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
1 other identifier
interventional
521
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2003
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 11, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2006
CompletedResults Posted
Study results publicly available
February 20, 2017
CompletedAugust 6, 2018
June 1, 2018
2.4 years
September 13, 2005
December 23, 2016
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Seropositive Subjects for Anti-HAV Antibodies
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.
At one month after Dose 2 of Havrix® vaccine (Month 7-10)
Concentrations for Anti-HAV Antibodies
Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
At one month after Dose 2 of Havrix® vaccine (Month 7-10)
Secondary Outcomes (12)
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations
At one month after Prevnar™ vaccination (Day 30)
Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
At one month after Prevnar™ vaccination (Day 30)
Number of Seropositive Subjects for Anti-HAV Antibodies
At one month after Dose 1 of Havrix® vaccine (Day 30)
Concentrations for Anti-HAV Antibodies
At one month after Dose 1 of Havrix® vaccine (Day 30)
Number of Seropositive Subjects for Anti-HAV Antibodies
At one month after Dose 2 of Havrix® vaccine (Month 8-11)
- +7 more secondary outcomes
Study Arms (3)
Havrix Group
ACTIVE COMPARATORHealthy 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.
Havrix+Prevnar Group
EXPERIMENTALHealthy 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.
Prevnar Havrix Group
ACTIVE COMPARATORHealthy 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
Two doses, administered intramuscularly in the right anterolateral thigh.
One dose, administered intramuscularly in the left anterolateral thigh.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (18)
GSK Investigational Site
Centennial, Colorado, 80112, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Boston, Massachusetts, 02115, United States
GSK Investigational Site
Boston, Massachusetts, 02118, United States
GSK Investigational Site
Kalamazoo, Michigan, 49008, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Las Vegas, Nevada, 89014, United States
GSK Investigational Site
North Las Vegas, Nevada, 89025, United States
GSK Investigational Site
Stony Brook, New York, 11794, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27514, United States
GSK Investigational Site
University Heights, Ohio, 44118, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Dallas, Texas, 75235, United States
GSK Investigational Site
San Antonio, Texas, 78205-2489, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
Vancouver, Washington, 98664, United States
Related Publications (1)
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.
PMID: 18536623BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
None reported.
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
September 11, 2003
Primary Completion
January 16, 2006
Study Completion
January 16, 2006
Last Updated
August 6, 2018
Results First Posted
February 20, 2017
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.