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

NCT00366366 | Completed Phase 3

• 1 other identifier: 217744/075
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Anti-HBs conc >=10 mIU/ml, 1 month after the last vaccine dose

Secondary Outcomes (2)

• Ab conc/titers against all vaccine antigens

• Safety: Solicited symptoms, unsolicited AEs and SAEs

Interventions

Infanrix-Hexa BIOLOGICAL

Eligibility Criteria

• Age: 11 Weeks - 17 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related 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 Singap. 2007 Oct;36(10):801-6.

  PMID: 17987229 BACKGROUND

Related 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.

MeSH Terms

Conditions

Hepatitis B

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2006
• First Posted: August 21, 2006
• Study Start: September 1, 2001
• Primary Completion: September 1, 2002
• Study Completion: September 1, 2002
• Last Updated: September 16, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share