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OpenTrials
Completed

NCT Number: NCT00412854

Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.

This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.

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Key information

Conditions

Tetanus Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Corynebacterium Infections Diphtheria Gram-Positive Bacterial Infections Infections

Age range

90 day–120 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Mengshan, China

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,
  • written informed consent obtained from the parent or guardian of the subject

Exclusion criteria

  • Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
  • Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.

Treatment and study plan

Infanrix™/Hib

Biological

Infanrix

Biological

Hiberix

Biological

Primary outcomes

  1. Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)

    Time frame: At Month 3

    A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).

  2. Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)

    Time frame: At Month 3

    A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).

  3. Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies

    Time frame: At Month 3

    The vaccine response was defined as it follows:

    • for PT and FHA, an antibody concentration higher than or equal to (≥) 20 EL.U/mL at post-vaccination;
    • for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points.

Secondary outcomes

  1. Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL

    Time frame: At Month 3

    The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.

  2. Concentrations for Anti-D and Anti-T Antibodies

    Time frame: At Month 0 and Month 3

    Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).

  3. Concentrations for Anti-PRP Antibodies

    Time frame: At Month 0 and Month 3

    Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).

  4. Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies

    Time frame: At Month 3

    Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

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

    Time frame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

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

    Time frame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses

    Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  7. Number of Subjects With Unsolicited Adverse Events (AEs)

    Time frame: During the 31-day (Day 0-30) follow-up period after each 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.

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

    Time frame: From receipt of first dose of study vaccine (Day 0) to study end (Month 3)

    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

Phase IIIb, Multicentre Study to Assess Safety & Immunogenicity of GSK Biologicals' Combined DTPa/Hib (Infanrix/Hib) Vaccine vs Separate Administration of DTPa (Infanrix) & Hib (Hiberix) Vaccines in Healthy Infants 3,4,&5 Months of Age as Compared With the Separate Administration of DTPa and Hib Vaccines at Different Injection Sites.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Dec 19, 2006
Registry last updated
Jun 6, 2018

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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