Full Text View
Tabular View
Study Results
Related Studies
Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
This study has been completed.
Study NCT00197236   Information provided by GlaxoSmithKline
First Received: September 15, 2005   Last Updated: July 24, 2009   History of Changes

September 15, 2005
July 24, 2009
November 2003
December 2007   (final data collection date for primary outcome measure)
  • Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix [ Time Frame: 31 days following the second dose of Havrix™ ] [ Designated as safety issue: No ]
  • Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ] [ Designated as safety issue: No ]
  • Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN) [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ] [ Designated as safety issue: No ]
  • Immune response for Havrix following the second dose of Havrix in both the Havrix group and the Havrix + Infanrix and ActHIB group.
  • Immune response for DTaP and Hib following vaccination with Infanrix and ActHIB in both the Havrix + Infanrix and ActHIB group and the Infanrix and ActHIB followed by Havrix group.
Complete list of historical versions of study NCT00197236 on ClinicalTrials.gov Archive Site
  • Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC) [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ] [ Designated as safety issue: No ]
  • Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC) [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ] [ Designated as safety issue: No ]
  • Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP) [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ] [ Designated as safety issue: No ]
  • Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix [ Time Frame: 31 days following the first dose of Havrix™ ] [ Designated as safety issue: No ]
  • Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix [ Time Frame: 31 days following the first dose of Havrix™ ] [ Designated as safety issue: No ]
  • Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix [ Time Frame: 31 days following the second dose of Havrix™ ] [ Designated as safety issue: No ]
  • Number of Subjects With Vaccine Response to Havrix™. [ Time Frame: 31 days following the second dose ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Solicited Local Adverse Events (AEs) [ Time Frame: 4-day period following each dose of study vaccine(s) ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Solicited General Adverse Events (AEs) [ Time Frame: 4-day period following each dose of study vaccine(s) ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: 31-day period following each dose of study vaccine(s) ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events [ Time Frame: Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase. ] [ Designated as safety issue: No ]
Immune response for Havrix following the first dose of Havrix in all groups. The other secondary outcome measure is safety of the study vaccines.
 
Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
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

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.

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.

Phase III
Interventional
Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Hepatitis A
  • Biological: Havrix™
  • Biological: Infanrix™
  • Biological: ActHIB™
  • Active Comparator: Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
  • Experimental: Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
  • Active Comparator: Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
468
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
12 Months to 13 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00197236
Study Director, GSK
208109/232
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2009

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