- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00586612
Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants
Immunogenicity & Safety Study in Preterm & Full-term Infants of GSK Biologicals' Hib-MenC Vaccine, Menitorix™ Co-administered With Infanrix™ Penta & Prevenar™ at 2, 4, 6 Months & as a Booster With Infanrix™ IPV & Prevenar™ at 16-18 Months
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Barcelona, Spain, 08035
- GSK Investigational Site
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Bilbao, Spain, 48013
- GSK Investigational Site
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Burgos, Spain, 09005
- GSK Investigational Site
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Getafe, Spain, 28905
- GSK Investigational Site
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Madrid, Spain, 28041
- GSK Investigational Site
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Madrid, Spain, 28047
- GSK Investigational Site
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Malaga, Spain, 29010
- GSK Investigational Site
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Móstoles/Madrid, Spain, 28935
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All subjects must satisfy the following criteria at study entry:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
All preterm subjects must satisfy the following criteria at study entry:
- Born after a gestation period of less than or equal to 36 weeks (≤258 days).
- Medically stable, i.e. do not require significant medical support or ongoing management for debilitating disease and have demonstrated a clinical course of sustained recovery.
All full-term subjects must satisfy the following criteria at study entry:
- Born after a gestation period between and including 37 and 42 weeks (≥259 days and ≤294 days).
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (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.
- Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine until the last study visit, except measles-mumps-rubella (MMR) and varicella vaccines which may be given according to local immunisation practices and except rotavirus oral vaccine which is allowed at anytime during the study after hospital discharge as per prescribing information.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C and or Streptococcus pneumoniae disease, with the exception of hepatitis B vaccine or BCG vaccine given in the first month of life according to the national recommendations (although BCG and hepatitis B vaccines should have been given outside a 30-day window from the first administration of study vaccines).
- History of diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins (with the exception of monoclonal antibodies against respiratory syncytial virus [RSV]) and/or any blood products within one month (30 days) preceding the first dose of study vaccines.
- Planned administration of immunoglobulins and/or any blood products during the active phase of the study.
Specific criteria for the booster part of the study (to be checked at Visit 5, study month 14):
- History of diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease.
- Previous vaccination, except the study vaccines and hepatitis birth dose, against diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease.
- Previous booster vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and/or S. pneumoniae disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Preterm group
Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
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Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
Intramuscular injection, 3 doses in the primary study
Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
Intramuscular injection, 1 dose in the Booster study.
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ACTIVE_COMPARATOR: Full-term group
Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
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Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
Intramuscular injection, 3 doses in the primary study
Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
Intramuscular injection, 1 dose in the Booster study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)
Time Frame: One month after the third vaccination
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Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.
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One month after the third vaccination
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Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8
Time Frame: One month after the third vaccination
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rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.
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One month after the third vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values
Time Frame: Before vaccination (at Day 0)
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Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.
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Before vaccination (at Day 0)
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Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter
Time Frame: One month after the third vaccination
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Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL).
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One month after the third vaccination
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Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values
Time Frame: Before vaccination (at Day 0)
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rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.
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Before vaccination (at Day 0)
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Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values
Time Frame: One month after the third vaccination
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rSBA-MenC titer cut-off values assessed include 1:32 and 1:128.
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One month after the third vaccination
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Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values
Time Frame: Before vaccination (at Day 0)
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Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.
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Before vaccination (at Day 0)
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Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values
Time Frame: One month after the third dose
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Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.
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One month after the third dose
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Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values
Time Frame: Before vaccination (at Day 0)
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Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.
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Before vaccination (at Day 0)
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Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values
Time Frame: One month after the third dose
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Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.
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One month after the third dose
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Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration
Time Frame: Before vaccination (at Day 0)
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Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).
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Before vaccination (at Day 0)
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Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration
Time Frame: One month after the third dose
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Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).
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One month after the third dose
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Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration
Time Frame: Before vaccination (at Day 0)
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Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).
