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

Primary Purpose

Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

DTPa-HBV-IPV/Hib (Infanrix hexa™)

OPV

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Oral polio vaccine (OPV), DTPa-HBV-IPV/Hib vaccine

Eligibility Criteria

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

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 If any of these criteria becomes applicable during the study, the subject should be withdrawn.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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group A

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values

Number of subjects with solicited and unsolicited adverse events

Number of subjects with serious adverse events

Full Information

NCT ID

NCT01457560

First Posted

October 20, 2011

Last Updated

August 4, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01457560

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

February 2000 (undefined)

Primary Completion Date

April 2001 (Actual)

Study Completion Date

April 2001 (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 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.

6. Conditions and Keywords

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

Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria, Tetanus, Poliomyelitis

Keywords

Oral polio vaccine (OPV), DTPa-HBV-IPV/Hib vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

DTPa-HBV-IPV/Hib (Infanrix hexa™)

Intervention Description

Three doses administered intramuscularly

Intervention Type

Biological

Intervention Name(s)

OPV

Intervention Description

One dose administered orally

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

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 )

Title

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).

Title

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).

Title

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).

Title

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

Title

Number of subjects with serious adverse events

Time Frame

During the study period (Month 0 to Month 9)

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: 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.

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

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

22349525

Citation

Van Der Meeren O, Kuriyakose S, Kolhe D, Hardt K. Immunogenicity of Infanrix hexa administered at 3, 5 and 11 months of age. Vaccine. 2012 Apr 5;30(17):2710-4. doi: 10.1016/j.vaccine.2012.02.024. Epub 2012 Feb 18.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

217744/060

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

217744/060

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

217744/060

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

217744/060

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

217744/060

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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