Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine

August 4, 2016 updated by: GlaxoSmithKline

Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Mixed With Hib Vaccine in Healthy Infants, Followed by a Dose of the Same Vaccine Administered Simultaneously With One Dose of Oral Polio Vaccine (OPV)

This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 3 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study.

  • Healthy male and female subjects in the ≥12 and <16 weeks of life 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/guardians of the infant 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:

The exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn.

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination).
  • Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
  • Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
  • History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of seizures or of any neurological disease at study entry.
  • Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
  • Acute disease at the time of enrolment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™)
Three doses administered intramuscularly
Biological: OPV
One dose administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
Time Frame: One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)
One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
Time Frame: Before the first dose ( Month 0 )
Before the first dose ( Month 0 )
Immunogenicity with respect to the components of the study vaccine in terms of antibody titers
Time Frame: Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).
Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response
Time Frame: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values
Time Frame: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Number of subjects with solicited and unsolicited adverse events
Time Frame: After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall
After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall
Number of subjects with serious adverse events
Time Frame: During the study period (Month 0 to Month 9)
During the study period (Month 0 to Month 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Primary Completion (Actual)

April 1, 2001

Study Completion (Actual)

April 1, 2001

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

October 20, 2011

First Posted (Estimate)

October 24, 2011

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217744/060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Informed Consent Form
    Information identifier: 217744/060
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: 217744/060
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: 217744/060
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: 217744/060
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: 217744/060
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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