Immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids™ co-administered with GSK Biologicals’ human rotavirus (HRV) vaccine Rotarix™ (444563) in healthy infants.

• Register: EUCTR
• Last refreshed on: 22 August 2016
• Main ID: EUCTR2014-005282-78-Outside-EU/EEA
• Date of registration: 17/08/2016
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: Immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids™ co-administered with GSK Biologicals’ human rotavirus (HRV) vaccine Rotarix™ (444563) in healthy infants.
• Scientific title: A phase IV, randomised, open-label, controlled study to assess the immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids™ when co-administered with GSK Biologicals' oral live attenuated HRV liquid vaccine Rotarix™ in healthy Japanese infants aged 6 - 12 weeks at the time of the first dose of HRV vaccination. - ROTA-079
• Target sample size: 262
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005282-78
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no 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: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

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’ parent(s)/ Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator can and will comply with the requirements of the protocol.
• A male or female between, and including, 6 and 12 weeks of age at the time of the first dose of HRV vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born full-term as per the delivery records.
Are the trial subjects under 18? yes
Number of subjects for this age range: 262
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:
• Child in care.
• Use of any investigational or non-registered product other than the study vaccines within 30 days before the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (>= 0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of long-acting immune-modifying drugs at any time during the study period.
• Planned administration/administration of a vaccine not fore-seen by the study protocol within the period starting 30 days before the first dose of HRV vaccine administration and ending at Visit 7, with the exception of other routinely administered vaccines like PCV, Hib, BCG, hepatitis B, meningococcal vaccine and inactivated influenza vaccines, which are allowed at any time during the study, if administered at sites different from the sites used to administer the DPT-IPV vaccine.
• 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 vaccine/product.
• Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).
• History of IS.
• Family history of congenital or hereditary immunodeficiency.
• Any confirmed or suspected immunosuppressive or immu-nodeficient condition, based on medical history and physical examination.
• Major congenital defects or serious chronic illness.
• Previous vaccination against rotavirus, diphtheria, tetanus, pertussis and/ or poliovirus.
• Previous confirmed occurrence of RV GE, diphtheria, tetanus, pertussis, and/ or polio disease.
• GE within 7 days preceding the HRV vaccine administration.
• History of any reaction or hypersensitivity likely to be exac-erbated by any component of the HRV or DPT-IPV vaccines.
• Hypersensitivity to latex.
• History of any neurological disorders or seizures.
• History of SCID.
• Acute disease and/or fever at the time of enrollment.
- Fever is defined as temperature = 37.5°C /99.5°F on oral, axillary or tympanic setting, or = 38.0°C /100.4°F on rectal setting.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.



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

Health Condition(s) or Problem(s) studied

Active immunisation of infants against gastroenteritis (GE) due to rotavirus (RV).
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: Rotarix
Product Name: Rotarix
Pharmaceutical Form: 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-

Trade Name: Squarekids
Pharmaceutical Form: Solution for injection
INN or Proposed INN: -
Current Sponsor code: D
Other descriptive name: DIPHTHERIA TOXOID
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 14-
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: 9-
INN or Proposed INN: -
Current Sponsor code: PT
Other descriptive name: PERTUSSIS TOXOID
Concentration unit: U unit(s)
Concentration type: not less then
Concentration number: 4-
INN or Proposed INN: -
Other descriptive name: POLIOVIRUS TYPE 1 (INACTIVATED)
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 40-
INN or Proposed INN: -
Other descriptive name: POLIOVIRUS TYPE 2 (INACTIVATED)
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 8-
INN or Proposed INN: -
Other descriptive name: POLIOVIRUS TYPE 3 (INACTIVATED)
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 32-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: One month after administration of the third dose of the DPT-IPV vaccine (Visit 7).

Primary end point(s): Immunogenicity with respect to components of the DPT-IPV vaccine.
• anti-diphtheria antibody concentrations = 0.1 IU/mL,
• anti-tetanus antibody concentrations = 0.1 IU/mL,
• anti-PT and anti-FHA antibody concentrations = 10 EU/mL,
• anti-poliovirus serotypes 1, 2 and 3 antibody titre = 8 ED50

Main Objective: To demonstrate that the immunogenicity to the antigens contained in DPT-IPV vaccine is not impaired by the co-administration with GSK Biologicals' liquid HRV vaccine.

Secondary Objective: • To assess the immunogenicity of the liquid HRV vaccine in terms of serum anti-RV IgA antibody seropositivity and GMCs in a sub-cohort of subjects, 1 month after the sec-ond dose of the liquid HRV vaccine.
• To assess the immunogenicity to all the antigens contained in the DPT-IPV vaccine in terms of GMCs/ geometric mean antibody titres (GMTs), 1 month after the third dose of the DPT-IPV vaccine.
• To assess reactogenicity and safety after each dose of liquid HRV vaccine and first dose of DPT-IPV vaccine in terms of solicited symptoms during the 8-day follow-up period and unsolicited symptoms during the 31-day follow-up period.
• To assess safety in terms of serious adverse events (SAEs) from the first dose of study vaccine up to study end.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: • One month after the second dose of the liquid HRV vaccine.
• One month after the third dose of the DPT-IPV vaccine.
• During the 8-day (Days 0-7) follow-up period after each dose of liquid HRV vaccine.
• During the 8-day (Days 0-7) follow-up period after the first dose of DPT-IPV vaccine.
• During the 31-day (Days 0-30) follow-up period after each dose of the liquid HRV vaccine and the first dose of DPT-IPV vaccine.
• From the first dose of the study vaccine up to study end (Visit 7).

Secondary end point(s): • Serum anti-RV IgA antibody concentration greater and equal to 20 U/mL and seropositivity in a sub-cohort of subjects.
• Serum GMCs/GMTs for anti-diphtheria, anti-tetanus, anti-poliovirus serotypes 1, 2 and 3, anti-PT and anti-FHA antibodies.
• Occurrence of solicited general symptoms.
• Occurrence of solicited local and general symptoms.
• Occurrence of unsolicited AEs.
• Occurrence of SAEs.

Secondary ID(s)

114720

Source(s) of Monetary Support

GlaxoSmithKline Biologicals