Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

NCT ID: NCT02914184

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1612 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-27
• Study Completion Date: 2018-11-26

Brief Summary

The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.

Detailed Description

• Experimental design: Phase IIIA, observer-blind, randomised (1:1:1:1), controlled, multi-centric, with four parallel groups and a staggered enrolment (Part A and Part B).
• Duration of the study: The intended duration of the study, per subject, will be approximately 7-8 months including the 6 months of extended safety follow-up period after the last dose of HRV vaccine.

• Epoch 001: Primary starting at Visit 1 (Day 0) and ending at the safety follow-up contact (Month 7-8).
• Primary completion Date (PCD): Visit 3 (Month 2-4).
• End of Study (EoS): Last testing results released of samples collected at Visit 3 or Last Subject Last Visit (LSLV) (Follow up contact at month 7-8).
• Study Groups:

• PCV-free HRV liquid formulation lot A (also referred to as Liq_A Group)
• PCV-free HRV liquid formulation lot B (also referred to as Liq_B Group)
• PCV-free HRV liquid formulation lot C (also referred to as Liq_C Group)
• GSK Biologicals' currently licensed lyophilised HRV formulation (also referred to as Lyo Group)
• Control:active control-GSK Biologicals' currently licensed lyophilised HRV vaccine
• Vaccination schedule: Two doses of HRV vaccine to be administered according to a 0, 1-2 month schedule according to the immunisation schedule for RV vaccine.

Note that as a result of internal change in data standards terminology, the study data collected was converted to cDISC and the statistical analysis plan was amended accordingly. "Day 0" in the study design was replaced by "Day 1"; consequently, "Day n" was replaced by "Day n+1". Thus, the time frames (Day 0, Day n) of Outcome Measures described in this study record are different to that denoted in the full protocol document posted.

Conditions

Infections, Rotavirus; Rotavirus Vaccines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Liq_A Group

All subjects will receive two doses of PCV-free HRV liquid formulation lot A, at 6 and 12 weeks of age

Group Type: EXPERIMENTAL

HRV PCV-free liquid vaccine

Intervention Type: BIOLOGICAL

Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

Liq_B Group

All subjects will receive two doses of PCV-free HRV liquid formulation lot B, at 6 and 12 weeks of age

Group Type: EXPERIMENTAL

HRV PCV-free liquid vaccine

Intervention Type: BIOLOGICAL

Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

Liq_C Group

All subjects will receive two doses of PCV-free HRV liquid formulation lot C, at 6 and 12 weeks of age

Group Type: EXPERIMENTAL

HRV PCV-free liquid vaccine

Intervention Type: BIOLOGICAL

Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

Lyo Group

All subjects will receive two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age

Group Type: ACTIVE_COMPARATOR

Rotarix

Intervention Type: BIOLOGICAL

Subjects will receive two doses of currently licensed lyophilised HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

Interventions

HRV PCV-free liquid vaccine

Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

Intervention Type: BIOLOGICAL

Rotarix

Subjects will receive two doses of currently licensed lyophilised HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Paramount, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

San Jose, California, United States

GSK Investigational Site

Nampa, Idaho, United States

GSK Investigational Site

Newton, Kansas, United States

GSK Investigational Site

Topeka, Kansas, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Cheraw, South Carolina, United States

GSK Investigational Site

North Charleston, South Carolina, United States

GSK Investigational Site

Layton, Utah, United States

GSK Investigational Site

Murray, Utah, United States

GSK Investigational Site

Orem, Utah, United States

GSK Investigational Site

Provo, Utah, United States

GSK Investigational Site

Syracuse, Utah, United States

GSK Investigational Site

Marshfield, Wisconsin, United States

GSK Investigational Site

San José, Provincia de San José, Costa Rica

GSK Investigational Site

San José, , Costa Rica

GSK Investigational Site

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Järvenpää, , Finland

GSK Investigational Site

Kokkola, , Finland

GSK Investigational Site

Oulu, , Finland

GSK Investigational Site

Pori, , Finland

GSK Investigational Site

Seinäjoki, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Turku, , Finland

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Tauberbischofsheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Schönau am Königssee, Bavaria, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

GSK Investigational Site

Bramsche, , Germany

GSK Investigational Site

Chiba, , Japan

GSK Investigational Site

Chiba, , Japan

GSK Investigational Site

Saitama, , Japan

GSK Investigational Site

Saitama, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Gangwon-do, , South Korea

GSK Investigational Site

Gyeonggido, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Málaga, Andalusia, Spain

GSK Investigational Site

Antequera/Málaga, , Spain

GSK Investigational Site

Castellon, , Spain

GSK Investigational Site

Castellon, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Marbella, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Hsinchu, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taoyuan District, , Taiwan

Countries

United States; Costa Rica; Finland; Germany; Japan; South Korea; Spain; Taiwan

References

Salamanca de la Cueva I, Pahud B, Huang LM, Leonardi M, Garcia-Sicilia J, Cespedes J, Abdelnour A, Tamura T, Kuroki H, Chiu NC, Virta M, Kokko S, Horn M, Panzer F, Kim JH, Jin L, Moerman L, Debacq C, Parra J, Ugarte A, Bi D; Rota-081 Study Group. Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants: a phase III, randomized trial. J Infect Dis. 2020 May 4;225(12):2106-15. doi: 10.1093/infdis/jiaa210. Online ahead of print.

Reference Type: BACKGROUND

PMID: 32365189 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-000598-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

115461

Identifier Type: -

Identifier Source: org_study_id