Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™
A Phase II, Double-blind, Randomized Study to Compare the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB/Hib2.5 to GSK Biologicals' Tritanrix™-HepB/Hiberix™ When Administered as a Three-dose Primary Vaccination Course to Healthy Infants at 6, 10 and 14 Weeks of Age. A Dose of Unconjugated Hib Vaccine (Plain PRP Booster) Will be Administered at the Age of 10 Months to 50% of the Subjects
2 other identifiers
interventional
192
1 country
1
Brief Summary
In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5). The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive Tritanrix™-HepB/Hiberix™. Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects 50% were randomised to participate in the PRP challenge study (208108/092) (open), and all subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2003
Shorter than P25 for phase_2
1 active site
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
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 2, 2010
CompletedFirst Posted
Study publicly available on registry
February 3, 2010
CompletedSeptember 9, 2016
September 1, 2016
5 months
February 2, 2010
September 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
anti-PRP antibody concentration above a protocol defined cut-off value.
One month after the third dose of the primary vaccination course.
Secondary Outcomes (11)
anti-HBs antibody concentration
One month after the third dose of the primary vaccination course
anti-PRP antibody concentration
One month after the third dose of the primary vaccination course
anti-tetanus antibody concentration
One month after the third dose of the primary vaccination course
anti-diphtheria antibody concentration
One month after the third dose of the primary vaccination course
anti-Bordetella pertussis (BPT) antibody concentration
One month after the third dose of the primary vaccination course
- +6 more secondary outcomes
Study Arms (2)
Group A
EXPERIMENTALGroup B
ACTIVE COMPARATORInterventions
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
One dose as intramuscular injection at 10 months of age
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 between, and including, 6 and 8 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks.
- Born to a mother proven seronegative for HBsAg.
You may not qualify if:
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine, with the exception of oral polio vaccine (OPV).
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- Use of any investigational or non-registered 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.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B and/or Hib.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Hib disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or history.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
City of Muntinlupa, 1781, Philippines
Related Publications (1)
Gatchalian SR, Ramakrishnan G, Bock HL, Lefevre I, Jacquet JM. Immunogenicity, reactogenicity and safety of three-dose primary and booster vaccination with combined diphtheria-tetanus-whole-cell pertussis-hepatitis B-reduced antigen content Haemophilus influenzae type b vaccine in Filipino children. Hum Vaccin. 2010 Aug;6(8):664-72. doi: 10.4161/hv.6.8.12155.
PMID: 20657177DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2010
First Posted
February 3, 2010
Study Start
August 1, 2003
Primary Completion
January 1, 2004
Study Completion
August 1, 2004
Last Updated
September 9, 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.