This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Rotavirus Vaccines; Rotavirus Infection

Treatments: Biological: Prevenar 13; Biological: Rotarix; Biological: Pediarix; Biological: Hiberix

Study type: Interventional

Funder types: Industry

Identifiers

NCT03207750

201663

2016-003210-27 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age

Enrollment: 1,280 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects' parent(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 (42-90 days) of age at the time of the first study vaccination.
• Written or witnessed/thumb printed 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.

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 1), or planned use during the study period.

• Chronic administration (defined as more than 14 days in total) 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 within the period starting 30 days before the first dose of vaccine administration and ending at Visit 4, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, if administered at a site which is different from the sites used to administer the co-administered vaccines.

• 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.

• Very prematurely born infants (born ≤28 weeks of gestation).

• 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 Haemophilus type b (Hib), diphtheria, tetanus, pertussis, pneumococcus, RV and/or poliovirus.

• Previous confirmed occurrence of RV GE, Hib, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B and/or polio disease.

• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

• 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.

• History of any neurological disorders or seizures.

• History of Severe combined immunodeficiency (SCID).

• 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 without fever may be enrolled at the discretion of the investigator.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,280 participants in 2 patient groups

HRV PCV-free Liq Group

Experimental group

Description:

Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.

Treatment:

Biological: Hiberix

Biological: Pediarix

Biological: Rotarix

Biological: Prevenar 13

HRV Lyo Group

Active Comparator group

Description:

Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).

Treatment:

Biological: Hiberix

Biological: Pediarix

Biological: Rotarix

Biological: Prevenar 13