Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.

NCT00871000 | Completed Phase 3 Results

• 1 other identifier: 111815
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 8

Brief Summary

This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine according to the "3-5-11" month schedule recommended in Italy. In this study, MMRV vaccine will also be co-administered to all children.

Conditions

Acellular Pertussis; Tetanus; Diphtheria; Poliomyelitis

Keywords

Boostrix Polio; dTpa-IPV

Outcome Measures

Primary Outcomes (4)

• Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations

  Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.

  At Month 1, one month post-vaccination

• Anti-poliovirus Types 1, 2 and 3 Antibody Titres

  Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8.

  At Month 1, one month post-vaccination

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

  A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay.

  At Month 1, one month post-vaccination

• Number of Seropositive Subjects for Anti-D and Anti-T Antibodies

  A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA).

  At Month 1, one month post-vaccination

Secondary Outcomes (15)

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

  At Month 1, one month post-vaccination

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

  At Month 1, one month post-vaccination

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

  At Month 1, one month post-vaccination

• Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella

  At Month 1, one month post-vaccination

• Anti-measles and Anti-varicella Antibody Concentrations

  At Month 1, one month post-vaccination

Study Arms (2)

BOOSTRIX POLIO GROUP

EXPERIMENTAL

Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.

Biological: Boostrix Polio™ 711866; Biological: Priorix Tetra TM 208136

TETRAVAC GROUP

ACTIVE COMPARATOR

Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.

Biological: Priorix Tetra TM 208136; Biological: Tetravac TM

Interventions

Boostrix Polio™ 711866 BIOLOGICAL

Single dose, intramuscular administration.

Also known as: dTpa-IPV

BOOSTRIX POLIO GROUP

Priorix Tetra TM 208136 BIOLOGICAL

Single dose, subcutaneously.

Also known as: MMRV

BOOSTRIX POLIO GROUP; TETRAVAC GROUP

Tetravac TM BIOLOGICAL

Single dose, intramuscular administration.

Also known as: DTPa-IPV

TETRAVAC GROUP

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A male or female child of 5 and 6 years of age at the time of vaccination.
• Subjects who received a complete 3-dose vaccination with a DTPa-based combined vaccine according to a 3-5-11 month schedule in line with recommendations in Italy.
• Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine in the second year of life, in line with recommendations in Italy.
• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• 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 other than the study vaccine(s) within 30 days preceding the first 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.
• 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 tetanus, diphtheria, pertussis and/or poliomyelitis since vaccination in the first two years of life.
• Previous measles, mumps, rubella and/or varicella second dose vaccination.
• Known history of diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps, rubella and/or varicella disease.
• Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Administration of immunoglobulin and/or any blood products within the three months preceding vaccination or planned administration during the study period.
• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
• Occurrence of any of the following adverse events after a previous administration of a DTP vaccine:
• Hypersensitivity reaction to any component of the vaccine;
• Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine;

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Genoa, Liguria, 16132, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20122, Italy

Location

GSK Investigational Site

Novara, Piedmont, 28100, Italy

Location

GSK Investigational Site

Cagliari, Sardinia, 09127, Italy

Location

GSK Investigational Site

Catania, Sicily, 95129, Italy

Location

GSK Investigational Site

Modica (RG), Sicily, 97100, Italy

Location

GSK Investigational Site

Ragusa, Sicily, 97100, Italy

Location

GSK Investigational Site

Vittoria (RG), Italy

Location

Related Publications (3)

• Ferrera G, Cuccia M, Mereu G, Icardi G, Bona G, Esposito S, Marchetti F, Messier M, Kuriyakose S, Hardt K. Booster vaccination of pre-school children with reduced-antigen-content diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine co-administered with measles-mumps-rubella-varicella vaccine: a randomized, controlled trial in children primed according to a 2 + 1 schedule in infancy. Hum Vaccin Immunother. 2012 Mar;8(3):355-62. doi: 10.4161/hv.18650. Epub 2012 Feb 13.

  PMID: 22327497 BACKGROUND

• Ferrera G et al. A comparison of the immunogenicity and safety of a booster dose of reduced-antigen-content with full-strength DTPa-IPV vaccines administered with MMRV to children 5-6 years of age. Abstract presented at the 44th Congresso Nazionale Societa Italiana di Igiene, Medicina Preventiva e Sanita Pubblica (SITI). Venezia, Italia, 3-6 October, 2010.

  BACKGROUND

• Ferrera G et al. Immunogenicity and safety of Booster vaccination with reduced-antigen-content or full-strength Diphtheria-Tetanus-Acellular-Pertussis-IPV vaccines in pre-school children, primed with a 2+1 schedule. Abstract presented at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). The Hague, The Netherlands, 7-11 June 2011.

  BACKGROUND

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

Tetanus; Diphtheria; Poliomyelitis

Interventions

DTPa-HBV-IPV combined vaccine

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales 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

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: March 26, 2009
• First Posted: March 30, 2009
• Study Start: April 1, 2009
• Primary Completion: November 18, 2009
• Study Completion: November 18, 2009
• Last Updated: June 6, 2018
• Results First Posted: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (8)