Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00614614
Previous Study | Return to List | Next Study

Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00614614
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : July 20, 2012
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE January 31, 2008
First Posted Date  ICMJE February 13, 2008
Results First Submitted Date  ICMJE June 15, 2012
Results First Posted Date  ICMJE July 20, 2012
Last Update Posted Date September 21, 2018
Study Start Date  ICMJE February 13, 2008
Actual Primary Completion Date July 31, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
  • Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group [ Time Frame: One month post vaccination at 12-15 months of age (Month 11) ]
    The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
  • Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group [ Time Frame: One month post vaccination at 15-18 months of age (Month 14) ]
    The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
  • Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group [ Time Frame: One month post vaccination at 12-15 months of age (Month 11) ]
    Antibody titers were expressed as Geometric mean titers (GMTs)
  • Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group [ Time Frame: One month post vaccination at 15-18 months of age (Month 14) ]
    Antibody titers were expressed as Geometric mean titers (GMTs)
  • Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group [ Time Frame: One month post vaccination at 15-18 months of age (Month 14) ]
    The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).
  • Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group [ Time Frame: One month post vaccination at 12-15 months of age (Month 11) ]
    Antibody titers were expressed as Geometric mean titers (GMTs)
  • Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group [ Time Frame: One month post vaccination at 12-15 months of age (Month 11) ]
    The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
  • Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group [ Time Frame: One month after vaccination at 15-18 months of age (Month 14) ]
    Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2008)
  • hSBA-MenC, and hSBA-MenY GMTs [ Time Frame: One month after vaccination at 12-15 months of age ]
  • hSBA-MenA, hSBA-MenW-135 titers above protocol-specified cut-off [ Time Frame: One month after vaccination at 12-15 months of age ]
  • Anti-PRP antibody concentrations >=1.0 µg/mL [ Time Frame: One month after vaccination at 12-15 months of age ]
  • Anti-D concentrations >=1.0 IU/mL [ Time Frame: One month after vaccination at 15-18 months of age ]
  • Anti-T concentrations >=1.0 IU/mL [ Time Frame: One month after vaccination at 15-18 months of age ]
  • Anti-PT, anti-FHA and anti-PRN GMCs [ Time Frame: One month after vaccination at 15-18 months of age ]
  • hSBA-MenC, and hSBA-MenY GMTs [ Time Frame: One month after vaccination at 15-18 months of age ]
  • hSBA-MenA, hSBA-MenW-135 titers above protocol-specified cut-off [ Time Frame: One month after vaccination at 15-18 months of age ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2012)
  • Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group [ Time Frame: One month after vaccination at 12-15 months of age (Month 11) ]
    The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4
  • Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group [ Time Frame: One month after vaccination at 12-15 months of age (Month 11) ]
    The cut-off values assessed for hSBA-MenA and hSBA-MenW-135 were greater than or equal to (≥) 1:4
  • Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group [ Time Frame: One month after vaccination at 12-15 months of age (Month 11) ]
    Antibody titers were expressed as Geometric mean titers (GMTs)
  • Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group [ Time Frame: Prior to vaccination at 15-18 months of age (Month 13) ]
    Antibody titers were expressed as Geometric mean titers (GMTs)
  • Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group [ Time Frame: Prior to vaccination at 15-18 months of age (Month 13) ]
    The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 and ≥ 1:8
  • Anti-D and Anti-T Geometric Mean Antibody Concentrations [ Time Frame: One month after vaccination with Infanrix at 15-18 months of age (Month 14) ]
    Concentrations were provided as Geometric Mean Concentrations(GMCs) and expressed as International Units per milliliter (IU/mL).
  • Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value [ Time Frame: One month after vaccination with Infanrix at 15-18 months of age (Month 14) ]
    The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).
  • Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value [ Time Frame: One month after vaccination with Infanrix at 15-18 months of age (Month 14) ]
    The cut-off values assessed were greater than or equal to (≥) 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
  • Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group [ Time Frame: One month after vaccination at 15-18 months of age (Month 14) ]
    Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
  • Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group [ Time Frame: One month after vaccination at 15-18 months of age (Month 14) ]
    The cut-off values assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).
  • Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group [ Time Frame: One month after vaccination at 15-18 months of age (Month 14) ]
    The cut-off values assessed for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY were greater than or equal to (≥) 1:4
  • Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group [ Time Frame: One month after vaccination with Infanrix at 15-18 months of age (Month 14) ]
    Antibody titers were expressed as Geometric mean titers (GMTs)
  • Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine [ Time Frame: During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase ]
    Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was greater than (>) 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.
  • Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase [ Time Frame: During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination ]
    Any fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 fever was axillary temperature > 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
  • Number of Subjects Reporting Any Rash [ Time Frame: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22) ]
    Examples of rash included hives, idiopathic thrombocytopenic purpura, petechiae.
  • Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine [ Time Frame: During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase ]
    Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.
  • Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits [ Time Frame: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22) ]
    NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
  • Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits [ Time Frame: From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13) ]
    NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination [ Time Frame: During a 31-day follow-up period (Day 0-30) ]
    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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
  • Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination [ Time Frame: During the 31-day follow-up period (Day 0-30) ]
    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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
  • Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) [ Time Frame: From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13). ]
    SAEs assessed include 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
  • Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) [ Time Frame: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22) ]
    SAEs assessed include 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2008)
  • Anti-PRP GMCs and antibody concentrations >=0.15 µg/mL [ Time Frame: One month after vaccination at 12-15 months of age ]
  • rSBA-MenC and rSBA-MenY GMTs and antibody titers above protocol-specified cut-offs in a subset of 30% of subjects [ Time Frame: One month after vaccination at 12-15 months of age ]
  • Anti-PSC and anti-PSY antibody GMCs and antibody concentrations >=0.3 µg/mL and >=2.0 µg/mL in a subset of 30% of subjects [ Time Frame: One month after vaccination at 12-15 months of age ]
  • hSBA-MenC and hSBA-MenY antibody titers above protocol-specified cut-offs [ Time Frame: One month after vaccination at 12-15 months of age ]
  • hSBA-MenA and hSBA MenW-135 GMTs and antibody titers above protocol-specified cut-off [ Time Frame: One month after vaccination at 12-15 months of age ]
  • rSBA-MenA and rSBA-MenW-135 GMTs and antibody titers above protocol-specified cut-offs in a subset of 30% of subjects [ Time Frame: One month after vaccination at 12-15 months of age ]
  • Anti-PSA and anti-PSW-135 antibody GMCs and antibody concentrations >=0.3 µg/mL and >=2.0 µg/mL in a subset of 30% of subjects [ Time Frame: One month after vaccination at 12-15 months of age ]
  • hSBA-MenC, and hSBA-MenY GMTs [ Time Frame: Prior to vaccination at 15-18 months of age ]
  • hSBA-MenC and MenY titers above protocol-specified cut-offs [ Time Frame: Prior to vaccination at 15-18 months of age ]
  • Anti-D and anti-T GMCs [ Time Frame: One month after vaccination at 15-18 months of age ]
  • Anti-PT, anti-FHA and anti-PRN concentrations >=5 ELISA Units (EL.U)/mL [ Time Frame: One month after vaccination at 15-18 months of age ]
  • Anti-D and anti-T seroprotection rates (antibody concentrations >=0.1 IU/mL) [ Time Frame: One month after vaccination at 15-18 months of age ]
  • hSBA- MenA, hSBA-MenW-135 GMTs [ Time Frame: One month after vaccination at 15-18 months of age ]
  • hSBA-MenC and hSBA-MenY titers above protocol-specified cut-off [ Time Frame: One month after vaccination at 15-18 months of age ]
  • rSBA- MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs and antibody titers above protocol-specified cut-offs in a subset of 30% of subjects [ Time Frame: One month after vaccination at 15-18 months of age ]
  • Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY GMCs and antibody concentrations >=0.3 µg/mL and >=2.0 µg/mL in a subset of 30% of subjects [ Time Frame: One month after vaccination at 15-18 months of age ]
  • Occurrence of solicited local and general symptoms [ Time Frame: On Days 0-7 after booster vaccination ]
  • Occurrence of unsolicited symptoms [ Time Frame: Up to one month (Days 0-30) after booster vaccination ]
  • Occurrence of serious adverse events (SAEs) and/or the specific AEs of: - new onset of chronic illness(es), - conditions prompting ER visits [ Time Frame: From the first primary study dose up to/excluding the first booster study dose ]
  • Occurrence of SAEs and/or the specific AEs of: - new onset of chronic illness(es), - rash and/or - conditions prompting emergency room (ER) visits [ Time Frame: From the first booster study dose up to six months after the last vaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
Official Title  ICMJE Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Meningococcal Vaccine 134612 Given at 12-15 Months of Age or at 15-18 Months of Age (Co-administered With Infanrix®) in Primed Healthy Toddlers.
Brief Summary The purpose of the study is to characterize the immunogenicity & safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.
Detailed Description

