RotavirusPhase 4NCT02907216

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

A Phase 4 study testing Squarekids and Rotarix in people with Rotavirus, run by GlaxoSmithKline at 11 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for: Rotavirus
What is being tested?: Squarekids and Rotarix
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 292 participants
Where: 11 sitesJapan
Study dates: 16 Sep 2016to 29 May 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 12 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

Show all 22Show fewer

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.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Japan11 sites

GSK Investigational Site
Chiba, 274-0063
GSK Investigational Site
Chiba, 299-4503
GSK Investigational Site
Okayama, 701-0205
GSK Investigational Site
Saitama, 350-0001
GSK Investigational Site
Saitama, 360-0018
GSK Investigational Site
Tokyo, 146-0095
GSK Investigational Site
Tokyo, 157-0066
GSK Investigational Site
Tokyo, 167-0052
GSK Investigational Site
Tokyo, 183-0042
GSK Investigational Site
Tokyo, 190-0023
GSK Investigational Site
Tokyo, 206-0011

Other trials in Japan

About this study

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

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

Read the 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
Being tested: Squarekids, Rotarix
Keywords: Healthy Japanese infants, Safety, Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) vaccine, Vaccination, Oral HRV liquid vaccine, Immunogenicity
Medical subject headings: Diphtheria, Tetanus, Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SquarekidsBiological
Three doses administered subcutaneously in the upper arm or thigh
RotarixBiological
Two doses administered orally

Study groups in NCT02907216
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: Squarekids; Biological: Rotarix

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: One month post third dose of DTP-IPV vaccine (At Month 5)
Anti-polio 1, 2 and 3 Antibodies Titers to Evaluate Immunogenicity
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.
Measured: One month post third dose of DTP-IPV vaccine (At Month 5)
Anti-PT and Anti-FHA Antibody Concentrations to Evaluate Immunogenicity
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.
Measured: One month post third dose of DTP-IPV vaccine (At Month 5)
Number of Subjects With Any Solicited General Adverse Events (AEs) 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.
Measured: During the 8-day (Days 0-7) follow-up period after each dose of liquid HRV vaccine
Number of Subjects With Any Solicited Local AEs 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.
Measured: During the 8-day (Days 0-7) follow-up period after first dose of DTP-IPV vaccine
Number of Subjects With Any Solicited General AEs 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.
Measured: During the 8-day (Days 0-7) follow-up period after first dose of DTP-IPV vaccine
Number of Subjects With Any Unsolicited AEs 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.
Measured: During the 31-day (Days 0-30) follow-up period after each dose of liquid HRV vaccine
Number of Subjects With Any Unsolicited AE 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.
Measured: During the 31-day (Days 0-30) follow-up period after first dose of DTP-IPV vaccine
Number of Subjects With Any Serious Adverse Events (SAEs)
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.
Measured: During the entire study period (from Day 0 to Month 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 201629 May 2017

First posted20 Sep 2016 (estimated)
Study start16 Sep 2016
Primary completion29 May 2017
Study completion29 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for RotavirusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 292 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02907216
Sponsor's protocol ID: 114720
Other IDs: 2014-005282-78, 2014
Status last verified: Nov 2019
First submitted: 7 Sep 2016
Last updated: 25 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

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.
PubMed 30785851

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02907216
Acronym / sponsor ID: 114720
Conditions: Rotavirus
Keywords: Healthy Japanese infants, Safety, Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) vaccine, Vaccination, Oral HRV liquid vaccine, Immunogenicity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 292 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 16 Sep 2016 (actual)
Primary completion: 29 May 2017 (actual)
Study completion: 29 May 2017 (actual)
First posted: 20 Sep 2016 (estimated)
Results: Posted 23 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Co-administration Group	Experimental	Biological: Squarekids, Biological: RotarixSubjects 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.
Staggered Group	Active comparator	Biological: Squarekids, Biological: RotarixSubjects 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.

Who may qualify

Ages: 6 to 12 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (22 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SquarekidsThree doses administered subcutaneously in the upper arm or thigh	Biological	Co-administration Group, Staggered Group
RotarixTwo doses administered orally	Biological	Co-administration Group, Staggered Group

Primary outcome

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).
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.
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).

