Last updated: 11/03/2018 12:15:30
Immunogenicity and safety of Boostrix Polio vaccine as a booster dose in 5 to 6-year-old children.
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Immunogenicity and safety of GSK Biologicals’ dTpa-IPV vaccine (Boostrix Polio) as a booster dose in 5 to 6-year-old children.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibody concentrations
Timeframe: At Month 1, one month post-vaccination
Anti-poliovirus types 1, 2 and 3 antibody titres
Timeframe: At Month 1, one month post-vaccination
Number of seroprotected subjects against polio types 1, 2 and 3
Timeframe: At Month 1, one month post-vaccination
Number of seropositive subjects for anti-D and anti-T antibodies
Timeframe: At Month 1, one month post-vaccination
Secondary outcomes:
Number of seroprotected subjects against diphteria (D) and tetanus (T) antigens
Timeframe: At Month 1, one month post-vaccination
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
Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies
Timeframe: At Month 1, one month post-vaccination
Number of seropositive subjects for anti-measles, anti-mumps, anti-rubella and anti-varicella
Timeframe: At Month 1, one month post-vaccination
Anti-measles and anti-varicella antibody concentrations
Timeframe: At Month 1, one month post-vaccination
Anti-mumps antibody concentrations
Timeframe: At Month 1, one month post-vaccination
Anti-rubella antibody concentrations
Timeframe: At Month 1, one month post-vaccination
Number of subjects with booster responses to anti-D and anti-T
Timeframe: At Month 1, one month post-vaccination
Number of subjects with booster responses to anti-polio type 1, 2 and 3
Timeframe: At Month 1, one month post-vaccination
Number of subjects with booster responses to anti-PT, anti-FHA and anti-PRN
Timeframe: At Month 1, one month post-vaccination
Number of seroconverted subjects for anti-measles, anti-mumps, anti-rubella and anti-varicella
Timeframe: At Month 1, one month post-vaccination
Number of subjects with any solicited local symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period
Number of subjects with any solicited general symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) post-vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: During the whole study period (from Month 0 to Month 1)
Interventions:
Biological/vaccine: Boostrix Polio™ 711866
Biological/vaccine: Priorix Tetra TM 208136
Biological/vaccine: Tetravac TM
Enrollment:
303
Observational study model:
Not applicable
Primary completion date:
2009-18-11
Time perspective:
Not applicable
Clinical publications:
Ferrera G et al. (2012) 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. 8(3). [Epub ahead of print].
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.
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.
Medical condition
acellular pertussis, Tetanus, Diphtheria, Poliomyelitis
Product
SB208136, SB711866
Collaborators
Not applicable
Study date(s)
April 2009 to November 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
5 - 6 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
A male or female child of 5 and 6 years of age at the time of vaccination.
Exclusion criteria:
- 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;
- 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.
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.
Convulsions with or without fever, occurring within 3 days of vaccination.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-18-11
Actual study completion date
2009-18-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website