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

GlaxoSmithKline308 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

308

Conditions

Hepatitis B

Interventions

Tritanrix™-HepBBIOLOGICAL

GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.

Rotarix™BIOLOGICAL

GSK Biologicals' live attenuated human rotavirus vaccine

Zilbrix™BIOLOGICAL

GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine

Eligibility

Sex: ALLMin age: 3 WeeksMax age: 4 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (9)

GSK Investigational Site

Barnaul, Russia

GSK Investigational Site

Ivanteevka Moscow Region, Russia

GSK Investigational Site

Krasnoyarsk, Russia

GSK Investigational Site

Moscow, Russia

Outcomes

Primary Outcomes

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.

Time frame: At one month post dose 3 [PIII(M4)]

Secondary Outcomes

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.

Time frame: At one month post dose 3 [PIII(M4)]

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).

Time frame: At one most post dose 3 [PIII(M4)]

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).

Time frame: At one month post dose 3 [PIII(M4)]

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.

Time frame: At one month post dose 3 [PIII(M4)]

Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values

Data from ClinicalTrials.gov

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Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.

Engerix™-BBIOLOGICAL

GSK Biologicals' hepatitis B vaccine

PlaceboDRUG

Placebo for the Rotarix™ vaccine

GSK Investigational Site

Moscow, Russia

GSK Investigational Site

Saint Petersburg, Russia

GSK Investigational Site

Samara, Russia

GSK Investigational Site

Tomsk, Russia

GSK Investigational Site

Yekaterinburg, Russia

A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL).

Time frame: At 2.5 months after dose 2 of Rotarix [PIII(M4)]

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).

Time frame: At one month post dose 3 [PIII(M4)]

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

Time frame: At one month post dose 3 [PIII(M4)]

Concentrations of Anti-HBs Antibodies

Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.

Time frame: At one month post dose 3 [PIII(M4)]

Concentrations of Anti-DT Antibodies

Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.

Time frame: At one month post dose 3 [PIII(M4)]

Concentrations of Anti-T Antibodies

Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).

Time frame: At one month post dose 3 [PIII(M4)]

Concentrations of Anti-BPT Antibodies

Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.

Time frame: At one month post dose 3 [PIII(M4)]

Concentrations of Anti-RV Antibodies

Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.

Time frame: At 2.5 months post dose 2 of Rotarix [PIII(M4)]

Anti-Polio Type 1, 2, 3 Antibody Titers

Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).

Time frame: At one month post dose 3 [PIII(M4)]

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).

Time frame: During the 8-Day (Days 0-7) follow-up period

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.

Time frame: During the 8-day period (Days 0-7) post-vaccination

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.

Time frame: During the 31-day (Days 0-30) follow-up period

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.

Time frame: From Month 0 to Month 4