Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

Hepatitis B Clinical Trial

Official title:

Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320463
• Other study ID #: 105910
• Status: Completed
• Phase: Phase 3
• First received: February 21, 2006
• Last updated: October 11, 2016
• Start date: April 2006
• Est. completion date: January 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

In this study, infants will be randomly allocated into three groups:

• one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)

• the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)

• the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.

Description:

A study to compare the immunogenicity & safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' DTPa-HBV-IPV/Hib vaccine given in healthy infants at 3,4 & 5 months age. The immunogenicity & safety of DTPa-HBV-IPV vaccine will also be evaluated in a 3rd group of subjects Subjects in the group that will receive DTPa-HBV-IPV/Hib vaccine (current formulation) will be the control group for the group that will receive DTPa-HBV-IPV/Hib vaccine (new formulation)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Weeks to 17 Weeks

Eligibility

"Inclusion criteria:

• A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.

• Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available).

• Born after a normal gestation period (between 36 and 42 weeks).

• Written informed consent obtained from the parent or guardian of the subject.

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 of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

• Any chronic drug therapy to be continued during the study period.

• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.

• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.

• Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.

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
• Hepatitis B
• Poliomyelitis
• Tetanus

Intervention

Biological:
• DTPa-HBV-IPV/Hib vaccine

Locations

Country	Name	City	State
Russian Federation	GSK Investigational Site	Murmansk
Russian Federation	GSK Investigational Site	Perm
Russian Federation	GSK Investigational Site	Syktyvkar
Russian Federation	GSK Investigational Site	Syktyvkar

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One month after vaccination, measurement of antibodies against all vaccine antigens.
Secondary	Immunogenicity: One month after vaccination, vaccine response for the pertussis antigens.
Secondary	Reactogenicity & safety: After each dose, solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)."

External Links

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