Immunogenicity and reactogenicity of a booster dose of GlaxoSmithKline Biologicals’ GSK2036874A vaccine in healthy toddlers.

• Register: EUCTR
• Last refreshed on: 20 June 2016
• Main ID: EUCTR2016-000645-31-Outside-EU/EEA
• Date of registration: 14/06/2016
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: Immunogenicity and reactogenicity of a booster dose of GlaxoSmithKline Biologicals’ GSK2036874A vaccine in healthy toddlers.
• Scientific title: A phase II, partially double-blind, randomised, controlled, single-centre study to assess the immunogenicity and reactogenicity of three different formulations of GSK Biologicals’ DTPw-HBV-IPV/Hib candidate vaccine compared to the Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to poliovirus vaccine-primed healthy toddlers aged 12-24 months. - DTPW-HBV-IPV=HIB-003
• Target sample size: 312
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000645-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Philippines

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion criteria

Inclusion criteria:
•A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
•Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
•Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (LAR)(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
•Written informed consent obtained from the parent(s)/LAR(s) 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: 312
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:
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2).
•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 (pharmaceutical product or device).
•History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Hib diseases.
•Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae dis-eases.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•A family history of congenital or hereditary immunodefi-ciency.
•Major congenital defects or serious chronic illness.
•History of neurologic disorders or seizures.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (including neomycin and polymyxin).
•Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
•Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
•Child in care.
•Occurrence of any of the following adverse event after a previous administration of a DTP vaccine:
-encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
-fever >= 40 °C (axillary temperature) within 48 hours of vaccination not due to another identifiable cause,
-collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination,
-convulsions with or without fever, occurring within 3 days of vaccination.
•Acute disease and/or fever at the time of enrolment.
-Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting.
-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
•Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Booster immunisation against poliomyelitis disease
MedDRA version: 19.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Trade Name: DTPw-HBV-IPV (full dose)/Hib
Product Name: DTPw-HBV-IPV(full dose)/Hib
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: -
Current Sponsor code: D
Other descriptive name: DIPHTHERIA TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: -
Current Sponsor code: T
Other descriptive name: TETANUS TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 60-
INN or Proposed INN: -
Current Sponsor code: Pw
Other descriptive name: WHOLE-CELL BORDETELLA PERTUSSIS (INACTIVATED)
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 4-
INN or Proposed INN: -
Current Sponsor code: HBsAg
Other descriptive name: HEPATITIS B SURFACE ANTIGEN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: -
Other descriptive name: POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN)
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 40-
INN or Proposed INN: -
Other descriptive name: POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN)
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 8-
INN or Proposed INN: -
Other descriptive name: POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN)
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 32-
INN or Proposed INN: -
Current Sponsor code: Hib
Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-

Trade Name: DTPw-HBV-IPV (1/2 dose)/Hib
Product Name: DTPw-HBV-IPV (1/2 dose)/Hib
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: -
Current Sponsor code: D
Other descriptive name: DIPHTHERIA TOXOID
Concentration

Primary Outcome(s)

Primary end point(s): •Immunogenicity with respect to the components of the study vaccines.
-Anti-poliovirus types 1, 2 and 3 seroprotection status.
-Anti-poliovirus types 1, 2 and 3 antibody titres.

Timepoint(s) of evaluation of this end point: -One month after booster vaccination
-Prior to and one month after booster vaccination.

Main Objective: •To demonstrate the non-inferiority of GSK Biologicals’ DTPw-HBV-IPV(3 doses)/Hib vaccine compared to Poliorix co-administered with Zilbrix/Hib,
-(full dose): in terms of seroprotection rates to the 3 poliovirus types and to demonstrate that the formulation induces at least a 2-fold increase in the geometric mean (GM) of the individual ratios (post- over pre-booster titres) for anti-poliovirus antibodies (Abs), 1 month after booster vaccination
-(1/2 dose): in terms of seroprotection rates to the 3 poliovirus types and to demonstrate that the formulation induces at least a 2-fold increase in the GM of the individual ratios (post- over pre-booster titres) for anti-poliovirus abs, 1 month after booster vaccination
-(1/3 dose): in terms of seroprotection rates to the 3 poliovirus types and to demonstrate that the formulation induces at least a 2-fold increase in the GM of the individual ratios (post- over pre-booster titres) for anti-poliovirus Abs, 1month after booster vaccination.

Secondary Objective: •To evaluate the immune response induced by three different formulations of GSK Biologicals’ DTPw-HBV-IPV/Hib vaccine in terms of seroprotection/seropositivity status, geometric mean concentrations/titres to all antigens, seroconversion status to the poliovirus antigens and in terms of booster response to the pertussis antigens, one month after booster administration.
•To evaluate the safety and reactogenicity of the study vaccines.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: -One month after booster vaccination
-Prior to and one month after booster vaccination.
-One month after booster vaccination.

Within 8-days (Day 0–Day 7) follow-up period after booster vaccination.
Within 31 days (Day 0-Day30) follow-up period after booster vaccination.

Secondary end point(s): •Immunogenicity with respect to the components of the study vaccines.
-Anti-poliovirus types 1, 2 and 3 seroprotection status, prior to booster vaccination.
-Anti-poliovirus types 1, 2 and 3 seroconversion status.
-Anti-diphtheria, anti-tetanus, anti-BPT, anti-HBs and anti-PRP seroprotection/seropositivity status and antibody concentrations.
-Booster response to Bordetella pertussis.
•Solicited local and general symptoms.
-Occurrence of solicited local and general symptoms.
•Unsolicited adverse events.
-Occurrence of unsolicited symptoms.
•Serious adverse events.
-Occurrence of SAEs from the booster dose up to study end.

Secondary ID(s)

113264

Source(s) of Monetary Support

GlaxoSmithKline Biologicals