Clinical trial NCT00197236: Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
Official title: Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With GSK Biologicals' DTaP Vaccine (Infanrix™) and Aventis Pasteur's Haemophilus b Conjugate Vaccine (ActHIB) in Healthy Children 15 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis A
Keywords: Hepatitis A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 468
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 immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description: An open, controlled comparison of Havrix™ administered alone or with Infanrix™ and ActHIB. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + Infanrix™ and ActHIB and 3) Infanrix™ and ActHIB followed by Havrix™ one month later.

Eligibility criteria: Inclusion Criteria:

* Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol
* A male or female child 12 or 13 months of age at the time of entry into the Enrolment Phase,
* Subjects must have previously received three doses each of DTaP and Hib vaccines during the first year of life. The three doses of DTaP vaccine must have been administered as either Infanrix™ or Pediarix™ and the three doses of Hib vaccine must have been administered as ActHIB™, HibTITER™, OmniHIB™.
* Subjects who, at 15 months of age, will have had at least six months elapse since their third dose of Infanrix™ or Pediarix™,
* Written informed consent obtained from the parents or guardian of the subject,
* Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study, and
* Parents/guardian of the subject must have a telephone or be able to be contacted by telephone.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 31 days preceding the first dose of study vaccine, or planned use during the study period,
* Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period.
* Planned administration or administration of any vaccine not foreseen by the study protocol during the period 42 days before and 31 days after each dose of study vaccine(s).
* Previous vaccination against DTaP using a commercially-available brand other than Infanrix™ or Pediarix™ or against Hib using a commercially-available brand other than ActHIB™, HibTITER™ or OmniHIB™.
* Previous vaccination with more than three doses of DTaP-containing vaccines or more than three doses of Hib-containing vaccines.
* Previous vaccination against hepatitis A,
* History or known exposure to hepatitis A,
* History of diphtheria, tetanus, pertussis and/or Haemophilus influenza type b,
* Known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenza type b within 31 days prior to the start of the study,
* History of non-response to any vaccine in the current routine immunization schedule,
* 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™, Infanrix™ or ActHIB™ including 2-phenoxyethanol, neomycin and gelatin,
* History of hypersensitivity/allergic reaction to latex
* Major congenital defects or serious chronic illness,
* History of any neurologic disorder
* Acute disease 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, i.e., the Enrolment Phase, the Active Phase and the Extended Safety Follow-up Phase

Primary outcomes:
measure: Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix
timeFrame: 31 days following the second dose of Havrix™
measure: Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects
timeFrame: 31 days following the administration of Infanrix™ and ActHIB
measure: Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)
timeFrame: 31 days following the administration of Infanrix™ and ActHIB
Secondary outcomes:
measure: Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)
timeFrame: 31 days following the administration of Infanrix™ and ActHIB
measure: Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)
timeFrame: 31 days following the administration of Infanrix™ and ActHIB
measure: Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)
timeFrame: 31 days following the administration of Infanrix™ and ActHIB
measure: Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix
timeFrame: 31 days following the first dose of Havrix™
measure: Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix
timeFrame: 31 days following the first dose of Havrix™
measure: Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix
timeFrame: 31 days following the second dose of Havrix™
measure: Number of Subjects With Vaccine Response to Havrix™.
timeFrame: 31 days following the second dose
measure: Number of Subjects Reporting Solicited Local Adverse Events (AEs)
timeFrame: 4-day period following each dose of study vaccine(s)
measure: Number of Subjects Reporting Solicited General Adverse Events (AEs)
timeFrame: 4-day period following each dose of study vaccine(s)
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: 31-day period following each dose of study vaccine(s)
measure: Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events
timeFrame: Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Oakland
country: United States
facility: GSK Investigational Site
state: California
city: San Ramon
country: United States
facility: GSK Investigational Site
state: California
city: Wilmington
country: United States
facility: GSK Investigational Site
state: Delaware
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Martinez
country: United States
facility: GSK Investigational Site
state: Georgia
city: Waterloo
country: United States
facility: GSK Investigational Site
state: Iowa
city: Bossier City
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Long Branch
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Ithaca
country: United States
facility: GSK Investigational Site
state: New York
city: Bismarck
country: United States
facility: GSK Investigational Site
state: North Dakota
city: Youngstown
country: United States
facility: GSK Investigational Site
state: Ohio
city: Bellevue
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Beaumont
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Danville
country: United States
facility: GSK Investigational Site
state: Virginia
city: Mechanicsville
country: United States
facility: GSK Investigational Site
state: Virginia
city: La Crosse
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Trofa AF, Klein NP, Paul IM, Michaels MG, Goessler M, Chandrasekaran V, Blatter M. Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with Diphtheria-tetanus-acellular pertussis and haemophilus influenzae type B vaccines in children 15 months of age. Pediatr Infect Dis J. 2011 Sep;30(9):e164-9. doi: 10.1097/INF.0b013e31821b8a7d.