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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

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ClinicalTrials.gov Identifier: NCT02907216
Recruitment Status : Completed
First Posted : September 20, 2016
Results First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Rotavirus Vaccines Biological: Squarekids Biological: Rotarix Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : September 16, 2016
Actual Primary Completion Date : May 29, 2017
Actual Study Completion Date : May 29, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Biological: Squarekids
Three doses administered subcutaneously in the upper arm or thigh

Biological: Rotarix
Two doses administered orally

Active Comparator: 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.
Biological: Squarekids
Three doses administered subcutaneously in the upper arm or thigh

Biological: Rotarix
Two doses administered orally




Primary Outcome Measures :
  1. Percentage of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to (≥) the Cut-off Value [ Time Frame: One month post third dose of DTP-IPV vaccine (At Month 5) ]
    Percentage of subjects with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

  2. Percentage of Subjects With Anti-pertussis Toxoid (Anti-PT) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibody Concentrations ≥ the Cut-off Value [ Time Frame: One month post third dose of DTP-IPV vaccine (At Month 5) ]
    Percentage of subjects with anti-PT and anti-FHA antibody concentrations ≥ 10 IU/mL.

  3. Percentage of Subjects With Anti-poliovirus Serotypes 1, 2 and 3 (Anti-polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Value [ Time Frame: One month post third dose of DTP-IPV vaccine (At Month 5) ]
    Percentage of subjects with anti-polio 1, 2 and 3 antibody titers ≥ 8 estimated doses 50% (ED50).


Secondary Outcome Measures :
  1. Percentage of Seropositive Subjects for Serum Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies in a Sub-cohort of Subjects [ Time Frame: 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) ]
    A seropositive subject for serum anti-RV IgA antibodies was defined as a subject with anti-RV IgA antibody concentration ≥ the seropositivity cut-off value of 20 units per milliliter (U/mL). Immunogenicity of the liquid HRV vaccine in terms of serum anti-RV IgA antibody seropositivity was assessed in a sub-cohort of subjects (HRV immunogenicity sub-cohort) which included the first 73 subjects enrolled into each of the 2 study groups.

  2. Serum Anti-RV IgA Antibody Concentration to Evaluate Immunogenicity in a Sub-cohort of Subjects [ Time Frame: 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) ]
    Concentration of serum anti-RV IgA antibody was assessed by Enzyme Linked Immunosorbent Assay (ELISA) and expressed as geometric mean concentration (GMC) in U/mL. The assay cut-off was 20 U/mL. Immunogenicity of the liquid HRV vaccine in terms of serum anti-RV IgA antibody GMC was assessed in a sub-cohort of subjects (HRV immunogenicity sub-cohort) which included the first 73 subjects enrolled into each of the 2 study groups.

  3. Anti-D and Anti-T Antibody Concentrations to Evaluate Immunogenicity [ Time Frame: One month post third dose of DTP-IPV vaccine (At Month 5) ]
    Concentrations of anti-D and anti-T antibodies were assessed by ELISA, presented as GMCs and expressed in IU/mL. The assay cut-off for anti-D and anti-T antibody concentrations was 0.1 IU/mL.

  4. Anti-polio 1, 2 and 3 Antibodies Titers to Evaluate Immunogenicity [ Time Frame: One month post third dose of DTP-IPV vaccine (At Month 5) ]
    Titers of anti-polio 1, 2 and 3 were assessed by Neutralisation Assay (NEU) and presented as Geometric Mean Titers (GMTs). The assay cut-off was 8 ED50.

  5. Anti-PT and Anti-FHA Antibody Concentrations to Evaluate Immunogenicity [ Time Frame: One month post third dose of DTP-IPV vaccine (At Month 5) ]
    Concentrations of anti-PT and anti-FHA antibodies were assessed by ELISA, presented as GMCs and expressed in IU/mL. The assay cut-offs for anti-PT and anti-FHA antibody concentrations were 2.693 IU/mL and 2.046 IU/mL respectively.

  6. Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine [ Time Frame: During the 8-day (Days 0-7) follow-up period after each dose of liquid HRV vaccine ]
    Assessed solicited general AEs were fever (defined as axillary temperature ≥ 37.5 degrees Celsius [°C]), irritability/fussiness, diarrhoea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.

  7. Number of Subjects With Any Solicited Local AEs After First Dose of DTP-IPV Vaccine [ Time Frame: During the 8-day (Days 0-7) follow-up period after first dose of DTP-IPV vaccine ]
    Assessed solicited local AEs were pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.

  8. Number of Subjects With Any Solicited General AEs After First Dose of DTP-IPV Vaccine [ Time Frame: During the 8-day (Days 0-7) follow-up period after first dose of DTP-IPV vaccine ]
    Assessed solicited general AEs were drowsiness, fever (defined as axillary temperature ≥ 37.5 °C), irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.

  9. Number of Subjects With Any Unsolicited AEs After Each Dose of Liquid HRV Vaccine [ Time Frame: During the 31-day (Days 0-30) follow-up period after each dose of liquid HRV vaccine ]
    Unsolicited AEs were defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.

  10. Number of Subjects With Any Unsolicited AE After First Dose of DTP-IPV Vaccine [ Time Frame: During the 31-day (Days 0-30) follow-up period after first dose of DTP-IPV vaccine ]
    Unsolicited AEs were defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.

  11. Number of Subjects With Any Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 to Month 5) ]
    Assessed SAEs included any untoward medical occurrence that resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.



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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907216


Locations
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Japan
GSK Investigational Site
Chiba, Japan, 274-0063
GSK Investigational Site
Chiba, Japan, 299-4503
GSK Investigational Site
Okayama, Japan, 701-0205
GSK Investigational Site
Saitama, Japan, 350-0001
GSK Investigational Site
Saitama, Japan, 360-0018
GSK Investigational Site
Tokyo, Japan, 146-0095
GSK Investigational Site
Tokyo, Japan, 157-0066
GSK Investigational Site
Tokyo, Japan, 167-0052
GSK Investigational Site
Tokyo, Japan, 183-0042
GSK Investigational Site
Tokyo, Japan, 190-0023
GSK Investigational Site
Tokyo, Japan, 206-0011
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] June 3, 2016
Statistical Analysis Plan  [PDF] September 12, 2016


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02907216     History of Changes
Other Study ID Numbers: 114720
2014-005282-78 ( EudraCT Number )
First Posted: September 20, 2016    Key Record Dates
Results First Posted: January 23, 2019
Last Update Posted: January 23, 2019
Last Verified: May 2018
Keywords provided by GlaxoSmithKline:
Healthy Japanese infants
Safety
Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) vaccine
Vaccination
Oral HRV liquid vaccine
Immunogenicity
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs