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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00158756
First received: September 8, 2005
Last updated: April 14, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Hepatitis B Biological: Tritanrix™-HepB Biological: Rotarix™ Biological: Zilbrix™ Biological: Triple Antigen™ Biological: Engerix™-B Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies [ Time Frame: 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:
  • Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA [ Time Frame: 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 [ Time Frame: 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).

  • Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values [ Time Frame: 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 Subjects With Vaccine Response to BPT Antigen [ Time Frame: 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.

  • Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values [ Time Frame: 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 [ Time Frame: 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 Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) [ Time Frame: 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

  • Concentrations of Anti-HBs Antibodies [ Time Frame: 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-DT Antibodies [ Time Frame: At one month post dose 3 [PIII(M4)] ]
    Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.

  • Concentrations of Anti-T Antibodies [ Time Frame: 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 [ Time Frame: At one month post dose 3 [PIII(M4)] ]
    Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.

  • Concentrations of Anti-RV Antibodies [ Time Frame: At 2.5 months post dose 2 of Rotarix [PIII(M4)] ]
    Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.

  • Anti-Polio Type 1, 2, 3 Antibody Titers [ Time Frame: 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 Subjects With Solicited Local Symptoms [ Time Frame: 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).

  • Number of Subjects With Any Solicited General Symptoms [ Time Frame: 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 Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: 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) [ Time Frame: 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.


Enrollment: 308
Actual Study Start Date: September 12, 2005
Study Completion Date: November 23, 2006
Primary Completion Date: November 1, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tritanrix™-HepB+Rotarix™ Group
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.
Biological: Tritanrix™-HepB
GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.
Other Name: DTPw-HBV
Biological: Rotarix™
GSK Biologicals' live attenuated human rotavirus vaccine
Other Name: HRV vaccine
Experimental: Tritanrix™-HepB+Placebo Group
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.
Biological: Tritanrix™-HepB
GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.
Other Name: DTPw-HBV
Drug: Placebo
Placebo for the Rotarix™ vaccine
Active Comparator: Zilbrix™+Rotarix™ Group
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.
Biological: Rotarix™
GSK Biologicals' live attenuated human rotavirus vaccine
Other Name: HRV vaccine
Biological: Zilbrix™
GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine
Other Name: DTPw-HBV Kft
Active Comparator: Zilbrix™+Placebo Group
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.
Biological: Zilbrix™
GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine
Other Name: DTPw-HBV Kft
Drug: Placebo
Placebo for the Rotarix™ vaccine
Active Comparator: Triple Antigen™+Engerix™-B Group
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.
Biological: Triple Antigen™
Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.
Other Name: DTPwcsl vaccine
Biological: Engerix™-B
GSK Biologicals' hepatitis B vaccine
Other Name: HBV vaccine

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

Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158756

Locations
Russian Federation
GSK Investigational Site
Barnaul, Russian Federation, 656049
GSK Investigational Site
Ekaterinburg, Russian Federation, 620003
GSK Investigational Site
Ivanteevka Moscow region, Russian Federation, 141280
GSK Investigational Site
Krasnoyarsk, Russian Federation, 660027
GSK Investigational Site
Moscow, Russian Federation, 119991
GSK Investigational Site
Moscow, Russian Federation, 129347
GSK Investigational Site
Samara, Russian Federation, 443021
GSK Investigational Site
St Petersburg, Russian Federation, 197022
GSK Investigational Site
Tomsk, Russian Federation, 634 050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 104021
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 104021
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 104021
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 104021
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 104021
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 104021
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00158756     History of Changes
Other Study ID Numbers: 104021
Study First Received: September 8, 2005
Results First Received: December 20, 2016
Last Updated: April 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Diphtheria
Pertussis
Prophylaxis
Hepatitis B diseases
Tetanus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017