Clinical trial NCT00696423: Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children
Official title: Immunogenicity and Reactogenicity Study of GlaxoSmithKline Biologicals' Infanrix™/Hib Vaccine Administered as a Booster Dose to 18-24 Months Old Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acellular Pertussis
Diphtheria
Tetanus
Keywords: Infanrix/Hib
Chinese children
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-12
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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 diphtheria-tetanus-pertussis (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.

Primary outcomes:
measure: Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations
timeFrame: One month after booster vaccination
measure: Anti-diphtheria Toxoid Antibody Concentrations
timeFrame: One month after booster vaccination
measure: Anti-tetanus Toxoid Antibody Concentrations
timeFrame: One month after booster vaccination
measure: Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
timeFrame: One month after booster vaccination
measure: The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
timeFrame: One month after booster vaccination
Secondary outcomes:
measure: Anti-PRP Antibody Concentrations
timeFrame: Before booster vaccination
measure: Anti-diphtheria Toxoid Antibody Concentrations
timeFrame: Before booster vaccination
measure: Anti-tetanus Toxoid Antibody Concentrations
timeFrame: Before booster vaccination
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: Before booster vaccination
measure: The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
timeFrame: Before booster vaccination
measure: Number of Subjects Reporting Solicited Local and General Symptoms
timeFrame: During the 4-day follow-up period after booster vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events (AE)
timeFrame: During the 31-day follow-up period after booster vaccination
measure: Number of Subjects Reporting Serious Adverse Events (SAE)
timeFrame: During the 31-day follow-up period after booster vaccination
Other outcomes:
Locations:
city: Liucheng County
country: China
facility: GSK Investigational Site
state: Guangxi
city: Mengshan
country: China
facility: GSK Investigational Site
city: Wuzhou
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: