Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ Boostrix™ vaccine and the Chinese DT vaccine, when administered as booster vaccination in healthy children aged 6-8 years.

Phase 1

Conditions: Healthy volunteers (Immunisation against diphtheria, tetanus and pertussis)
MedDRA version: 19.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2016-000644-34-Outside-EU/EEA

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 660

Inclusion Criteria

All subjects must satisfy the following criteria at study entry:
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•A male or female between and including 6-8 years of age at the time of the booster vaccination.
•Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, as per Chinese recommendations.
•Written informed consent obtained from the parent/guardian of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 660
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding booster dose of study vaccine, or planned use during the study period.
•Concurrently participating in another clinical study or planned participation 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 (pharmaceutical product or device).
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
•Evidence of previous booster vaccination against diphtheria, tetanus or pertussis since administration of the fourth dose of DTP vaccine in the second year of life.
•Planned administration/administration of a vaccine (including routine paediatric vaccines) not foreseen by the study protocol during the period starting from 30 days be-fore booster dose of study vaccine and ending 30 days after (with the exception of OPV and hepatitis B vaccine).
•History of diphtheria, pertussis or tetanus diseases.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Known hypersensitivity to any component of the vaccine, or subject having shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines.
•Subjects having experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine.
•Subjects who have experienced transient thrombocyto-penia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
•Any of the following adverse events having occurred after previous administration of DTP vaccine.
Temperature >= 40.0 °C within 48 hours of vaccination.
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
Persistent, inconsolable crying lasting >= 3 hours occurring within 48 hours of vaccination.
Convulsions with or without fever occurring within 3 days of vaccination.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: One month after the booster dose:<br>To evaluate the immunogenicity of GSK Biologicals’ dTpa vaccine, in terms of antibody response to all vaccine antigens.<br>To assess the immunogenicity of the Chinese DT vaccine in terms of antibody response to diphtheria and tetanus toxoids<br>;Secondary Objective: To assess the safety and reactogenicity of GSK Biologicals’ dTpa vaccine and Chinese DT vaccine.;Timepoint(s) of evaluation of this end point: One month after booster vaccination in both groups,<br>•From pre-vaccination to post-vaccination time points<br>;Primary end point(s): •Anti-diphtheria toxoid antibody concentrations >= 0.1 IU/ml.<br>•Anti-tetanus toxoid antibody concentrations >= 0.1 IU/ml.<br>•Anti-pertussis toxoid (PT) and anti-filamentous haemagglutinin (FHA) antibody concentrations >= 20 El.U/ml.<br>•At least a four-fold increase in anti-pertactin (PRN) anti-body concentrations.<br>•Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Immunogenicity<br>•Anti-diphtheria and anti-tetanus toxoid antibody concentrations >= 0.1 IU/ml.<br>•Anti-PT, anti-FHA antibody concentrations >= 20 El.U/ml.<br>•Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations.<br>Safety and Reactogenicity<br>•Occurrence of solicited local and general symptoms.<br>•Occurrence of unsolicited symptoms<br>•Occurrence of serious adverse events (SAEs);Timepoint(s) of evaluation of this end point: Prior to booster vaccination in both groups<br><br>Within 4 days (Day 0-Day 3) after vaccination<br>Within 31 days (Day 0-Day 30) after vaccination.<br>Following the booster dose.