Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine

NCT00627458 | Completed Phase 2 Results

• 1 other identifier: 111344
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).

Conditions

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

Keywords

Hexavalent vaccine; Booster

Outcome Measures

Primary Outcomes (21)

• Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids

  A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

  Before the booster administration (At Month 0)

• Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids

  A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.

  One month after the booster vaccination (At Month 1)

• Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)

  A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.

  Before the booster vaccination (At Month 0)

• Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)

  A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.

  One month after the booster vaccination (At Month 1)

• Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3

  A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.

  Before the booster vaccination (At Month 0)

• Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3

  A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.

  One month after the booster vaccination (At Month 1)

• Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)

  A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  Before the booster vaccination (At Month 0)

• Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)

  A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.

  One month after the booster vaccination (At Month 1)

• Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)

  A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.

  Before the booster vaccination (At Month 0)

• Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)

  A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.

  One month after the booster vaccination (At Month 1)

• Number of Subjects With a Vaccine Response to PT, FHA and PR

  Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) \[i.e. with concentrations lower than (\<) the cut-off value\] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) \[i.e. with concentrations greater than (\>) the cut-off value).

  One month after the booster vaccination (At Month 1)

• Anti-D and Anti-T Antibody Concentrations

  Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

  Before the booster vaccination (At Month 0)

• Anti-D and Anti-T Antibody Concentrations

  Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

  One month after the booster vaccination (At Month 1)

• Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

  Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

  Before the booster vaccination (At Month 0)

• Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

  Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

  One month after the booster vaccination (At Month 1)

• Anti-HBs Antibody Concentrations

  Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

  Before the booster vaccination (At Month 0)

• Anti-HBs Antibody Concentrations

  Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

  One month after the booster vaccination (At Month 1)

• Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers

  Antibody titers were presented as geometric mean titers (GMTs).

  Before the booster vaccination (At Month 0)

• Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers

  Antibody titers were presented as geometric mean titers (GMTs).

  One month after the booster vaccination (At Month 1)

• Anti-PRP Antibody Concentrations

  Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).

  Before the booster vaccination (At Month 0)

• Anti-PRP Antibody Concentrations

  Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.

  One month after the booster vaccination (At Month 1)

Secondary Outcomes (16)

• Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids

  Before (Month 0) and one month after (Month 1) the booster vaccination

• Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)

  Before (Month 0) and one month after (Month 1) the booster vaccination

• Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3

  Before (Month 0) and one month after (Month 1) the booster vaccination

• Number of Seroprotected Subjects Against PT, FHA and PRN

  Before (Month 0) and one month after (Month 1) the booster vaccination

• Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)

  Before (Month 0) and one month after (Month 1) the booster vaccination

Study Arms (3)

INFANRIX HEXA PF GROUP

EXPERIMENTAL

Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.

Biological: Infanrix Hexa

INFANRIX HEXA PC GROUP

EXPERIMENTAL

Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.

Biological: Infanrix Hexa

CONTROL GROUP

ACTIVE COMPARATOR

Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.

Biological: Infanrix Hexa

Interventions

Infanrix Hexa BIOLOGICAL

Vaccine administered as a booster dose at 16-20 months of age

Also known as: GSK Biological's combined DTPa-HBV-IPV/Hib vaccine

CONTROL GROUP; INFANRIX HEXA PC GROUP; INFANRIX HEXA PF GROUP

Eligibility Criteria

• Age: 16 Months - 20 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
• Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
• A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
• Written informed consent obtained from the parent or guardian of the subject
• Healthy subjects as established by medical history and clinical examination before entering into the study.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
• Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
• Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Oulu, 90220, Finland

Location

GSK Investigational Site

Pori, 28100, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Vantaa, 01300, Finland

Location

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

Diphtheria; Poliomyelitis; Haemophilus Infections; Tetanus; Hepatitis B

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Clostridium Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: March 3, 2008
• Study Start: February 1, 2008
• Primary Completion: August 18, 2008
• Study Completion: August 18, 2008
• Last Updated: June 6, 2018
• Results First Posted: June 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

FI (6)