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

NCT02907216 | Completed Phase 4 Results

• 2 other identifiers: 1147202014-005282-78
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 11

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

Conditions

Rotavirus

Keywords

Healthy Japanese infants; Safety; Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) vaccine; Vaccination; Oral HRV liquid vaccine; Immunogenicity

Outcome Measures

Primary Outcomes (3)

• Percentage of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to (≥) the Cut-off Value

  Percentage of subjects with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

  One month post third dose of DTP-IPV vaccine (At Month 5)

• Percentage of Subjects With Anti-pertussis Toxoid (Anti-PT) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibody Concentrations ≥ the Cut-off Value

  Percentage of subjects with anti-PT and anti-FHA antibody concentrations ≥ 10 IU/mL.

  One month post third dose of DTP-IPV vaccine (At Month 5)

• Percentage of Subjects With Anti-poliovirus Serotypes 1, 2 and 3 (Anti-polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Value

  Percentage of subjects with anti-polio 1, 2 and 3 antibody titers ≥ 8 estimated doses 50% (ED50).

  One month post third dose of DTP-IPV vaccine (At Month 5)

Secondary Outcomes (11)

• Percentage of Seropositive Subjects for Serum Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies in a Sub-cohort of Subjects

  One month post second dose of liquid HRV vaccine (At Month 2 for the Co-administration Group and at Month 2.5 for the Staggered Group)

• Serum Anti-RV IgA Antibody Concentration to Evaluate Immunogenicity in a Sub-cohort of Subjects

  One month post second dose of liquid HRV vaccine (At Month 2 for the Co-administration Group and at Month 2.5 for the Staggered Group)

• Anti-D and Anti-T Antibody Concentrations to Evaluate Immunogenicity

  One month post third dose of DTP-IPV vaccine (At Month 5)

• Anti-polio 1, 2 and 3 Antibodies Titers to Evaluate Immunogenicity

  One month post third dose of DTP-IPV vaccine (At Month 5)

• Anti-PT and Anti-FHA Antibody Concentrations to Evaluate Immunogenicity

  One month post third dose of DTP-IPV vaccine (At Month 5)

Study Arms (2)

Co-administration Group

EXPERIMENTAL

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.

Biological: Squarekids; Biological: Rotarix

Staggered Group

ACTIVE COMPARATOR

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.

Biological: Squarekids; Biological: Rotarix

Interventions

Squarekids BIOLOGICAL

Three doses administered subcutaneously in the upper arm or thigh

Co-administration Group; Staggered Group

Rotarix BIOLOGICAL

Two doses administered orally

Co-administration Group; Staggered Group

Eligibility Criteria

• Age: 6 Weeks - 12 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Chiba, 274-0063, Japan

Location

GSK Investigational Site

Chiba, 299-4503, Japan

Location

GSK Investigational Site

Okayama, 701-0205, Japan

Location

GSK Investigational Site

Saitama, 350-0001, Japan

Location

GSK Investigational Site

Saitama, 360-0018, Japan

Location

GSK Investigational Site

Tokyo, 146-0095, Japan

Location

GSK Investigational Site

Tokyo, 157-0066, Japan

Location

GSK Investigational Site

Tokyo, 167-0052, Japan

Location

GSK Investigational Site

Tokyo, 183-0042, Japan

Location

GSK Investigational Site

Tokyo, 190-0023, Japan

Location

GSK Investigational Site

Tokyo, 206-0011, Japan

Location

Related Publications (1)

• 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.

  PMID: 30785851 BACKGROUND

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

kap69137@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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 20, 2016
• Study Start: September 16, 2016
• Primary Completion: May 29, 2017
• Study Completion: May 29, 2017
• Last Updated: November 25, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• 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

JP (11)