitidis Pasteurellaceae Infections

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Asse, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hib-MenCY-TT vaccine

Biological

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

Hib-MenC-TT vaccine

Biological

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

Menjugate ®

Biological

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

Infanrix penta ®

Biological

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Other names: DTPa-HBV-IPV vaccine

Infanrix hexa ®

Biological

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Other names: DTPa-HBV-IPV/Hib vaccine

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Aug 11, 2005
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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