Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children

NCT01245049 | Completed Phase 3 Results

• 1 other identifier: 111763
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.

Conditions

Acellular Pertussis; Poliomyelitis; Tetanus; Diphtheria

Keywords

MMR; dTpa-IPV; Boostrix Polio; Repevax; Priorix

Outcome Measures

Primary Outcomes (3)

• Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens

  Booster response was defined as: For initially seronegative subjects \[i.e. pre-vaccination concentration below (\<) cut-off value of 0.1 international units per milliliter (IU/mL)\] antibody concentrations at least four times the assay cut-off \[post vaccination concentration greater than or equal to (≥) 0.4 IU/ml\]. For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.

  At Month 1, one month after the booster vaccination

• Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

  Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  At Month 1, one month after the booster vaccination

• Anti-Polio Virus Type 1, 2 and 3 Antibody Titers

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

  At Month 1, one month after the booster vaccination

Secondary Outcomes (20)

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

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

• Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN

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

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

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

• Number of Seropositive Subjects for Anti-measles Antibody

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

• Number of Seropositive Subjects for Anti-mumps Antibody

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

Study Arms (2)

BOOSTRIX POLIO GROUP

EXPERIMENTAL

Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.

Biological: Boostrix PolioTM; Biological: PriorixTM

REPEVAX GROUP

ACTIVE COMPARATOR

Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.

Biological: RepevaxTM; Biological: PriorixTM

Interventions

Boostrix PolioTM BIOLOGICAL

Single dose, intramuscular administration.

BOOSTRIX POLIO GROUP

RepevaxTM BIOLOGICAL

Single dose, intramuscular administration.

REPEVAX GROUP

PriorixTM BIOLOGICAL

Single dose, intramuscular or subcutaneous administration.

BOOSTRIX POLIO GROUP; REPEVAX GROUP

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female child of 3 or 4 years of age at the time of booster vaccination (up to, but excluding 5 years of age).
• Subjects who have received a complete three-dose primary vaccination with diphtheria-tetanus-acellular pertussis (DTPa) vaccine and inactivated poliovirus (IPV) vaccine in the first six months of life, in line with recommendations in the United Kingdom (UK).
• Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine within the second year of life, in line with recommendations in the UK.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject at the time of enrolment.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product other than the study vaccine(s) 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.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of inactivated influenza vaccine.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis since primary vaccination in the first year of life.
• Previous measles, mumps and/or rubella second dose vaccination.
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and/or rubella disease.
• Known exposure to measles, mumps and/or rubella within 30 days prior to study start.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation.
• Occurrence of any of the following adverse events after a previous administration of a DTP vaccine:
• Hypersensitivity reaction to any component of the vaccine;

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

St Austell, Cornwall, PL26 7RL, United Kingdom

Location

GSK Investigational Site

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

GSK Investigational Site

Axbridge, Somerset, BS26 2BJ, United Kingdom

Location

GSK Investigational Site

Taunton, Somerset, TA1 1XQ, United Kingdom

Location

GSK Investigational Site

Atherstone, Warwickshire, CV9 1EU, United Kingdom

Location

GSK Investigational Site

Bangor, BT19 1PP, United Kingdom

Location

GSK Investigational Site

Bolton, Nr Manchester, BL3 6TL, United Kingdom

Location

GSK Investigational Site

Bristol, BS2 8AE, United Kingdom

Location

GSK Investigational Site

Crumpsall, Manchester, M8 9JT, United Kingdom

Location

GSK Investigational Site

Exeter, EX2 5DW, United Kingdom

Location

GSK Investigational Site

Lancashire, BL1 6AP, United Kingdom

Location

GSK Investigational Site

Oxford, OX3 7LJ, United Kingdom

Location

GSK Investigational Site

Randalstown, BT41 3AE, United Kingdom

Location

Related Publications (1)

• Marlow R, Kuriyakose S, Mesaros N, Han HH, Tomlinson R, Faust SN, Snape MD, Pollard AJ, Finn A. A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK. Vaccine. 2018 Apr 19;36(17):2300-2306. doi: 10.1016/j.vaccine.2018.03.021. Epub 2018 Mar 22.

  PMID: 29576304 DERIVED

Related Links

• IPD for this study will be made available via the Clinical Study Data Request site.

MeSH Terms

Conditions

Poliomyelitis; Tetanus; Diphtheria

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Corynebacterium Infections; Actinomycetales Infections

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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 22, 2010
• Study Start: April 1, 2011
• Primary Completion: March 27, 2012
• Study Completion: April 2, 2012
• Last Updated: August 17, 2018
• Results First Posted: July 5, 2017

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

GB (13)