Clinical trial NCT00473668: Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Whole Cell Pertussis
Haemophilus Influenzae Type b
Tetanus
Diphtheria
Hepatitis B
Keywords: Hepatitis B
Tetanus
Diphtheria
Pertussis
Haemophilus influenzae type b Vaccines
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-05-15
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

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 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.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens
timeFrame: At Month 3
Secondary outcomes:
measure: Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
timeFrame: At Month 3
measure: Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen
timeFrame: At Month 3
measure: Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off
timeFrame: At Month 3
measure: Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens
timeFrame: At Month 3
measure: Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen
timeFrame: At Month 3
measure: Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen
timeFrame: At Month 3
measure: Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens
timeFrame: At Month 3
measure: Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens
timeFrame: At Month 3
measure: Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs)
timeFrame: At Month 3
measure: Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen
timeFrame: At Month 3
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Day 0-3) follow-up period post-vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Day 0-3) follow-up period post-vaccination
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Day 0-30) follow-up period post-vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Day 0-Month 3)
Other outcomes:
Locations:
city: Bangalore
country: India
facility: GSK Investigational Site
city: Kolkotta
country: India
facility: GSK Investigational Site
city: Varanasi
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.