Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

Infections, Rotavirus Clinical Trial

Official title:

Efficacy, Safety, Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480324
• Other study ID #: 107625
• Secondary ID: 2015-001543-36
• Status: Completed
• Phase: Phase 3
• Start date: June 19, 2007
• Est. completion date: November 21, 2009

Study information

• Verified date: December 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Description:

Combined diphtheria and tetanus toxoids and acellular pertussis (DTPa) and Hepatitis B (HBV) vaccines are allowed to be co-administered along with Rotarix vaccine/Placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 765
• Est. completion date: November 21, 2009
• Est. primary completion date: March 31, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 14 Weeks

Eligibility

Inclusion Criteria:

• Healthy male or female infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study

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

• Written informed consent obtained from the parent or guardian of the subject.

• Born between a gestation period of 36 and 42 weeks inclusive.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.

• History of use of experimental rotavirus vaccine.

• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.

• 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 (pharmaceutical product or device).

• Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception.

• Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator.

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

• Previous confirmed occurrence of RV GE.

• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).

• A family history of congenital or hereditary immunodeficiency.

• Acute disease at the time of enrolment.

• Gastroenteritis within 7 days preceding the study vaccine administration.

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

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections
• Rotavirus Vaccines

Intervention

Biological:
• Rotarix
Two-dose oral vaccination.
• Placebo
Two-dose oral administration.

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Kagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Miyagi
Japan	GSK Investigational Site	Miyagi
Japan	GSK Investigational Site	Nagano
Japan	GSK Investigational Site	Nagasaki
Japan	GSK Investigational Site	Niigata
Japan	GSK Investigational Site	Okayama
Japan	GSK Investigational Site	Okayama
Japan	GSK Investigational Site	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

References & Publications (4)

Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix™ in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8. — View Citation

Kawamura N et al. Efficacy of Human Rotavirus (G1P[8] strain) Vaccine (HRV) RIX4414 in Japanese Infants during the Two-year Efficacy Follow-up Period. Abstract presented at the 114th Annual Meeting of Japan Pediatric Society (JPS). Tokyo, Japan, 12-14 August 2011.

Kawamura N et al. Efficacy of human rotavirus vaccine RIX4414 in Japanese infants from 2 weeks post dose 2 up to data lock point. Abstract presented at the 28th meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.

Kawamura N, Tokoeda Y, Oshima M, Okahata H, Tsutsumi H, Van Doorn LJ, Muto H, Smolenov I, Suryakiran PV, Han HH. Efficacy, safety and immunogenicity of RIX4414 in Japanese infants during the first two years of life. Vaccine. 2011 Aug 26;29(37):6335-41. doi: 10.1016/j.vaccine.2011.05.017. Epub 2011 Jun 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains	Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.	From 2 weeks after Dose 2 up to 2 years of age
Secondary	Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains	A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).	From 2 weeks after Dose 2 up to 2 years of age
Secondary	Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type	Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.; Severe RV GE was defined as an episode of rotavirus gastroenteritis with score = 11 on a 20-point scoring system (Vesikari scoring system).	From 2 weeks after Dose 2 up to 2 years of age
Secondary	Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types	Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.; Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score = 11 on a 20-point scoring system (Vesikari scoring system).	From 2 weeks after Dose 2 up to 2 years of age
Secondary	Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains	Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.	From 2 weeks after Dose 2 up to 2 years of age
Secondary	Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains	Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.; Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score = 11 on a 20-point scoring system (Vesikari scoring system).	From Dose 1 up to 2 years of age
Secondary	Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration	Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs). Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL).	2 months after Dose 2
Secondary	Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies	Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration = 20 units (U)/milliliter (mL) in subjects initially (i.e. prior to the first dose of rotarix) seronegative.	2 months after Dose 2
Secondary	Number of Subjects Reporting Solicited Symptoms	Solicited symptoms assessed include cough, diarrhoea, fever, irritability, loss of appetite and vomiting.	During the 8-day follow-up period after each dose
Secondary	Number of Subjects Reporting Unsolicited Adverse Events (AEs)	Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	During the 31-day follow-up period after each dose
Secondary	Number of Subjects Reporting Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.	Up to 2 years of age

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