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Before vaccination (at Day 0)
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Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration
Time Frame: One month after the third dose
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Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).
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One month after the third dose
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Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer
Time Frame: Before vaccination (at Day 0)
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rSBA-MenC titers are given as geometric mean titers (GMTs).
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Before vaccination (at Day 0)
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Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer
Time Frame: One month after the third dose
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rSBA-MenC titers are given as geometric mean titers (GMTs).
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One month after the third dose
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Number of Subjects Reporting Solicited Local Symptoms
Time Frame: During the 4-day follow-up period after any primary vaccination dose
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Solicited local symptoms assessed include pain, redness and swelling and are presented across doses.
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During the 4-day follow-up period after any primary vaccination dose
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Number of Subjects Reporting Solicited General Symptoms
Time Frame: During the 4-day follow-up period after any primary vaccination dose
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Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses.
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During the 4-day follow-up period after any primary vaccination dose
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Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Time Frame: Within 31 days after each primary vaccination
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Unsolicited AE covers any AE 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.
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Within 31 days after each primary vaccination
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Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame: Throughout the entire primary vaccination phase
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SAEs assessed include medical occurrences that result in death, is 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.
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Throughout the entire primary vaccination phase
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Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL)
Time Frame: Prior to (Month 14) and one month after the booster vaccination (Month 15)
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Anti-PRP antibody cut-off value assessed was 0.15 migrogram per milliliter (µg/mL).
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Prior to (Month 14) and one month after the booster vaccination (Month 15)
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Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL)
Time Frame: Prior to (Month 14) and one month after the booster vaccination (Month 15)
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Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL).
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Prior to (Month 14) and one month after the booster vaccination (Month 15)
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Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values
Time Frame: Prior to (Month 14) and one month after the booster vaccination (Month 15)
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rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.
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Prior to (Month 14) and one month after the booster vaccination (Month 15)
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Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values
Time Frame: Prior to (Month 14) and one month after the booster vaccination (Month 15)
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Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL.
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Prior to (Month 14) and one month after the booster vaccination (Month 15)
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Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values
Time Frame: Prior to (Month 14) the booster vaccination
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Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL. Note: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component. |
Prior to (Month 14) the booster vaccination
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Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration
Time Frame: Prior to (Month 14) and one month after the booster vaccination (Month 15)
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Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL).
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Prior to (Month 14) and one month after the booster vaccination (Month 15)
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Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration
Time Frame: Prior to (Month 14) the booster vaccination
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Anti-HBs concentrations are given as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL). Note: Planned analysis in the protocol of HBs after the booster dose was not performed as booster vaccines did not contain HBs component. |
Prior to (Month 14) the booster vaccination
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Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer
Time Frame: Prior to (Month 14) and one month after the booster vaccination (Month 15)
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rSBA-MenC titers are given as geometric mean titers (GMTs).
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Prior to (Month 14) and one month after the booster vaccination (Month 15)
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Number of Subjects Reporting Solicited Symptoms (Local and General)
Time Frame: During the 4-day follow-up period following booster vaccination
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Solicited local symptoms assessed include pain, redness and swelling.
Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite.
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During the 4-day follow-up period following booster vaccination
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Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Time Frame: Within 31 days after the booster vaccination (month 15)
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Unsolicited AE covers any AE 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.
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Within 31 days after the booster vaccination (month 15)
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Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame: 31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15)
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SAEs assessed include medical occurrences that result in death, is 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. Period 1 is defined as 31 days after last primary vaccination until administration of booster dose (Month 14). Period 2 is defined as the administration of the booster dose until the end of the study (Month 15). |
31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110215
- 110217 (GSK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Individual Participant Data Set
Information identifier: 110215Information comments: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study are summarised with 110217 on the GSK Clinical Study Register.
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Informed Consent Form
Information identifier: 110215Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 110215Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 110215Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 110215Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 110215Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 110215Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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