Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib
Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals' DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals' DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.
1 other identifier
interventional
148
2 countries
2
Brief Summary
This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. 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 P25-P50 for phase_3
Started Jun 2006
Shorter than P25 for phase_3
2 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
First Submitted
Initial submission to the registry
May 31, 2006
CompletedFirst Posted
Study publicly available on registry
June 1, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedSeptember 28, 2016
September 1, 2016
4 months
May 31, 2006
September 27, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration
One month after the booster dose
Anti-hepatitis B surface antigen (HBs) antibody concentration
One month after the booster dose
Anti-diphtheria antibody concentration
One month after the booster dose
Anti-tetanus antibody concentration
One month after the booster dose
Secondary Outcomes (9)
Anti-Bordetella pertussis (BPT) antibody concentration
One month after the booster dose
Anti-PRP antibody concentration
Prior to the booster dose
Anti-HBs antibody concentration
Prior to the booster dose
Anti-diphtheria antibody concentration
Prior to the booster dose
Anti-tetanus antibody concentration
Prior to the booster dose
- +4 more secondary outcomes
Study Arms (2)
Group A
EXPERIMENTALGroup B
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female toddler, 18 to 24 months of age at the time of booster vaccination, who completed the three-dose primary vaccination course in the 101223 study.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
You may not qualify if:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of the booster vaccine dose, with the exception of oral polio vaccine (OPV).
- Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study.
- History of diphtheria, tetanus, pertussis, hepatitis B and Hib disease.
- Known exposure to diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products during the study period.
- Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
- One of the following adverse events that constitute absolute contraindications to further administration of DTP vaccine, having occurred after previous administration of DTPw vaccine.
- Known hypersensitivity to any component of the vaccine, or having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or HB vaccines.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Capital Federal, Buenos Aires, 1425, Argentina
GSK Investigational Site
León, Nicaragua
Related Publications (1)
Espinoza F, Tregnaghi M, Gentile A, Abarca K, Casellas J, Collard A, Lefevre I, Jacquet JM. Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial. BMC Infect Dis. 2010 Oct 15;10:297. doi: 10.1186/1471-2334-10-297.
PMID: 20950456DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
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
May 31, 2006
First Posted
June 1, 2006
Study Start
June 1, 2006
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
September 28, 2016
Record last verified: 2016-09
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.