Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib

Browse trials for

• Hepatitis B 1,656
• Whooping Cough 238
• Tetanus 198
• Diphtheria 265
• Hepatitis 3,380

Keywords

• Hepatitis B
• Tetanus
• Diphtheria
• Pertussis
• Haemophilus influenzae type b Vaccines

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 300 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• Experimental
  TRITANRIX-HEPB/HIBERIX KFT. GROUP

  Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.

  Biological: Zilbrix-Hib

• Active comparator
  TRITANRIX-HEPB/HIBERIX LD GROUP

  Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.

  Biological: Tritanrix™-HepB/ Hiberix™

• Active comparator
  TRITANRIX-HEPB/HIBERIX HD GROUP

  Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.

  Biological: Tritanrix™-HepB/ Hiberix™

Interventions

• BiologicalZilbrix-Hib

  Intramuscular injection, 1 dose

• BiologicalTritanrix™-HepB/ Hiberix™

  Intramuscular injection, 1 dose

Primary outcomes

1. Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens

   A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).

   Time frame: At Month 3

Secondary outcomes

1. Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)

   A seroprotected subject is defined as a vaccinated subject with anti-hepatitis B antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).

   Time frame: At Month 3

2. Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen

   A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Seroprotection was assesed via enzyme-linked immunosorbent assay (ELISA).

   Time frame: At Month 3

3. Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off

   Seroprotection cut-off values assessed were greater than or equal to (≥) 0.016 international units per milliliter (IU/mL) in the sera of subjects seronegative before vaccination. Concentrations were assessed via neutralization assay on Vero cells.

   Time frame: At Month 3

4. Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens

   Seropositivity was defined as antibody concentrations greater than or equal to (≥) 1 microgram/milliliter (µg/mL).

   Time frame: At Month 3

5. Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen

   A seropositive subject was defined as a vaccinated subject with anti-BPT antibody concentration greater than or equal to (≥) 15 ELISA units (EL.U) per milliliter (EL.U/mL).

   Time frame: At Month 3

6. Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen

   Vaccine response was defined as: for initially seronegative subjects, antibody concentration greater than or equal to (≥) 15 EL.U/mL; and for initially seropositive subjects, antibody concentration ≥ 1 fold the pre-vaccination antibody concentration.

   Time frame: At Month 3

7. Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens

   Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).

   Time frame: At Month 3

8. Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens

   Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

   Time frame: At Month 3

9. Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs)

   Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

   Time frame: At Month 3

10. Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen

    Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).

    Time frame: At Month 3

11. Number of Subjects With Any and Grade 3 Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

    Time frame: During the 4-day (Day 0-3) follow-up period post-vaccination

12. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

    Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade. Grade 3 Irritability= crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness/Loss of appetite= Drowsiness/Loss of appetite that prevented normal activity. Grade 3 fever = fever above (\>) 39.5°C. Related = symptom assessed by the investigator as related to the vaccination.

    Time frame: During the 4-day (Day 0-3) follow-up period post-vaccination

13. 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 (Day 0-30) follow-up period post-vaccination

14. 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: During the entire study period (Day 0-Month 3)

Baseline characteristics

Publications

• Chatterjee S, Rego SJ, D'Souza F, Bhatia BD, Collard A, Datta SK, Jacquet JM. The immunogenicity and safety of a reduced PRP-content DTPw-HBV/Hib vaccine when administered according to the accelerated EPI schedule. BMC Infect Dis. 2010 Oct 15;10:298. doi: 10.1186/1471-2334-10-298. PubMed 20950457 ↗

Related links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.