Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants

NCT02141204 | Completed Phase 3 Results

• 2 other identifiers: 1165662012-001875-35
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 8

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).

Conditions

Rotavirus

Keywords

Rotarix; HRV; Healthy infants; Liquid formulation; Lyophilized formulation; Human rotavirus vaccine

Outcome Measures

Primary Outcomes (1)

• Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations

  Serum anti-RV IgA antibody concentrations were expressed as geometric mean concentrations (GMCs).

  At Month 2

Secondary Outcomes (4)

• Percentage of Seroconverted Subjects for Anti-RV IgA Antibodies

  At Month 2

• Number of Subjects With Any Solicited General Adverse Events (AEs)

  During the 8-day follow-up period after each vaccination (vaccines administered at Day 1 and Month 1)

• Number of Subjects With Any Unsolicited AEs

  During the 31-day follow-up period across doses (vaccines administered at Day 1 and Month 1)

• Number of Subjects With Any Serious Adverse Events (SAEs)

  Throughout the study period (from Day 1 up to Month 2)

Study Arms (2)

HRV Liq Group

EXPERIMENTAL

Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.

Biological: HRV Liquid

HRV Lyo Group

ACTIVE COMPARATOR

Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.

Biological: HRV Lyophilized

Interventions

HRV Liquid BIOLOGICAL

Two doses administered orally according to a 0, 1-month schedule.

HRV Liq Group

HRV Lyophilized BIOLOGICAL

Two doses administered orally according to a 0, 1-month schedule.

HRV Lyo Group

Eligibility Criteria

• Age: 6 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Bangalore, 560002, India

Location

GSK Investigational Site

Kolkata, 700017, India

Location

GSK Investigational Site

Ludhiana, 141 008, India

Location

GSK Investigational Site

Mumbai, 400012, India

Location

GSK Investigational Site

Pune, 411 011, India

Location

GSK Investigational Site

Pune, India

Location

GSK Investigational Site

Vellore, 632002, India

Location

GSK Investigational Site

Vellore, 632004, India

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 19, 2014
• Study Start: February 20, 2019
• Primary Completion: December 28, 2019
• Study Completion: December 28, 2019
• Last Updated: December 9, 2020
• Results First Posted: December 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

IN (8)