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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00197002
First Posted: September 20, 2005
Last Update Posted: February 20, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
September 13, 2005
September 20, 2005
December 23, 2016
February 20, 2017
February 20, 2017
September 2003
May 2006   (Final data collection date for primary outcome measure)
  • 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).
Immune response for Havrix following the second dose of Havrix in both the Havrix group and the Havrix + Prevnar group.
Complete list of historical versions of study NCT00197002 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hepatitis A
Biological: Hepatitis A
Two doses
Not Provided
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.
 
Completed
521
May 2006
May 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Months to 13 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00197002
208109/220
Not Provided
Not Provided
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.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

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