Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age

Hepatitis B Clinical Trial

Official title:

A Phase II, Observer-blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Combined DssiTgdPa-HBV-IPV/Hib Vaccine Containing Diphtheria Toxoid From the Statens Serum Institute (SSI) of Denmark and Tetanus Toxoid From GSK Biologicals' Kft [GD], Compared to the Currently Licensed GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa TM) When Administered to Healthy Infants at 2, 3 and 4 Months of Age.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376779
• Other study ID #: 106786
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2006
• Last updated: November 2, 2016
• Start date: October 2006
• Est. completion date: May 2007

Study information

• Verified date: November 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine. The vaccine will be administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Weeks to 12 Weeks

Eligibility

Inclusion Criteria:

• A healthy male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination.

• Written informed consent obtained from the parents/guardians of the subject.

• Born after a normal gestation period of 36 to 42 weeks.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 from birth until first primary vaccination dose.

• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

• Administration/planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose, with the exception of the human rotavirus (HRV) vaccine.

• 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 (pharmaceutical product or device).

• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenza type b (Hib) vaccination or disease.

• Hepatitis B virus (HBV) vaccination at birth.

• History of seizures or progressive neurological disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Haemophilus Influenzae Type b
• Hepatitis B
• Poliomyelitis
• Tetanus

Intervention

Biological:
• Infanrix hexa Vaccine

Locations

Country	Name	City	State
Finland	GSK Investigational Site	Jarvenpaa
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Pori
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
Finland	GSK Investigational Site	Vantaa

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody concentration/response to all vaccine antigens after vaccination
Secondary	Solicited (D0-3); unsolicited events (D0-30); serious adverse events (SAEs) (full study)

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.