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Completed

NCT Number: NCT00473668

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

The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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Key information

Conditions

Whole Cell Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Pasteurellaceae Infections Respiratory Tract Diseases Respiratory Tract Infections Tetanus Virus Diseases Whooping Cough

Age range

6 week–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bangalore, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of 36 to 42 weeks inclusive.
  • Administration of one dose of hepatitis B vaccine at birth

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 with the exception of OPV.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose, (with the exception of OPV).
  • Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
  • Hepatitis B vaccine received after the first week of life.
  • Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B (except hepatitis B at birth).
  • History of diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  • Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Treatment and study plan

Zilbrix-Hib

Biological

Intramuscular injection, 1 dose

Tritanrix™-HepB/ Hiberix™

Biological

Intramuscular injection, 1 dose

Primary outcomes

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

    Time frame: At Month 3

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

Secondary outcomes

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

    Time frame: At Month 3

    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).

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

    Time frame: At Month 3

    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).

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

    Time frame: At Month 3

    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.

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

    Time frame: At Month 3

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

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

    Time frame: At Month 3

    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).

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

    Time frame: At Month 3

    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.

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

    Time frame: At Month 3

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

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

    Time frame: At Month 3

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

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

    Time frame: At Month 3

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

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

    Time frame: At Month 3

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

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

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

    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.

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

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

    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.

  13. Number of Subjects With Any Unsolicited Adverse Events (AEs)

    Time frame: During the 31-day (Day 0-30) follow-up period post-vaccination

    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.

  14. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: During the entire study period (Day 0-Month 3)

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Non-inferiority of One Formulation of GSK Biologicals' DTPw-HBV/Hib to 2 Formulations of GSK Biologicals' DTPw-HBV/Hib With Respect to the Immune Response to the PRP Antigen, When Administered to Healthy Infants at 6, 10, 14 Weeks of Age

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 15, 2007
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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