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

Hepatitis B Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332566
• Other study ID #: 106602
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2006
• Last updated: September 27, 2016
• Start date: June 2006
• Est. completion date: October 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nicaragua: National Center for Health investigation
• Study type: Interventional

Clinical Trial Summary

This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 24 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b
• Hepatitis B
• Tetanus
• Whole Cell Pertussis

Intervention

Biological:
• DTPw-HBV/Hib Kft vaccine GSK323527A
Intramuscular injection, 1 dose
• Tritanrix™-HepB/Hiberix™
Intramuscular injection, 1 dose

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Nicaragua	GSK Investigational Site	Leon

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Argentina,  Nicaragua, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration		One month after the booster dose	No
Primary	Anti-hepatitis B surface antigen (HBs) antibody concentration		One month after the booster dose	No
Primary	Anti-diphtheria antibody concentration		One month after the booster dose	No
Primary	Anti-tetanus antibody concentration		One month after the booster dose	No
Secondary	Anti-Bordetella pertussis (BPT) antibody concentration		One month after the booster dose	No
Secondary	Anti-PRP antibody concentration		Prior to the booster dose	No
Secondary	Anti-HBs antibody concentration		Prior to the booster dose	No
Secondary	Anti-diphtheria antibody concentration		Prior to the booster dose	No
Secondary	Anti-tetanus antibody concentration		Prior to the booster dose	No
Secondary	Anti-BPT antibody concentration		Prior to the booster dose	No
Secondary	Occurrence of solicited symptoms		During the 4-day follow-up period after the booster dose	Yes
Secondary	Occurrence of unsolicited symptoms		During the 31-day follow-up period after the booster dose	Yes
Secondary	Occurrence of serious adverse events		During the entire study period.	Yes

External Links

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