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
1 other identifier
interventional
468
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2003
Typical duration for phase_3
22 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
November 11, 2003
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2007
CompletedResults Posted
Study results publicly available
July 24, 2009
CompletedAugust 20, 2018
January 1, 2017
4.1 years
September 15, 2005
December 2, 2008
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
31 days following the second dose of Havrix™
Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects
Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.
31 days following the administration of Infanrix™ and ActHIB
Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)
Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.
31 days following the administration of Infanrix™ and ActHIB
Secondary Outcomes (11)
Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)
31 days following the administration of Infanrix™ and ActHIB
Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)
31 days following the administration of Infanrix™ and ActHIB
Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)
31 days following the administration of Infanrix™ and ActHIB
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix
31 days following the first dose of Havrix™
Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix
31 days following the first dose of Havrix™
- +6 more secondary outcomes
Study Arms (3)
Havrix Group
ACTIVE COMPARATORSubjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
Infanrix + ActHIB→Havrix Group
EXPERIMENTALSubjects 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.
Havrix + Infanrix + ActHIB Group
ACTIVE COMPARATORSubjects 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.
Interventions
2 intramuscular injections, 6 months apart
1 intramuscular injection
1 intramuscular injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (22)
GSK Investigational Site
Phoenix, Arizona, 85029, United States
GSK Investigational Site
Oakland, California, 94612, United States
GSK Investigational Site
San Ramon, California, 94583, United States
GSK Investigational Site
Wilmington, Delaware, 19810, United States
GSK Investigational Site
Pembroke Pines, Florida, 33027, United States
GSK Investigational Site
Martinez, Georgia, 30907, United States
GSK Investigational Site
Waterloo, Iowa, 50702, United States
GSK Investigational Site
Bossier City, Louisiana, 71111, United States
GSK Investigational Site
Long Branch, New Jersey, 07740, United States
GSK Investigational Site
Ithaca, New York, 14850, United States
GSK Investigational Site
Bismarck, North Dakota, 58501, United States
GSK Investigational Site
Youngstown, Ohio, 44501, United States
GSK Investigational Site
Bellevue, Pennsylvania, 15202, United States
GSK Investigational Site
Hershey, Pennsylvania, 17033, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Charleston, South Carolina, 29425, United States
GSK Investigational Site
Beaumont, Texas, 77701, United States
GSK Investigational Site
Dallas, Texas, 75235, United States
GSK Investigational Site
Danville, Virginia, 24549, United States
GSK Investigational Site
Mechanicsville, Virginia, 23111, United States
GSK Investigational Site
La Crosse, Wisconsin, 54601, United States
Related Publications (1)
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.
PMID: 21494175BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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 15, 2005
First Posted
September 20, 2005
Study Start
November 11, 2003
Primary Completion
December 3, 2007
Study Completion
December 3, 2007
Last Updated
August 20, 2018
Results First Posted
July 24, 2009
Record last verified: 2017-01
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.