Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib
Non-inferiority of One Formulation of GSK Biologicals' DTPw-HBV/Hib to 2 Formulations of GSK Biologicals' DTPw-HBV/Hib With Respect to the Immune Response to the PRP Antigen, When Administered to Healthy Infants at 6, 10, 14 Weeks of Age
1 other identifier
interventional
300
1 country
3
Brief Summary
The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. 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 Jun 2007
Shorter than P25 for phase_3
3 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 14, 2007
CompletedFirst Posted
Study publicly available on registry
May 15, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2008
CompletedResults Posted
Study results publicly available
August 18, 2017
CompletedAugust 18, 2017
March 1, 2017
8 months
May 14, 2007
March 21, 2017
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens
A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).
At Month 3
Secondary Outcomes (14)
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
At Month 3
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen
At Month 3
Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off
At Month 3
Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens
At Month 3
Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen
At Month 3
- +9 more secondary outcomes
Study Arms (3)
TRITANRIX-HEPB/HIBERIX KFT. GROUP
EXPERIMENTALSubjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
TRITANRIX-HEPB/HIBERIX LD GROUP
ACTIVE COMPARATORSubjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
TRITANRIX-HEPB/HIBERIX HD GROUP
ACTIVE COMPARATORSubjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
Interventions
Intramuscular injection, 1 dose
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.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Administration of one dose of hepatitis B vaccine at birth
You may not qualify if:
- 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 with the exception of OPV.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose, (with the exception of OPV).
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- Hepatitis B vaccine received after the first week of life.
- Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B (except hepatitis B at birth).
- History of diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B diseases.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- A family history of congenital or hereditary immunodeficiency.
- 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.
- Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (3)
GSK Investigational Site
Bangalore, 560034, India
GSK Investigational Site
Kolkotta, 700072, India
GSK Investigational Site
Varanasi, 221005, India
Related Publications (1)
Chatterjee S, Rego SJ, D'Souza F, Bhatia BD, Collard A, Datta SK, Jacquet JM. The immunogenicity and safety of a reduced PRP-content DTPw-HBV/Hib vaccine when administered according to the accelerated EPI schedule. BMC Infect Dis. 2010 Oct 15;10:298. doi: 10.1186/1471-2334-10-298.
PMID: 20950457BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition 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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2007
First Posted
May 15, 2007
Study Start
June 1, 2007
Primary Completion
January 30, 2008
Study Completion
January 30, 2008
Last Updated
August 18, 2017
Results First Posted
August 18, 2017
Record last verified: 2017-03
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.