Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2016
• Main ID: NCT00332566
• Date of registration: 31/05/2006
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib
• Scientific title: Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals' DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals' DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.
• Date of first enrolment: June 2006
• Target sample size: 148
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00332566
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Argentina, Nicaragua

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.

- A male or female toddler, 18 to 24 months of age at the time of booster vaccination,
who completed the three-dose primary vaccination course in the 101223 study.

- 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 vaccines within 30 days preceding the booster dose of study vaccine, 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 vaccine dose.

- Planned administration/ administration of a vaccine not foreseen by the study
protocol during the period starting from 30 days before and ending 30 days after
administration of the booster vaccine dose, with the exception of oral polio vaccine
(OPV).

- Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B and
Hib disease since the conclusion visit of the 101223 study.

- History of diphtheria, tetanus, pertussis, hepatitis B and Hib disease.

- Known exposure to diphtheria, tetanus, pertussis, hepatitis B and Hib disease since
the conclusion visit of the 101223 study.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination

- 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 neurologic disorders or seizures.

- Acute disease at the time of enrolment.

- Administration of immunoglobulins and/or any blood products during the study period.

- Other conditions which in the opinion of the investigator may potentially interfere
with interpretation of study outcomes.

- One of the following adverse events that constitute absolute contraindications to
further administration of DTP vaccine, having occurred after previous administration
of DTPw vaccine.

- Known hypersensitivity to any component of the vaccine, or having shown signs of
hypersensitivity after previous administration of diphtheria, tetanus, pertussis
or HB vaccines.

- Encephalopathy

- Axillary temperature of >= 40 °C/ rectal temperature >= 40.5 °C within 48 hours
of vaccination.

- Collapse or shock-like state within 48 hours of vaccination.

- Persistent, inconsolable crying lasting >= 3 hours occurring within 48 hours of
vaccination.

- Seizures with or without fever occurring within 3 days of vaccination.



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

Health Condition(s) or Problem(s) studied

Hepatitis B

Whole Cell Pertussis

Haemophilus Influenzae Type b

Tetanus

Diphtheria

Intervention(s)

Biological: DTPw-HBV/Hib Kft vaccine GSK323527A

Biological: Tritanrix™-HepB/Hiberix™

Primary Outcome(s)

Anti-diphtheria antibody concentration [Time Frame: One month after the booster dose]

Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration [Time Frame: One month after the booster dose]

Anti-tetanus antibody concentration [Time Frame: One month after the booster dose]

Anti-hepatitis B surface antigen (HBs) antibody concentration [Time Frame: One month after the booster dose]

Secondary Outcome(s)

Anti-diphtheria antibody concentration [Time Frame: Prior to the booster dose]

Anti-BPT antibody concentration [Time Frame: Prior to the booster dose]

Anti-Bordetella pertussis (BPT) antibody concentration [Time Frame: One month after the booster dose]

Anti-HBs antibody concentration [Time Frame: Prior to the booster dose]

Anti-tetanus antibody concentration [Time Frame: Prior to the booster dose]

Occurrence of unsolicited symptoms [Time Frame: During the 31-day follow-up period after the booster dose]

Occurrence of serious adverse events [Time Frame: During the entire study period.]

Occurrence of solicited symptoms [Time Frame: During the 4-day follow-up period after the booster dose]

Anti-PRP antibody concentration [Time Frame: Prior to the booster dose]

Secondary ID(s)

106602

Source(s) of Monetary Support

Please refer to primary and secondary sponsors