GSK: Protocol Summary for 104021

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Protocol Summary for 104021

Protocol Summary
Protocol Id:	104021
Secondary Ids:
Title:	Assess immunogenicity & reactogenicity of 2 formulations of GSK’s DTPw-HBV vaccines vs concomitant admn of CSL’s DTPw & GSK’s HBV vaccine, co-admnd with GSK’s rotavirus vaccine, to infants at 3, 4½ & 6 mths, after birth dose of HBV vaccine
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Russia: Pharmacological Committee, Ministry of Health
Collaborators:
Brief Summary:	To compare the two formulations of GSK Biologicals’ DTPw-HBV vaccine to concomitant administration of CSL’s DTPw vaccine and GSK Biologicals’ HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.
Detailed Description:	Randomized study with five groups to receive one of the following vaccination regimens: One of the two formulations of GSK Biologicals’ DTPw-HBV + GSK Biologicals’ HRV One of the two formulations of GSK Biologicals’ DTPw-HBV + Placebo CSL’s DTPw + GSK Biologicals’ HBV
Record Verification Date:	February 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	September 2005
Study Completion Date:	November 2006
Study Completion Date Type:	Actual
Primary Completion Date:	November 2006
Primary Completion Date Type:	Actual
Primary Purpose:	prevention
Allocation:	Randomized
Masking:	Open Label
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):
Primary Outcomes:	One month after the third dose of the primary vaccination course, anti-diphtheria antibody concentration.
Secondary Outcomes:	Occurrence of serious adverse events over the full course of the study. Occurrence of unsolicited symptoms during the specific follow-up period after each dose. Occurrence of solicited symptoms during the specific follow-up period after each dose. One month after the third dose of the primary vaccination course: antibody concentrations or titres against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B, rotavirus and poliovirus antigens)
Conditions:	Infant Healthy Subjects
Keywords:	Diphtheria Pertussis Prophylaxis Hepatitis B diseases Tetanus
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion criteria: •Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol. •Administration of one dose of hepatitis B vaccine at birth. •A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination. •Free of obvious health problems as established by medical history and clinical examination before entering into the study. Exclusion criteria: •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. •Chronic administration of immunosuppressants or other immune-modifying drugs since birth. •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine. •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required) •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Gender:	Both
Minimum Age:	3 Weeks
Maximum Age:	4 Months
Enrollment:	307
Enrollment Type:	Actual
Healthy Volunteers?:	yes
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Russian Federation (click to view all sites in Russian Federation) GSK Investigational Site Moscow, 119991; COMPLETED; GSK Investigational Site Ivanteevka Moscow region, 141280; COMPLETED; GSK Investigational Site Samara, 443021; COMPLETED; GSK Investigational Site Moscow, 129347; COMPLETED; GSK Investigational Site Krasnoyarsk, 660027; COMPLETED; GSK Investigational Site Ekaterinburg, 620003; COMPLETED; GSK Investigational Site Barnaul, 656049; COMPLETED; GSK Investigational Site Tomsk, 634 050; COMPLETED; GSK Investigational Site St Petersburg, 197022; COMPLETED;

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Protocol Summary for 104021