Clinical trial NCT02141204: Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants
Official title: Immunogenicity and Safety Study of Two Different Formulations of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, Rotarix in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotavirus
Keywords: Rotarix
HRV
Healthy infants
Liquid formulation
Lyophilized formulation
Human rotavirus vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-05-19
Enrollment: 451
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine when administered as a two-dose primary vaccination in healthy infants aged 6-10 weeks at dose one, with no previous history of rotavirus illness or vaccination.

While the lyophilized formulation of the HRV vaccine was licensed in India in February 2008, this study is conducted to generate additional clinical data for the liquid formulation of the HRV vaccine in India, as recommended by New Drug Advisory Committee on Vaccines (NDAC-Vaccines) of Drug Controller General of India (DCGI).


Eligibility 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.
* Written informed consent obtained from the parent(s)/ LAR(s) of the subject prior to performing any study specific procedure.
* A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Birth weight \>2000 grams.

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 vaccine (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 any chronic drug therapy to be continued 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, according to the local immunization practice.
* 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.
* History of confirmed RV GE.
* Previous vaccination against RV.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, (including Severe Combined Immunodeficiency \[SCID\] disorder) based on medical history and physical examination.
* Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
* History of IS.
* Very prematurely born infants (born ≤28 weeks of gestation).
* Hypersensitivity to latex.
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of any neurological disorders or seizures.
* Acute disease and/or fever at the time of enrolment. This warrants deferral of vaccination.

  * 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 or the rectum.
  * Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
* 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 (e.g., infliximab).
* GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).

Primary outcomes:
measure: Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations
timeFrame: At Month 2
Secondary outcomes:
measure: Percentage of Seroconverted Subjects for Anti-RV IgA Antibodies
timeFrame: At Month 2
measure: Number of Subjects With Any Solicited General Adverse Events (AEs)
timeFrame: During the 8-day follow-up period after each vaccination (vaccines administered at Day 1 and Month 1)
measure: Number of Subjects With Any Unsolicited AEs
timeFrame: During the 31-day follow-up period across doses (vaccines administered at Day 1 and Month 1)
measure: Number of Subjects With Any Serious Adverse Events (SAEs)
timeFrame: Throughout the study period (from Day 1 up to Month 2)
Other outcomes:
Locations:
city: Bangalore
country: India
facility: GSK Investigational Site
city: Kolkata
country: India
facility: GSK Investigational Site
city: Ludhiana
country: India
facility: GSK Investigational Site
city: Mumbai
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Vellore,
country: India
facility: GSK Investigational Site
city: Vellore
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: