Study to evaluate efficacy, safety, reactogenicity and immunogenicity study of the lyophilised formulation of human rotavirus (HRV) vaccine 444563 in healthy Japanese infants.

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2015-001543-36-Outside-EU/EEA
• Date of registration: 22/06/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: Study to evaluate efficacy, safety, reactogenicity and immunogenicity study of the lyophilised formulation of human rotavirus (HRV) vaccine 444563 in healthy Japanese infants.
• Scientific title: A phase III, double-blind, randomised, placebo-controlled, multi-centre study in Japan to assess the efficacy, safety, reactogenicity and immunogenicity of the lyophilised formulation of GlaxoSmithKline (GSK) Biologicals’ live attenuated human rotavirus (HRV) vaccine, given as a two-dose primary vaccination course, in healthy infants previously uninfected with HRV. - Rota-056
• Target sample size: 765
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001543-36
• 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: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Japan

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion criteria

Inclusion criteria:
•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 infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vacci-nation.
•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.
•Born between a gestation period of 36 and 42 weeks inclusive.

Are the trial subjects under 18? yes
Number of subjects for this age range: 765
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 within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•History of use of experimental rotavirus vaccine.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
•A family history of congenital or hereditary immunodeficiency.
•Uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract that would pre-dispose for IS.
•Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature <37.5°C.) Temperature greater than or equal to these cut-offs warrants deferral of the vacci-nation pending recovery of the subject.
•Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Previous confirmed occurrence of RV GE.
•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).



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

Health Condition(s) or Problem(s) studied

Healthy volunteers

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

Intervention(s)

Trade Name: Rotarix
Pharmaceutical Form: Powder and solvent for oral suspension
INN or Proposed INN: -
Other descriptive name: HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED)
Concentration unit: log10 CCID50/dose log10 cell culture infective dose 50/dose
Concentration type: not less then
Concentration number: 6.0-
Pharmaceutical form of the placebo: Powder and solvent for oral suspension
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To determine if two doses of the lyophilised formulation of GSK Biologicals’ HRV vaccine can prevent any RV GE leading to a medical intervention and caused by the circulating wild-type RV strains during the efficacy follow-up period

Timepoint(s) of evaluation of this end point: During the efficacy follow-up period

Primary end point(s): Occurrence of any RV GE leading to medical intervention and caused by the circulating wild-type RV strains.

Secondary Objective: •To assess the efficacy of two doses of the HRV vaccine against any & severe RV GE leading to a medical intervention & caused by the circulating wild-type RV strains, wild-type G1 & non-G1 serotypes during the efficacy follow-up period.
•To assess efficacy of two doses of the HRV vaccine against hospitalisation due to RV GE caused by the circulating wild-type RV strains during the efficacy follow-up period.
•To assess vaccine efficacy against any and severe RV GE leading to a medical intervention & caused by the circulating wild-type RV strains during the period starting from Dose 1 up to Visit 5.
•To assess the safety and reactogenicity of two doses of HRV vaccine compared with placebo in terms of solicited symptoms, unsolicited adverse events (AEs) (31 days after each dose) and serious adverse events (SAEs) during the entire study.
•To explore the immunogenicity of the HRV vaccine in terms of serum anti-rotavirus IgA antibody concentrations one month after the second dose.

Secondary Outcome(s)

Secondary end point(s): Occurrence of severe RV GE leading to a medical intervention and caused by the circulating wild-type RV strains
Occurrence of any RV GE and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains of G1 serotype.
Occurrence of any RV GE and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains of non-G1 serotypes
Occurrence of hospitalisation due to RV GE caused by the circulating wild-type RV strains
Occurrence of any RV GE and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains.
Occurrence of each type of solicited symptom
Occurrence of unsolicited adverse events according to Medical Dictionary for Regulatory Activities (MedDRA) classification
Occurrence of serious adverse events
Serum anti-rotavirus IgA antibody concentration
Seroconversion in terms of anti-rotavirus IgA antibody

Timepoint(s) of evaluation of this end point: Severe, G1 and non-G1 RV GE: During the efficacy follow-up period
Wild-type RV GE: During the period starting from Dose 1 up to Visit 5
Solicited symptoms: Within the 8-day solicited follow-up period (Day 0 to Day 7) after each dose of HRV vaccine/placebo
Unsolicited symptoms: Within 31 days after any dose of HRV vaccine/Placebo (Day 0 to Day 30) after any dose of HRV vaccine/placebo
SAEs: Throughout the study period
Immunogenicity: At Visit 3

Secondary ID(s)

107625

Source(s) of Monetary Support

GlaxoSmithKline Biologicals