Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly

Hepatitis B Clinical Trial

Official title:

Study to Assess Immunogenicity and Reactogenicity of SB Biologicals' DTPa-HBV-IPV/Hib Vaccine Given as Three-dose Primary Vaccination Course Compared to DTPa-IPV/Hib and HBV Administered Concomitantly at Separate Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457495
• Other study ID #: 217744/031
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2011
• Last updated: June 15, 2017
• Start date: September 1998
• Est. completion date: September 1999

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: September 1999
• Est. primary completion date: September 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Weeks to 16 Weeks

Eligibility

Inclusion Criteria:

• A male or female between 12 and 16 weeks of age at the time of the first vaccination.

• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

• Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

Exclusion Criteria:

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.

• Administration of chronic immunosuppressants or immune-modifying drugs during the study period.

• Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.

• Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.

• History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

• History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.

• Major congenital defects or serious chronic illness.

• Progressive neurological disorders.

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

• Acute febrile illness at the time of planned vaccination.

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b (Hib)
• Hepatitis B
• Pertussis
• Poliomyelitis
• Tetanus

Intervention

Biological:
• DTPa-HBV-IPV/Hib (Infanrix-hexa™)
3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
• DTPa-IPV/Hib (Infanrix-IPV/Hib™)
3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
• HBV (Engerix™-B)
3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with antibody titers equal to or greater than cut-off value.		One month after the 2nd dose of the primary vaccination course (month 3)
Secondary	Immunogenicity with respect to components of the study vaccines in terms of number of seropositive subjects		One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9)
Secondary	Immunogenicity with respect to components of the study vaccines in terms of antibody titers		One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9)
Secondary	Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response		One month after the 3rd dose of the primary vaccination course (Month 9)
Secondary	Occurrence of solicited local symptoms		Within 4 days after each vaccination and overall
Secondary	Occurrence of solicited general symptoms		Within 4 days after each vaccination and overall
Secondary	Occurrence of unsolicited symptoms		Within 30 days after each vaccination, and overall
Secondary	Occurrence of serious AEs		Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination