Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants

NCT ID: NCT02907216

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-16
• Study Completion Date: 2017-05-29

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with or without the GSK Biologicals' liquid Rotarix (HRV) vaccine, in healthy Japanese infants aged 6 - 12 weeks. GSK Biologicals' liquid HRV vaccine Rotarix is licensed in Japan since 2011. Although the concomitant administration of GSK Biologicals' DTP-IPV vaccine has been evaluated during the clinical development of the HRV vaccine, the vaccine differed in composition and route of administration from the DPT-IPV vaccine Squarekids manufactured in Japan. Hence, as requested by the Japanese regulatory authorities, this post-licensure study will evaluate the immunogenicity of the DPT-IPV vaccine manufactured in Japan when co-administered with the liquid HRV vaccine

Detailed Description

This study is a phase IV, open-label, randomised, controlled, multi-centric, single-country study with two parallel groups. Subjects in the co-administration group will be administered the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. Subjects in the staggered group will be administered the DPT-IPV vaccine according to a 3, 4.5, 6 month schedule and the liquid HRV vaccine according to a 2, 3.5 month schedule. The intended duration of the study, per subject, is 5 months.

A sub-cohort of subjects (HRV Immunogenicity sub-cohort) from both the study groups will include the first 73 subjects enrolled into the study to assess the serum anti-RV IgA seropositivity and Geometric Mean Concentrations (GMC).

Conditions

Rotavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Co-administration Group

Subjects aged 6 to 12 weeks who receive the Squarekids vaccine (diphtheria, tetanus, pertussis and inactivated poliovirus \[DPT-IPV\] vaccine) according to a 3, 4, 6 month schedule and the liquid Rotarix vaccine (oral live attenuated human rotavirus \[HRV\] vaccine) according to a 2, 3 month schedule. The HRV vaccine is administered orally while the DTP-IPV vaccine is administered subcutaneously in the upper arm or upper thigh.

Group Type: EXPERIMENTAL

Squarekids

Intervention Type: BIOLOGICAL

Three doses administered subcutaneously in the upper arm or thigh

Rotarix

Intervention Type: BIOLOGICAL

Two doses administered orally

Staggered Group

Subjects aged 6 to 12 weeks who receive the Squarekids vaccine (diphtheria, tetanus, pertussis and inactivated poliovirus \[DPT-IPV\] vaccine) according to a 3, 4.5, 6 month schedule and the liquid Rotarix vaccine (oral live attenuated human rotavirus \[HRV\] vaccine) according to a 2, 3.5 month schedule. The HRV vaccine is administered orally while the DTP-IPV vaccine is administered subcutaneously in the upper arm or upper thigh.

Group Type: ACTIVE_COMPARATOR

Squarekids

Intervention Type: BIOLOGICAL

Three doses administered subcutaneously in the upper arm or thigh

Rotarix

Intervention Type: BIOLOGICAL

Two doses administered orally

Interventions

Squarekids

Three doses administered subcutaneously in the upper arm or thigh

Intervention Type: BIOLOGICAL

Rotarix

Two doses administered orally

Intervention Type: BIOLOGICAL

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.
• A male or female between, and including, 6 and 12 weeks of age at the time of the first dose of HRV vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born full-term as per the delivery records.

Exclusion Criteria

• Child in care.
• Use of any investigational or non-registered product other than the study vaccines within 30 days before 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 (≥ 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 fore-seen by the study protocol within the period starting 30 days before the first dose of HRV vaccine administration and ending at Visit 7, with the exception of other routinely administered vaccines like PCV, Hib, BCG, hepatitis B, meningococcal vaccine and inactivated influenza vaccines, which are allowed at any time during the study, if administered at sites different from the sites used to administer the DPT-IPV vaccine.
• 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 rotavirus, diphtheria, tetanus, pertussis and/ or poliovirus.
• Previous confirmed occurrence of RV GE, diphtheria, tetanus, pertussis, and/ or polio disease.
• GE within 7 days preceding the HRV vaccine administration.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the HRV or DPT-IPV vaccines.
• Hypersensitivity to latex.
• History of any neurological disorders or seizures.
• History of SCID.
• Acute disease and/or fever at the time of enrollment.

• Fever is defined as temperature ≥ 37.5°C /99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C /100.4°F on rectal setting.
• Subjects with a minor illness 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

Chiba, , Japan

GSK Investigational Site

Chiba, , Japan

GSK Investigational Site

Okayama, , 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

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

Countries

Japan

References

Gillard P, Tamura T, Kuroki H, Morikawa Y, Moerman L, Parra J, Kitamura Y, Mihara K, Okamasa A. Immunogenicity and safety of the diphtheria, pertussis, tetanus and inactivated poliovirus vaccine when co-administered with the human rotavirus vaccine (Rotarix) in healthy Japanese infants: a phase IV randomized study. Hum Vaccin Immunother. 2019;15(4):800-808. doi: 10.1080/21645515.2018.1564441. Epub 2019 Feb 20.

Reference Type: BACKGROUND

PMID: 30785851 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-005282-78

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

114720

Identifier Type: -

Identifier Source: org_study_id