Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
- Conditions
- Hepatitis B
- Interventions
- Biological: Rotarix™Biological: Tritanrix™-HepBBiological: Triple Antigen™Drug: PlaceboBiological: Engerix™-BBiological: Zilbrix™
- Registration Number
- NCT00158756
- Lead Sponsor
- GlaxoSmithKline
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 308
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zilbrix™+Rotarix™ Group Rotarix™ Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age. Tritanrix™-HepB+Rotarix™ Group Tritanrix™-HepB Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age. Tritanrix™-HepB+Placebo Group Tritanrix™-HepB Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age. Tritanrix™-HepB+Rotarix™ Group Rotarix™ Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age. Zilbrix™+Placebo Group Placebo Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age. Triple Antigen™+Engerix™-B Group Triple Antigen™ Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively. Tritanrix™-HepB+Placebo Group Placebo Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age. Triple Antigen™+Engerix™-B Group Engerix™-B Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively. Zilbrix™+Rotarix™ Group Zilbrix™ Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age. Zilbrix™+Placebo Group Zilbrix™ Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
- Primary Outcome Measures
Name Time Method Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies At one month post dose 3 [PIII(M4)] 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.
- Secondary Outcome Measures
Name Time Method Number of Subjects With Vaccine Response to BPT Antigen At one month post dose 3 [PIII(M4)] 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.
Concentrations of Anti-RV Antibodies At 2.5 months post dose 2 of Rotarix [PIII(M4)] Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.
Number of Subjects With Any Solicited General Symptoms During the 8-day period (Days 0-7) post-vaccination 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.
Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values At one month post dose 3 [PIII(M4)] 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).
Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) At one month post dose 3 [PIII(M4)] A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers ≥ 8
Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA At one month post dose 3 [PIII(M4)] A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL.
Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies At one most post dose 3 [PIII(M4)] A seroprotected subject was defined as a vaccinated subject with antibody concentrations ≥ 10 milli-international units per millilitre (mIU/mL).
Concentrations of Anti-DT Antibodies At one month post dose 3 [PIII(M4)] Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.
Anti-Polio Type 1, 2, 3 Antibody Titers At one month post dose 3 [PIII(M4)] Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).
Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values At 2.5 months after dose 2 of Rotarix [PIII(M4)] A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL).
Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen At one month post dose 3 [PIII(M4)] 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).
Number of Subjects With Solicited Local Symptoms During the 8-Day (Days 0-7) follow-up period 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).
Concentrations of Anti-HBs Antibodies At one month post dose 3 [PIII(M4)] Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.
Concentrations of Anti-T Antibodies At one month post dose 3 [PIII(M4)] Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).
Concentrations of Anti-BPT Antibodies At one month post dose 3 [PIII(M4)] Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.
Number of Subjects With Unsolicited Adverse Events (AEs) During the 31-day (Days 0-30) follow-up period 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.Number of Subjects With Serious Adverse Events (SAEs) From Month 0 to Month 4 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.
Trial Locations
- Locations (1)
GSK Investigational Site
🇷🇺Tomsk, Russian Federation