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Completed

NCT Number: NCT00127855

Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 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, North Adelaide, South Australia, Australia

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Vaccinated against hepatitis B at birth.
  • Born after a gestation period of 36 - 42 weeks.

Exclusion criteria

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth
  • Any chronic drug therapy to be continued during the study period.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine(s).
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
  • History of or known exposure to diphtheria, tetanus, pertussis, polio, or invasive diseases due to N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Treatment and study plan

Hib-MenCY-TT vaccine (MenHibrix)

Biological

Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively

Meningitec®

Biological

Three doses were administered IM in right lower thigh at Months 0,2 and 4.

ActHIB®

Biological

Three doses were administered IM in left thigh at Months 0,2 and 4.

Infanrix® Penta

Biological

Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.

Other names: DTPa-HBV-IPV vaccine

Prevenar®

Biological

Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.

Mencevax® ACWY

Biological

One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.

PRP (Polyribosyl Ribitol Phosphate)

Biological

One dose was administered IM in deltoid region of left arm at Month 10 as booster.

Primary outcomes

  1. Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter

    Time frame: One month after primary vaccination (Month 5)

    The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).

  2. Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8

    Time frame: One month after primary vaccination (Month 5)

    The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

  3. Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8

    Time frame: One month after primary vaccination (Month 5)

    The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

Secondary outcomes

  1. Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8

    Time frame: Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

    The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

  2. Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

    Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

  3. Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8

    Time frame: Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

    The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

  4. Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

    Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

  5. Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

    The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).

  6. Anti-polysaccharide C (PSC) Antibody Concentration

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

    Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).

  7. Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

    The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).

  8. Anti-polysaccharide Y (PSY) Antibody Concentration

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

    Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).

  9. Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

    The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.

  10. Anti-PRP Antibody Concentration

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

    Concentrations are presented as GMCs and expressed as µg/mL.

  11. Number of Subjects Seroprotected for Anti-diphtheria Antibodies

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).

  12. Anti-diphtheria Antibody Concentrations

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).

  13. Number of Subjects Seroprotected for Anti-tetanus Antibodies

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).

  14. Anti-tetanus Antibody Concentrations

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).

  15. Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

  16. Anti- FHA Antibody Concentrations

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

  17. Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

  18. Anti-PRN Antibody Concentrations

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

  19. Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

  20. Anti- PT Antibody Concentrations

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

  21. Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).

  22. Anti- HBs Antibody Concentrations

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).

  23. Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.

  24. Anti-poliovirus Types 1, 2 and 3 Antibody Titers

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.

  25. Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).

  26. Anti-pneumococcal Antibody Concentrations

    Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

    Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).

  27. Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course

    Time frame: During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course

    Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).

  28. Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose

    Time frame: During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose

    Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).

  29. Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course

    Time frame: During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course

    Unsolicited adverse event covers any adverse event 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.

  30. Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose

    Time frame: During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose

    Unsolicited adverse event covers any adverse event 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.

  31. Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course

    Time frame: Up to one month after the 3-dose primary vaccination course (Month 5)

    Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

  32. Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose

    Time frame: Up to one month following administration of the polysaccharide challenge dose (Month 11)

    Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

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 (Including Immune Memory), Reactogenicity and Safety of Three Different Formulations of the GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups CY Conjugate Vaccine Given Concomitantly With Infanrix® Penta and Prevenar®, Versus ActHIB® and Meningitec® Given Concomitantly With Infanrix® Penta and Versus ActHIB® Given Concomitantly With Infanrix® Penta and Prevenar® in Infants According to a 2-4-6 Month Schedule.

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Aug 9, 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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