Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants

Infections, Rotavirus Clinical Trial

Official title:

Reactogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine 444563, in Healthy Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107587
• Other study ID #: 113518
• Status: Completed
• Phase: Phase 1
• First received: April 20, 2010
• Last updated: May 18, 2017
• Start date: April 13, 2010
• Est. completion date: June 28, 2010

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 28, 2010
• Est. primary completion date: June 28, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 16 Weeks

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.

• A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccination.

• Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

• Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

• Child in care.

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding 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, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).

• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the human rotavirus vaccine or placebo except for the routine childhood vaccinations.

• Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

• A family history of congenital or hereditary immunodeficiency.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Major congenital defects or serious chronic illness.

• Acute disease at the time of enrolment..

• History of confirmed rotavirus gastroenteritis.

• Gastroenteritis within 7 days preceding the study vaccine or placebo administration.

• Previous vaccination with rotavirus vaccine or planned to use during the study period.

• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

• 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.

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

Biological:
• GSK Biologicals' human rotavirus vaccine 444563
Oral, two doses.
• Placebo
Oral, two doses.

Locations

Country	Name	City	State
China	GSK Investigational Site	Liucheng County	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

References & Publications (1)

Li RC, Li YP, Mo ZJ, Luo D, Huang T, Kong JL, Wang LH, Song NS, Liu A, Zhang H, Liao X, Karkada N, Han HH. Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China: randomized, double-blind, placebo-controlled Phase I studies. Hum Vaccin Immunother. 2013 Aug;9(8):1638-42. doi: 10.4161/hv.25076. Epub 2013 Jun 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of grade 3 solicited adverse events.		Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.
Secondary	Occurrence of each solicited adverse event.		Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.
Secondary	Occurrence of unsolicited adverse events.		Within the 31-day (Day 0 - 30) follow-up period after any vaccine dose.
Secondary	Occurrence of serious adverse events.		Throughout the study period (Day 0 to Month 2).

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 113518 can be found on the GSK Clinical Study Register