Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00696423
• Date of registration: 05/06/2008
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children
• Scientific title: Immunogenicity and Reactogenicity Study of GlaxoSmithKline Biologicals' Infanrix™/Hib Vaccine Administered as a Booster Dose to 18-24 Months Old Children
• Date of first enrolment: June 7, 2008
• Target sample size: 467
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00696423
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.



Age minimum: 18 Months
Age maximum: 24 Months
Gender: All

Health Condition(s) or Problem(s) studied

Tetanus

Diphtheria

Acellular Pertussis

Intervention(s)

Biological: Hiberix™

Biological: Infanrix™

Primary Outcome(s)

Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations [Time Frame: One month after booster vaccination]

Anti-tetanus Toxoid Antibody Concentrations [Time Frame: One month after booster vaccination]

Anti-diphtheria Toxoid Antibody Concentrations [Time Frame: One month after booster vaccination]

Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations [Time Frame: One month after booster vaccination]

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 [Time Frame: One month after booster vaccination]

Secondary Outcome(s)

Number of Subjects Reporting Unsolicited Adverse Events (AE) [Time Frame: During the 31-day follow-up period after booster vaccination]

Number of Subjects Reporting Solicited Local and General Symptoms [Time Frame: During the 4-day follow-up period after booster vaccination]

Number of Subjects Reporting Serious Adverse Events (SAE) [Time Frame: During the 31-day follow-up period after booster vaccination]

Anti-PRP Antibody Concentrations [Time Frame: Before booster vaccination]

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 [Time Frame: Before booster vaccination]

Anti-diphtheria Toxoid Antibody Concentrations [Time Frame: Before booster vaccination]

Anti-tetanus Toxoid Antibody Concentrations [Time Frame: Before booster vaccination]

Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [Time Frame: Before booster vaccination]

Secondary ID(s)

111535

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/08/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00696423