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

Primary Purpose

Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib)

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

DTPa-HBV-IPV/Hib (Infanrix-hexa™)

DTPa-IPV/Hib (Infanrix-IPV/Hib™)

HBV (Engerix™-B)

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Infants, combined vaccine, DTPa-HBV-IPV/Hib, DTPa-IPV/Hib, safety, Immunogenicity, HBV

Eligibility Criteria

12 Weeks - 16 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DTPa 1 Group

DTPa 2 Group

Arm Description

Outcomes

Primary Outcome Measures

Number of subjects with antibody titers equal to or greater than cut-off value.

Secondary Outcome Measures

Immunogenicity with respect to components of the study vaccines in terms of number of seropositive subjects

Immunogenicity with respect to components of the study vaccines in terms of antibody titers

Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response

Occurrence of solicited local symptoms

Occurrence of solicited general symptoms

Occurrence of unsolicited symptoms

Occurrence of serious AEs

Full Information

NCT ID

NCT01457495

First Posted

October 13, 2011

Last Updated

June 15, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01457495

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

September 1998 (undefined)

Primary Completion Date

September 1999 (Actual)

Study Completion Date

September 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Infants, combined vaccine, DTPa-HBV-IPV/Hib, DTPa-IPV/Hib, safety, Immunogenicity, HBV

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

312 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DTPa 1 Group

Arm Type

Experimental

Arm Title

DTPa 2 Group

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

DTPa-HBV-IPV/Hib (Infanrix-hexa™)

Intervention Description

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

Intervention Type

Biological

Intervention Name(s)

DTPa-IPV/Hib (Infanrix-IPV/Hib™)

Intervention Description

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

Intervention Type

Biological

Intervention Name(s)

HBV (Engerix™-B)

Intervention Description

3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8

Primary Outcome Measure Information:

Title

Number of subjects with antibody titers equal to or greater than cut-off value.

Time Frame

One month after the 2nd dose of the primary vaccination course (month 3)

Secondary Outcome Measure Information:

Title

Immunogenicity with respect to components of the study vaccines in terms of number of seropositive subjects

Time Frame

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)

Title

Immunogenicity with respect to components of the study vaccines in terms of antibody titers

Time Frame

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)

Title

Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response

Time Frame

One month after the 3rd dose of the primary vaccination course (Month 9)

Title

Occurrence of solicited local symptoms

Time Frame

Within 4 days after each vaccination and overall

Title

Occurrence of solicited general symptoms

Time Frame

Within 4 days after each vaccination and overall

Title

Occurrence of unsolicited symptoms

Time Frame

Within 30 days after each vaccination, and overall

Title

Occurrence of serious AEs

Time Frame

Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Weeks

Maximum Age & Unit of Time

16 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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