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Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00696423
  Purpose

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Haemophilus Influenzae Type b Disease
Biological: Hiberix
Biological: Infanrix
Phase III

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: Immunogenicity and Reactogenicity Study of GlaxoSmithKline Biologicals' Infanrix™/Hib Vaccine Administered as a Booster Dose to 18-24 Months Old Children

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentrations [ Time Frame: One month after booster vaccination ] [ Designated as safety issue: No ]
  • Anti-diphtheria toxoid antibody concentrations [ Time Frame: One month after booster vaccination ] [ Designated as safety issue: No ]
  • Anti-tetanus toxoid antibody concentrations [ Time Frame: One month after booster vaccination ] [ Designated as safety issue: No ]
  • Anti-pertussis toxoid (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN) antibody concentrations [ Time Frame: One month after booster vaccination ] [ Designated as safety issue: No ]
  • Anti-PRP, anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-PRN antibody concentrations [ Time Frame: One month after booster vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-PT, anti-FHA and anti-PRN antibody concentrations [ Time Frame: Before booster vaccination ] [ Designated as safety issue: No ]
  • Anti-PRP, anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations [ Time Frame: Before booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after booster vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after booster vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events (SAEs) [ Time Frame: Following booster vaccination ] [ Designated as safety issue: Yes ]
  • Anti-PRP antibody concentrations [ Time Frame: Before booster vaccination ] [ Designated as safety issue: No ]
  • Anti-diphtheria toxoid antibody concentrations [ Time Frame: Before booster vaccination ] [ Designated as safety issue: No ]
  • Anti-tetanus toxoid antibody concentrations [ Time Frame: Before booster vaccination ] [ Designated as safety issue: No ]

Enrollment: 466
Study Start Date: June 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A: Experimental
Group A: subjects in this group will receive the Infanrix/Hib vaccine
Biological: Hiberix
Intramuscular injection, one dose
Biological: Infanrix
Intramuscular injection, one dose
Group B: Active Comparator
Group B: subjects in this group will receive two separate injections of Infanrix and Hiberix vaccines
Biological: Hiberix
Intramuscular injection, one dose
Biological: Infanrix
Intramuscular injection, one dose

  Eligibility

Ages Eligible for Study:   18 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • Subjects should have completed the full three-dose primary vaccination course in study 104567.
  • A male or female child between, and including, 18 and 24 months of age at the time of the booster 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.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding booster vaccination, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of measles or combined measles, mumps and rubella (MMR) vaccination.
  • 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.
  • Previous booster vaccination against diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases since the end of the primary study.
  • History of diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • 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 progressive neurological disorders or seizures.
  • Acute disease and/or fever at time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Occurrence of any of the following adverse events (AEs) after previous administration of a DTP vaccine:

    • Hypersensitivity reaction due to any component of the vaccine.
    • Encephalopathy.
    • Fever >= 40.0 °C (axillary temperature) within 48 hours of vaccination.
    • Collapse or shock-like state within 48 hours of vaccination.
    • Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting >= 3 hours.
    • Seizures with or without fever occurring within 3 days of vaccination.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696423

Locations
China, Guangxi
GSK Investigational Site
Nanning, Guangxi, China, 530021
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: 111535
Study First Received: June 5, 2008
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00696423  
Health Authority: China: State Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Chinese children
Infanrix/Hib

Study placed in the following topic categories:
Bacterial Infections
Haemophilus influenzae
Whooping Cough
Cough
Diphtheria
Orthomyxoviridae Infections
Tetanus
Whooping cough
Gram-Negative Bacterial Infections
Virus Diseases
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Influenza, Human

Additional relevant MeSH terms:
Bordetella Infections
RNA Virus Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 15, 2009