Back to results

Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

Primary Purpose

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

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

DTPa-HBV-IPV/Hib (Infanrix hexa™)

DTPa-HBV-IPV (Infanrix penta™)

Hib (Hiberix™)

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring combination vaccine, DTPa-HBV-IPV, Hib

Eligibility Criteria

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

Inclusion Criteria:

A male or female 3 months 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:

The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:

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, including allergic reactions to neomycin and polymyxin B.
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 time of enrolment

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Subjects will receive one single injection of DTPa-HBV-IPV vaccine mixed with Hib vaccine.

Subjects will receive two separate injections of DTPa-HBV-IPV and Hib vaccine.

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 value

Secondary Outcome Measures

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

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

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

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

Occurrence of solicited local symptoms

Occurrence of solicited general symptoms

Occurrence of unsolicited symptoms

Occurrence of serious adverse events

Full Information

NCT ID

NCT01457508

First Posted

October 20, 2011

Last Updated

June 15, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01457508

Brief Title

Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

Official Title

Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vaccine Administered Separately

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

January 1999 (undefined)

Primary Completion Date

March 2000 (Actual)

Study Completion Date

March 2000 (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 GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) 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

combination vaccine, DTPa-HBV-IPV, Hib

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

440 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Subjects will receive one single injection of DTPa-HBV-IPV vaccine mixed with Hib vaccine.

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

Subjects will receive two separate injections of DTPa-HBV-IPV and Hib vaccine.

Intervention Type

Biological

Intervention Name(s)

DTPa-HBV-IPV/Hib (Infanrix hexa™)

Intervention Description

Three doses administered intramuscularly

Intervention Type

Biological

Intervention Name(s)

DTPa-HBV-IPV (Infanrix penta™)

Intervention Description

Three doses administered intramuscularly

Intervention Type

Biological

Intervention Name(s)

Hib (Hiberix™)

Intervention Description

Three doses administered intramuscularly

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 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 the components of the study vaccines in terms of number of seroprotected subjects

Time Frame

One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)

Title

Immunogenicity with respect to the 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 ( Month 8 and 9)

Title

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

Time Frame

One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)

Title

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

Time Frame

One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3)

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 adverse events

Time Frame

Throughout the entire study up to and including 30 days post-vaccination ( 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: A male or female 3 months 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: The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study: 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, including allergic reactions to neomycin and polymyxin B. 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 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

Citations:

Citation

Crovari P. et al. Immunogenicity and reactogenicity of combined DTPa-HBV-IPV/Hib vaccine compared to concomitant administered DTPa-HBV-IPV and Hib vaccines given at 3, 5 and 11 months of age. Abstract presented at the 19th Annual Meeting ESPID, Istanbul, Turkey, 26-28 March 2001.

Results Reference

background

PubMed Identifier

15370670

Citation

Gabutti G, Zepp F, Schuerman L, Dentico P, Bamfi F, Soncini R, Habermehl P, Knuf M, Crovari P; Cooperative Italian Group for the Study of Combined Vaccines. Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV Combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age. Scand J Infect Dis. 2004;36(8):585-92. doi: 10.1080/00365540410017572.

Results Reference

background

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

derived

Learn more about this trial

Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

We'll reach out to this number within 24 hrs