To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines

Hepatitis B Clinical Trial

Official title:

Phase III, Open, Randomised Immunogenicity and Reactogenicity Study to Assess the Interchangeability Between GSK Bios' DTPa-HBV-IPV/Hib and DTPa-IPV/Hib + HBV at 3rd Dose of Primary Vac. Course in Children Who Received HBV Vac. at Birth and One Month of Age and DTPa-IPV/Hib Vac at 3-4 Mth of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366366
• Other study ID #: 217744/075
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2006
• Last updated: September 15, 2016
• Start date: September 2001
• Est. completion date: September 2002

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2 doses of the primary vaccination course. At 5 months of age, they received either the DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV vaccine at birth and at 1 month of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2002
• Est. primary completion date: September 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Weeks to 17 Weeks

Eligibility

Inclusion Criteria:

• A male or female infant at the age of 11 - 17 weeks.

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

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

• Hepatitis B vaccine at birth and one month of age.

Exclusion Criteria:

• Previous vaccination against measles, mumps, rubella and/or varicella.

• Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• A family history of congenital or hereditary immunodeficiency.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.

• Major congenital defects.

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Biological:
• Infanrix-Hexa

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (1)

Lim FS, Han HH, Jacquet JM, Bock HL. Primary vaccination of infants against hepatitis B can be completed using a combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis-Haemophilus influenzae type B vaccine. Ann Acad Med Singapore. 2007 Oct;36(10):801-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs conc >=10 mIU/ml, 1 month after the last vaccine dose
Secondary	Ab conc/titers against all vaccine antigens
Secondary	Safety: Solicited symptoms, unsolicited AEs and SAEs

External Links

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