The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In addition, this study will provide immunogenicity and safety data on the co-administration of Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone.

Depending on the group the subject is assigned to, one or two blood samples will be taken out of the subject's arm during the study.

The protocol posting has been updated following a protocol amendment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Infections, Meningococcal
Intervention  ICMJE
  • Biological: GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)
    One dose in the booster phase as intramuscular injection
    Other Name: Nimenrix
  • Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)
    Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection
    Other Name: Menhibrix
  • Biological: Infanrix®
    One dose as intramuscular injection
  • Biological: ActHIB®
    Three doses in the priming phase as intramuscular injection
  • Biological: Pediarix®
    Three doses in the priming phase as intramuscular injection
Study Arms  ICMJE
  • Experimental: Menhibrix 1 Group
    Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 1 Group] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Menhibrix 2 Group], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 2 Group].
    Interventions:
    • Biological: GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)
    • Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)
    • Biological: Infanrix®
    • Biological: Pediarix®
  • Active Comparator: ActHIB- Infanrix Group
    Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age and 1 booster dose of Infanrix vaccine at 15-18 months of age.
    Interventions:
    • Biological: Infanrix®
    • Biological: ActHIB®
    • Biological: Pediarix®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2010)
1558
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2008)
1176
Actual Study Completion Date  ICMJE September 17, 2009
Actual Primary Completion Date July 31, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after 36 weeks gestation.
  • For inclusion in the booster phase, subjects must have received all three doses in the primary phase.

Exclusion Criteria:

Exclusion criteria for enrolment (primary phase)

  • 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
  • Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
  • History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, polio or pertussis diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at time of enrollment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Exclusion criteria for enrolment (booster phase)

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of entry into the booster phase (Visit 4) with the exception of Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine is allowed throughout the study)
  • Planned administration/administration of a fourth dose of Prevnar® within 30 days of a booster dose of Infanrix®
  • Previous administration of a booster dose of Hib prior to entry to the booster phase.
  • Previous administration of a primary dose of Hib vaccine that is not part of the study protocol.
  • Previous vaccination against Neisseria meningitidis that is not part of the study protocol.
  • Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the primary phase of the study.
  • History of Neisseria meningitidis, Hib, diphtheria, tetanus or pertussis diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at time of enrollment.
  • Administration of immunoglobulins and/or any blood products within the past 3 months or planned administration during the study period.
  • Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 12 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00614614
Other Study ID Numbers  ICMJE 110870
110871 ( Other Identifier: GSK )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP