Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants

Hepatitis B Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158756
• Other study ID #: 104021
• Status: Completed
• Phase: Phase 3
• Start date: September 12, 2005
• Est. completion date: November 23, 2006

Study information

• Verified date: April 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: November 23, 2006
• Est. primary completion date: November 1, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Tritanrix™-HepB
GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.
• Rotarix™
GSK Biologicals' live attenuated human rotavirus vaccine
• Zilbrix™
GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine
• Triple Antigen™
Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.
• Engerix™-B
GSK Biologicals' hepatitis B vaccine

Drug:
• Placebo
Placebo for the Rotarix™ vaccine

Locations

Country	Name	City	State
Russian Federation	GSK Investigational Site	Barnaul
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Ivanteevka Moscow Region
Russian Federation	GSK Investigational Site	Krasnoyarsk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	St Petersburg
Russian Federation	GSK Investigational Site	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies	Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (=) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or = 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.	At one month post dose 3 [PIII(M4)]
Secondary	Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA	A seroprotected subject is a vaccinated subject with concentrations = 0.1 IU/mL.	At one month post dose 3 [PIII(M4)]
Secondary	Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies	A seroprotected subject was defined as a vaccinated subject with antibody concentrations = 10 milli-international units per millilitre (mIU/mL).	At one most post dose 3 [PIII(M4)]
Secondary	Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations = the Established Cut-off Values	A seropositive subject was defined as a subject with Anti-BPT antibody concentrations = 15 ELISA units per millilitre (EL.U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).	At one month post dose 3 [PIII(M4)]
Secondary	Number of Subjects With Vaccine Response to BPT Antigen	Vaccine response (VR) was defined as the appearance of antibodies in subjects seronegative at pre-vaccination and antibody concentrations = the cut-off values post-vaccination in subjects who were seropositive at pre-vaccination.	At one month post dose 3 [PIII(M4)]
Secondary	Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values	A seropositive subject was defined as a subject with anti-RV antibody concentrations = 20 units per millilitre (U/mL).	At 2.5 months after dose 2 of Rotarix [PIII(M4)]
Secondary	Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen	A seroprotected subject was defined as a vaccinated subject with anti-T antibody concentrations = the cut-off value of 0.1 international units per millilitre (IU/mL).	At one month post dose 3 [PIII(M4)]
Secondary	Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)	A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers = 8	At one month post dose 3 [PIII(M4)]
Secondary	Concentrations of Anti-HBs Antibodies	Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.	At one month post dose 3 [PIII(M4)]
Secondary	Concentrations of Anti-DT Antibodies	Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.	At one month post dose 3 [PIII(M4)]
Secondary	Concentrations of Anti-T Antibodies	Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).	At one month post dose 3 [PIII(M4)]
Secondary	Concentrations of Anti-BPT Antibodies	Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.	At one month post dose 3 [PIII(M4)]
Secondary	Concentrations of Anti-RV Antibodies	Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.	At 2.5 months post dose 2 of Rotarix [PIII(M4)]
Secondary	Anti-Polio Type 1, 2, 3 Antibody Titers	Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).	At one month post dose 3 [PIII(M4)]
Secondary	Number of Subjects With Solicited Local Symptoms	Solicited local symptoms were pain, redness and swelling. Any = occurence of symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 30 millimeters (mm).	During the 8-Day (Days 0-7) follow-up period
Secondary	Number of Subjects With Any Solicited General Symptoms	Assessed solicited general symptoms were diarrhea, drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability, loss of appetite [loss of appet.] and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Grade 3 loss of appetite = symptoms that prevents eating. Grade 3 diarrhea = = 6 looser than normal stools per (/) day. Grade 3 vomiting = = 3 episodes of vomiting/day.	During the 8-day period (Days 0-7) post-vaccination
Secondary	Number of Subjects With Unsolicited Adverse Events (AEs)	Number of subjects with any unsolicited adverse events (AEs); An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	During the 31-day (Days 0-30) follow-up period
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From Month 0 to Month 4

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