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NCT Number: NCT01358825

Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™

The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.

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Key information

Conditions

Tetanus Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines Enterovirus Infections 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 Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Picornaviridae Infections Poliomyelitis RNA Virus Infections Spinal Cord Diseases Virus Diseases

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Morvik, Norway

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects who had received 3 doses of Infanrix hexa™ or Infanrix-IPV/Hib™ in study NCT00307034.
  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol.
  • A male or female subject aged 5 years at the time of study entry.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

  • Child in care.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Use of any investigational or non-registered product within 30 days prior to blood sampling.
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib vaccination or disease since the study NCT00307034, with the exception of hepatitis B vaccination in the DTPa-IPV/Hib group.
  • Administration of immunoglobulins and/or any blood products within the 3 months prior to blood sampling.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.

Treatment and study plan

blood sampling

Procedure

A blood sample will be taken at 5 years of age, after vaccination in the primary study.

Primary outcomes

  1. Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).

    Time frame: At Day 0

    A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)

  2. Concentrations of Antibodies Against Anti-D and Anti-T

    Time frame: At Day 0

    Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).

  3. Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).

    Time frame: At Day 0

    Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.

  4. Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.

    Time frame: At Day 0

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

  5. Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).

    Time frame: At Day 0

    Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).

  6. Concentrations of Antibodies Against Anti-HBs.

    Time frame: At Day 0

    Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).

  7. Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).

    Time frame: At Day 0

    A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)

  8. Concentrations of Antibodies Against Anti-PRP.

    Time frame: At Day 0

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

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

    Time frame: During the entire study period (up to Day 46)

    Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  10. Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL

    Time frame: At Day 0

    Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Antibody Persistence in Children Previously Vaccinated With Three Doses of Infanrix Hexa™ or Infanrix-IPV/Hib™

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 24, 2011
Registry last updated
Jan 19, 2021

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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