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

NCT ID: NCT00871000

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-01
• Study Completion Date: 2009-11-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BOOSTRIX POLIO GROUP

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.

Group Type: EXPERIMENTAL

Boostrix Polio™ 711866

Intervention Type: BIOLOGICAL

Single dose, intramuscular administration.

Priorix Tetra TM 208136

Intervention Type: BIOLOGICAL

Single dose, subcutaneously.

TETRAVAC GROUP

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.

Group Type: ACTIVE_COMPARATOR

Priorix Tetra TM 208136

Intervention Type: BIOLOGICAL

Single dose, subcutaneously.

Tetravac TM

Intervention Type: BIOLOGICAL

Single dose, intramuscular administration.

Interventions

Boostrix Polio™ 711866

Single dose, intramuscular administration.

Intervention Type: BIOLOGICAL

Priorix Tetra TM 208136

Single dose, subcutaneously.

Intervention Type: BIOLOGICAL

Tetravac TM

Single dose, intramuscular administration.

Intervention Type: BIOLOGICAL

Other Intervention Names

dTpa-IPV; MMRV; DTPa-IPV

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• Fever >= 40°C within 48 hours of vaccination, not due to another identifiable cause;
• Collapse or shock-like state within 48 hours of vaccination;
• Convulsions with or without fever, occurring within 3 days of vaccination.
• Residence in the same household as a person high risk for varicella

• Current febrile illness or axillary temperature ≥ 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Novara, Piedmont, Italy

GSK Investigational Site

Cagliari, Sardinia, Italy

GSK Investigational Site

Catania, Sicily, Italy

GSK Investigational Site

Modica (RG), Sicily, Italy

GSK Investigational Site

Ragusa, Sicily, Italy

GSK Investigational Site

Vittoria (RG), , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 22327497 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

Study Documents

Document Type: Statistical Analysis Plan

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

View Document

Document Type: Dataset Specification

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

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Document Type: Informed Consent Form

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

View Document

Document Type: Annotated Case Report Form

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

View Document

Document Type: Clinical Study Report

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

View Document

Document Type: Study Protocol

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

View Document

Document Type: Individual Participant Data Set

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

View Document

Related Links

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Other Identifiers

111815

Identifier Type: -

Identifier Source: org_study_id