Clinical trial NCT00197002: Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 521
Sex: ALL
Minimum age (years): 12
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Seropositive Subjects for Anti-HAV Antibodies
timeFrame: At one month after Dose 2 of Havrix® vaccine (Month 7-10)
measure: Concentrations for Anti-HAV Antibodies
timeFrame: At one month after Dose 2 of Havrix® vaccine (Month 7-10)
Secondary outcomes:
measure: Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations
timeFrame: At one month after Prevnar™ vaccination (Day 30)
measure: Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
timeFrame: At one month after Prevnar™ vaccination (Day 30)
measure: Number of Seropositive Subjects for Anti-HAV Antibodies
timeFrame: At one month after Dose 1 of Havrix® vaccine (Day 30)
measure: Concentrations for Anti-HAV Antibodies
timeFrame: At one month after Dose 1 of Havrix® vaccine (Day 30)
measure: Number of Seropositive Subjects for Anti-HAV Antibodies
timeFrame: At one month after Dose 2 of Havrix® vaccine (Month 8-11)
measure: Concentrations for Anti-HAV Antibodies
timeFrame: At one month after Dose 2 of Havrix® vaccine (Month 8-11)
measure: Number of Subjects With Vaccine Response to Anti-HAV Antibodies
timeFrame: One month after Dose 2 of Havrix® vaccine (Month 7-10/8-10)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Day 0-30) follow-up period
measure: Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs)
timeFrame: During the Active Phase (from Day 0 to Day 30 after final vaccine dose for each subject)
measure: Number of Subjects With SAEs, NCIs and MSEs
timeFrame: During the Extended Safety Follow-up (ESFU) Phase (from Day 30 to 6 months after final vaccine dose)
Other outcomes:
Locations:
city: Centennial
country: United States
facility: GSK Investigational Site
state: Colorado
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: GSK Investigational Site
state: Michigan
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: North Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Stony Brook
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: University Heights
country: United States
facility: GSK Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Vancouver
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.