Clinical trial NCT00871000: Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.
Official title: Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 5 to 6-year-old Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acellular Pertussis
Tetanus
Diphtheria
Poliomyelitis
Keywords: Boostrix Polio
dTpa-IPV
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 303
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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
* The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

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

Primary outcomes:
measure: Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
timeFrame: At Month 1, one month post-vaccination
measure: Anti-poliovirus Types 1, 2 and 3 Antibody Titres
timeFrame: At Month 1, one month post-vaccination
measure: Number of Seroprotected Subjects Against Polio Types 1, 2 and 3
timeFrame: At Month 1, one month post-vaccination
measure: Number of Seropositive Subjects for Anti-D and Anti-T Antibodies
timeFrame: At Month 1, one month post-vaccination
Secondary outcomes:
measure: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
timeFrame: At Month 1, one month post-vaccination
measure: Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
timeFrame: At Month 1, one month post-vaccination
measure: Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies
timeFrame: At Month 1, one month post-vaccination
measure: Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella
timeFrame: At Month 1, one month post-vaccination
measure: Anti-measles and Anti-varicella Antibody Concentrations
timeFrame: At Month 1, one month post-vaccination
measure: Anti-mumps Antibody Concentrations
timeFrame: At Month 1, one month post-vaccination
measure: Anti-rubella Antibody Concentrations
timeFrame: At Month 1, one month post-vaccination
measure: Number of Subjects With Booster Responses to Anti-D and Anti-T
timeFrame: At Month 1, one month post-vaccination
measure: Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3
timeFrame: At Month 1, one month post-vaccination
measure: Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN
timeFrame: At Month 1, one month post-vaccination
measure: Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella
timeFrame: At Month 1, one month post-vaccination
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the whole study period (from Month 0 to Month 1)
Other outcomes:
Locations:
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Novara
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Cagliari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Catania
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Modica (RG)
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Ragusa
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Vittoria (RG)
country: Italy
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.