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Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age

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ClinicalTrials.gov Identifier: NCT00197002
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : February 20, 2017
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Results First Submitted Date  ICMJE December 23, 2016
Results First Posted Date  ICMJE February 20, 2017
Last Update Posted Date August 6, 2018
Actual Study Start Date  ICMJE September 11, 2003
Actual Primary Completion Date January 16, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2016)
  • Number of Seropositive Subjects for Anti-HAV Antibodies [ Time Frame: At one month after Dose 2 of Havrix® vaccine (Month 7-10) ]
    Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination.
  • Concentrations for Anti-HAV Antibodies [ Time Frame: At one month after Dose 2 of Havrix® vaccine (Month 7-10) ]
    Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Immune response for Havrix following the second dose of Havrix in both the Havrix group and the Havrix + Prevnar group.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2016)
  • Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations [ Time Frame: At one month after Prevnar™ vaccination (Day 30) ]
    Antibody concentrations against pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL).
  • Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F [ Time Frame: At one month after Prevnar™ vaccination (Day 30) ]
    The immune response was defined, with respect to anti-pneumococcal response rates, as an antibody concentration equal to or above (≥) 0.05 μg/mL.
  • Number of Seropositive Subjects for Anti-HAV Antibodies [ Time Frame: At one month after Dose 1 of Havrix® vaccine (Day 30) ]
    Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.
  • Concentrations for Anti-HAV Antibodies [ Time Frame: At one month after Dose 1 of Havrix® vaccine (Day 30) ]
    Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).
  • Number of Seropositive Subjects for Anti-HAV Antibodies [ Time Frame: At one month after Dose 2 of Havrix® vaccine (Month 8-11) ]
    Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.
  • Concentrations for Anti-HAV Antibodies [ Time Frame: At one month after Dose 2 of Havrix® vaccine (Month 8-11) ]
    Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).
  • Number of Subjects With Vaccine Response to Anti-HAV Antibodies [ Time Frame: One month after Dose 2 of Havrix® vaccine (Month 7-10/8-10) ]
    The vaccine response was defined as:
    1. a detectable anti-HAV antibody concentration one month after Dose 2 in subjects who were initially seronegative (antibody concentrations < 15 mIU/mL for anti-HAV); or
    2. a 2-fold increase above the pre-vaccination concentration one month after Dose 2 in subjects who were initially seropositive (antibody concentrations ≥ 15 mIU/mL for anti-HAV).
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses ]
    Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.
  • Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Day 0-30) follow-up period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
  • Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs) [ Time Frame: During the Active Phase (from Day 0 to Day 30 after final vaccine dose for each subject) ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that 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 With SAEs, NCIs and MSEs [ Time Frame: During the Extended Safety Follow-up (ESFU) Phase (from Day 30 to 6 months after final vaccine dose) ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Immune response for Prevnar following vaccination in both the Havrix + Prevnar group and the Prevnar followed by Havrix group.
  • Immune response for Havrix following the first dose of Havrix in all groups. The other secondary outcome measure is safety of the study vaccines.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
Official Title  ICMJE A Phase IIIb, Open, Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine Administered on a 0-6 Mth Schedule Concomitantly With Wyeth Lederle's Pneumococcal Conjugate Vaccine in Healthy Children 15 Months of Age
Brief Summary This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age.
Detailed Description An open, controlled comparison of Havrix administered alone or with Prevnar. The three groups evaluated are: 1) Havrix alone, 2) Havrix plus Prevnar and 3) Prevnar followed by Havrix one month later.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hepatitis A
Intervention  ICMJE
  • Biological: GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)
    Two doses, administered intramuscularly in the right anterolateral thigh.
  • Biological: Prevnar™
    One dose, administered intramuscularly in the left anterolateral thigh.
Study Arms  ICMJE
  • Active Comparator: Havrix Group
    Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
    Intervention: Biological: GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)
  • Experimental: Havrix+Prevnar Group
    Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
    Interventions:
    • Biological: GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)
    • Biological: Prevnar™
  • Active Comparator: Prevnar Havrix Group
    Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
    Interventions:
    • Biological: GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)
    • Biological: Prevnar™
Publications * Trofa AF, Levin M, Marchant CD, Hedrick J, Blatter MM. Immunogenicity and safety of an inactivated hepatitis a vaccine administered concomitantly with a pneumococcal conjugate vaccine in healthy children 15 months of age. Pediatr Infect Dis J. 2008 Jul;27(7):658-60. doi: 10.1097/INF.0b013e31816907bd.

*   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: April 5, 2012)
521
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
480
Actual Study Completion Date  ICMJE January 16, 2006
Actual Primary Completion Date January 16, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A male or female child 12 or 13 months of age at the time of entry into the Enrollment Phase,
  • Free of obvious health problems,
  • Subjects must have previously received three doses of Prevnar in his/her first year of life.

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine within 42 days preceding the first dose of study vaccine, or planned use during the study period,
  • Chronic administration of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, less than 0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.),
  • Administration of the ACIP-recommended fourth dose of Prevnar prior to entering the Enrollment Phase of the study,
  • Planned administration or administration of any vaccine not foreseen by the study protocol within the period of 42 days before and 30 days after each dose of study vaccine(s),
  • Previous vaccination against hepatitis A,
  • History of hepatitis A or known exposure to hepatitis A,
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection,
  • A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection,
  • History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of Havrix (e.g., neomycin, 2-phenoxyethanol) or Prevnar (e.g., diphtheria toxoid),
  • Major congenital defects or serious chronic illness,
  • History of any neurologic disorder (history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject),
  • Acute disease, defined as the presence of a moderate or severe illness with or without fever, at the time of vaccination,
  • Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 13 Months   (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 NCT00197002
Other Study ID Numbers  ICMJE 208109/220
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 June 2018

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