Clinical trial NCT00158756: Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
Official title: A Phase III, Partially Blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB and GSK Biologicals Kft's DTPw-HBV Vaccines as Compared to Concomitant Administration of Commonwealth Serum Laboratory's (CSL's) DTPw (Triple Antigen™) and GSK Biologicals' HBV (Engerix™-B), When Co-administered With GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, to Healthy Infants at 3, 4½ and 6 Months of Age, After a Birth Dose of Hepatitis B Vaccine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Diphtheria
Pertussis
Prophylaxis
Hepatitis B diseases
Tetanus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 308
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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.

Primary outcomes:
measure: Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies
timeFrame: At one month post dose 3 [PIII(M4)]
Secondary outcomes:
measure: Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA
timeFrame: At one month post dose 3 [PIII(M4)]
measure: Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies
timeFrame: At one most post dose 3 [PIII(M4)]
measure: Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values
timeFrame: At one month post dose 3 [PIII(M4)]
measure: Number of Subjects With Vaccine Response to BPT Antigen
timeFrame: At one month post dose 3 [PIII(M4)]
measure: Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values
timeFrame: At 2.5 months after dose 2 of Rotarix [PIII(M4)]
measure: Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen
timeFrame: At one month post dose 3 [PIII(M4)]
measure: Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)
timeFrame: At one month post dose 3 [PIII(M4)]
measure: Concentrations of Anti-HBs Antibodies
timeFrame: At one month post dose 3 [PIII(M4)]
measure: Concentrations of Anti-DT Antibodies
timeFrame: At one month post dose 3 [PIII(M4)]
measure: Concentrations of Anti-T Antibodies
timeFrame: At one month post dose 3 [PIII(M4)]
measure: Concentrations of Anti-BPT Antibodies
timeFrame: At one month post dose 3 [PIII(M4)]
measure: Concentrations of Anti-RV Antibodies
timeFrame: At 2.5 months post dose 2 of Rotarix [PIII(M4)]
measure: Anti-Polio Type 1, 2, 3 Antibody Titers
timeFrame: At one month post dose 3 [PIII(M4)]
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 8-Day (Days 0-7) follow-up period
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During the 8-day period (Days 0-7) post-vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) follow-up period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Month 0 to Month 4
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Ivanteevka Moscow Region
country: Russian Federation
facility: GSK Investigational Site
city: Krasnoyarsk
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Samara
country: Russian Federation
facility: GSK Investigational Site
city: St Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: