Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine

NCT00880477 | Completed Phase 3

• 1 other identifier: 217744/069
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course and as a booster dose in infants born to hepatitis B antigen seronegative mothers and previously primed with a birth dose of GSK's HBV vaccine.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Seroprotective anti-HBs antibody titres above protocol specified cut-off value

  At the time of the second dose of combined vaccination, one month after the 3rd dose of combined vaccination and one month after the booster dose.

Secondary Outcomes (4)

• Antibody titres against all investigational vaccine antigen components

  One month after first combined vaccine dose, two months after Dose 1, one month after third combined vaccine dose prior to booster vaccination and one month post-booster vaccination.

• Occurrence of solicited symptoms

  During the 4-day follow-up period after each dose

• Occurrence of unsolicited symptoms

  During the 30-day follow-up period after each dose of study vaccine

• Occurrence of Serious Adverse Events

  From the birth dose of hepatitis B vaccine and ending with the last study visit or performance of the last study procedure or a minimum of 30 days following the third dose of the mixed vaccines and from the start of booster dose and ending a minimum of 3

Study Arms (2)

Group A

EXPERIMENTAL

Biological: DTPa-HBV-IPV/Hib vaccine

Group B

EXPERIMENTAL

Biological: DTPa-IPV/Hib vaccine; Biological: EngerixTM-B

Interventions

DTPa-HBV-IPV/Hib vaccine BIOLOGICAL

Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.

Group A

DTPa-IPV/Hib vaccine BIOLOGICAL

Vaccination according to a 3-dose schedule at at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.

Group B

EngerixTM-B BIOLOGICAL

The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age.

Group B

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent obtained from the parents or guardians of the subject.
• A male or female infant born after a normal gestation period (between 36 and 42 weeks).
• Born to a mother seronegative for HBsAg.
• Free of obvious health problems as established by clinical examination before entering into the study.
• Between, and including, 6 and 8 weeks of age at the time of the first dose of the three-dose course of vaccination.
• Free of obvious health problems as established by medical history and clinical examination before entering into this phase of the study.
• Between, and including, 15 and 18 months of age at the time of the booster vaccination.
• Written informed consent obtained from the parents or guardians of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Completion of the three-dose primary vaccination course.

You may not qualify if:

• A family history of congenital or hereditary immunodeficiency.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• Major congenital defect(s).
• 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.
• Chronic administration Immunosuppressants or other immune-modifying drugs since birth.
• Any chronic drug therapy to be continued during the study period.
• Planned administration/ administration of a vaccine except Bacille Calmette-Guérin vaccine during the period starting from 30 days before each dose of vaccines and ending 30 days after.
• Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease.
• History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Haemophilus influenzae type b disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• Shao PL, Lu CY, Hsieh YC, Bock HL, Huang LM; Taiwan Infanrix-069 Study Group. Immunogenicity and reactogenicity of DTPa-IPV/Hib vaccine co-administered with hepatitis B vaccine for primary and booster vaccination of Taiwanese infants. J Formos Med Assoc. 2011 Jun;110(6):415-22. doi: 10.1016/S0929-6646(11)60061-2.

  PMID: 21741011 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

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: April 9, 2009
• First Posted: April 13, 2009
• Study Start: January 1, 2001
• Primary Completion: November 1, 2002
• Study Completion: November 1, 2002
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share