Please select the eligibility criteria that correspond to the clinical trial below.
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 (GSK444563) in Healthy Infants
Brief Summary: The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with or without the GSK Biologicals' liquid Rotarix (HRV) vaccine, in healthy Japanese infants aged 6 - 12 weeks. GSK Biologicals' liquid HRV vaccine Rotarix is licensed in Japan since 2011. Although the concomitant administration of GSK Biologicals' DTP-IPV vaccine has been evaluated during the clinical development of the HRV vaccine, the vaccine differed in composition and route of administration from the DPT-IPV vaccine Squarekids manufactured in Japan. Hence, as requested by the Japanese regulatory authorities, this post-licensure study will evaluate the immunogenicity of the DPT-IPV vaccine manufactured in Japan when co-administered with the liquid HRV vaccine


Options:
A: Inclusion Criteria:

* Subjects' parent(s)/LAR(s) who, in the opinion of the investigator can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent(s)/LAR(s) (Legally acceptable representatives) of the subject prior to performing any study specific procedure.
* A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination.
* Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6 days).
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Child in care
* Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 0), 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 foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.
* 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 immunodeficient condition, based on medical history and physical examination.
* Major congenital defects or serious chronic illness.
* Previous vaccination against RV.
* Previous confirmed occurrence of RVGE.
* GE within 7 days preceding the study vaccine administration.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Hypersensitivity to latex.
* Acute disease and/or fever at the time of enrolment.

  * Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla and the rectum.
  * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
B: Inclusion Criteria:

* Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.

Exclusion Criteria:

* Allergic reaction to vaccine components;
* clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
* immunocompromised.
C: 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.

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 immunodeficient 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 exacerbated 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.
D: Inclusion Criteria:

* Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of \>2000g.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B.
* Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b.
* History of allergic disease
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
* Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination)
* Previous confirmed occurrence of RV GE.
* Household contact with an immunosuppressed individual or pregnant women.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period

Answer: C