11 secondary outcomes

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)
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)
Anti-D and Anti-T Antibody Concentrations to Evaluate Immunogenicity
Time frame: One month post third dose of DTP-IPV vaccine (At Month 5)
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)
Anti-PT and Anti-FHA Antibody Concentrations to Evaluate Immunogenicity
Time frame: One month post third dose of DTP-IPV vaccine (At Month 5)
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
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
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
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
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
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 to Month 5)

Results and safety

Results posted to the registry on 23 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Co-administration Group	147	146
Staggered Group	145	144

Primary outcome: 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). Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Co-administration Group n = 141	Staggered Group n = 138
Anti-D antibody ≥ 0.1 IU/mL	100 (97.4 to 100)	100 (97.3 to 100)
Anti-T antibody ≥ 0.1 IU/mL	98.6 (95 to 99.8)	99.3 (96 to 100)

Co-administration Group vs Staggered Group: Difference-Seroprotective concentration: 0 (95% CI -2.66 to 2.74)
Co-administration Group vs Staggered Group: Difference-Seroprotective concentration: -0.69 (95% CI -4.39 to 2.71)

Population analysed: Analysis was performed on According-to-Protocol (ATP) cohort which included all subjects who complied with vaccination schedules of DPT-IPV and HRV vaccines, complied with the blood sampling schedule and for whom immunogenicity data was available for at least for one antigen of the DPT-IPV vaccine at Visit 7 (Month 5) sampling time point.

Primary outcome: 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). Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Co-administration Group n = 141	Staggered Group n = 138
Anti-PT antibody ≥ 10 IU/mL	95.7 (91 to 98.4)	92.8 (87.1 to 96.5)
Anti-FHA antibody ≥ 10 IU/mL	100 (97.4 to 100)	100 (97.4 to 100)

Co-administration Group vs Staggered Group: Difference-Seroprotective concentration: 2.99 (95% CI -2.7 to 9.12)
Co-administration Group vs Staggered Group: Difference-Seroprotective concentration: 0 (95% CI -2.66 to 2.72)

Population analysed: Analysis was performed on ATP cohort which included all subjects who complied with vaccination schedules of DPT-IPV and HRV vaccines, complied with the blood sampling schedule and for whom immunogenicity data was available for at least for one antigen of the DPT-IPV vaccine at Visit 7 (Month 5) sampling time point.

Primary outcome: 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). Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Co-administration Group n = 140	Staggered Group n = 137
Anti-Polio 1 antibody ≥ 8 ED50	100 (97.4 to 100)	100 (97.3 to 100)
Anti-Polio 2 antibody ≥ 8 ED50	100 (97.2 to 100)	100 (97.1 to 100)
Anti-Polio 3 antibody ≥ 8 ED50	100 (97.2 to 100)	99.2 (95.6 to 100)

Co-administration Group vs Staggered Group: Difference in seroprotective titer: 0 (95% CI -2.68 to 2.74)
Co-administration Group vs Staggered Group: Difference in seroprotective titer: 0 (95% CI -2.92 to 2.95)
Co-administration Group vs Staggered Group: Difference in seroprotective titer: 0.81 (95% CI -2.04 to 4.47)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local & general AEs were reported during the 8-day (Days 0-7) post-vaccination period following first dose of DTP-IPV vaccine; solicited general AEs were reported during the 8-day (Days 0-7) post-vaccination period following each dose of liquid HRV vaccine. Unsolicited AEs were reported the 31-day (Days 0-30) post-vaccination period after the first dose of DTP-IPV vaccine & after each dose of liquid HRV vaccine. SAEs were reported during the entire study period (from Day 0 to Month 5).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Co-administration Group	4 of 147 (2.7%)	141 of 147 (95.9%)	0 of 147
Staggered Group	5 of 147 (3.4%)	143 of 145 (98.6%)	0 of 145

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30785851Gillard 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.
Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)

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Rotavirus Infection of Children

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Squarekids and Rotarix in people with Rotavirus, run by GlaxoSmithKline at 11 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02907216, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.