Evaluation of Immunogenicity and Safety of the Diphtheria... | NCT02907216

ID	Type	Description	Link
2014-005282-78	EudraCT Number

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Squarekids	Biological	Three doses administered subcutaneously in the upper arm or thigh	Co-administration Group Staggered Group

Measure	Description	Time Frame
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)

Measure	Description	Time Frame
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.

Eligibility Module

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.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Chiba		274-0063	Japan
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
30785851	Background	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.

ID	Title	Description
FG000	Co-administration Group	Subjects aged 6 to 12 weeks who received 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 was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 3, 2016	May 15, 2018

ID	Title	Description
BG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
BG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000147 BG001145 BG002292

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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).

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.

Posted

Number

95% Confidence Interval

Percentage of subjects

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

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Units	Counts
Participants	OG000141 OG001138

Title

Denominators

Categories

Anti-D antibody ≥ 0.1 IU/mL

- ParticipantsOG000141
- ParticipantsOG001137

Title	Measurements
	OG000100(97.4 to 100)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-D antibody concentration ≥ 0.1 IU/mL.					Difference-Seroprotective concentration	0			2-Sided	95	-2.66	2.74			The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.		Non-Inferiority	Criteria for non-inferiority: The Lower Limit (LL) of the standardised asymptotic 95% Confidence Interval (CI) on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-D antibodies should be ≥ -10%.

Primary

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.

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.

Posted

Number

95% Confidence Interval

Percentage of subjects

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

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Primary

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).

Posted

Number

95% Confidence Interval

Percentage of subjects

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

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Secondary

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.

Analysis was performed on HRV immunogenicity sub-cohort of 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.

Posted

Number

95% Confidence Interval

Percentage 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)

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group

Secondary

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.

Posted

Geometric Mean

95% Confidence Interval

U/mL

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)

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Secondary

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.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

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

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Secondary

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.

Posted

Geometric Mean

95% Confidence Interval

Titer

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

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Secondary

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.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

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

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Secondary

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.

Analysis was performed on the Total Vaccinated cohort (TVC) which included all subjects with at least one dose of the study vaccines administration documented.

Posted

Count of Participants

Participants

During the 8-day (Days 0-7) follow-up period after each dose of liquid HRV vaccine

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Secondary

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.

Analysis was performed on the TVC which included all subjects with at least one dose of the study vaccines administration documented.

Posted

Count of Participants

Participants

During the 8-day (Days 0-7) follow-up period after first dose of DTP-IPV vaccine

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Units

Secondary

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.

Analysis was performed on the TVC which included all subjects with at least one dose of the study vaccines administration documented.

Posted

Count of Participants

Participants

During the 8-day (Days 0-7) follow-up period after first dose of DTP-IPV vaccine

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Secondary

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.

Analysis was performed on the TVC which included all subjects with at least one dose of the study vaccines administration documented.

Posted

Count of Participants

Participants

During the 31-day (Days 0-30) follow-up period after each dose of liquid HRV vaccine

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Secondary

Number of Subjects With Any Unsolicited AE After First Dose of DTP-IPV Vaccine

Analysis was performed on the TVC which included all subjects with at least one dose of the study vaccines administration documented.

Posted

Count of Participants

Participants

During the 31-day (Days 0-30) follow-up period after first dose of DTP-IPV vaccine

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Secondary

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.

Analysis was performed on the TVC which included all subjects with at least one dose of the study vaccines administration documented.

Posted

Count of Participants

Participants

During the entire study period (from Day 0 to Month 5)

ID	Title	Description
OG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
OG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anal abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0011 events1 affected145 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Asteatosis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0012 events2 affected145 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Bronchiolitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0012 events2 affected145 at risk
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected147 at risk EG0011 events1 affected145 at risk
Candida infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0012 events2 affected145 at risk
Conjunctivitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected147 at risk EG0014 events4 affected145 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected147 at risk EG0013 events3 affected145 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG00095 events69 affected147 at risk EG00185 events72 affected145 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG00035 events27 affected147 at risk EG00137 events31 affected145 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0011 events1 affected145 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected147 at risk EG0011 events1 affected145 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00052 events41 affected147 at risk EG00161 events50 affected145 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected147 at risk EG0010 events0 affected145 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0009 events9 affected147 at risk EG00110 events10 affected145 at risk
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected147 at risk EG0010 events0 affected145 at risk
Eczema eyelids	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Eczema infantile	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG00014 events13 affected147 at risk EG00111 events11 affected145 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0004 events3 affected147 at risk EG0011 events1 affected145 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Exanthema subitum	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0011 events1 affected145 at risk
Excessive cerumen production	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0011 events1 affected145 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Eye discharge	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected147 at risk EG0011 events1 affected145 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Impetigo	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected147 at risk EG0011 events1 affected145 at risk
Influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0012 events2 affected145 at risk
Injection site erythema	General disorders	MedDRA 20.1	Systematic Assessment	EG00085 events85 affected147 at risk EG00184 events84 affected145 at risk
Injection site induration	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Injection site pain	General disorders	MedDRA 20.1	Systematic Assessment	EG00032 events32 affected147 at risk EG00124 events24 affected145 at risk
Injection site swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG00050 events50 affected147 at risk EG00144 events44 affected145 at risk
Insomnia	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Irritability postvaccinal	General disorders	MedDRA 20.1	Systematic Assessment	EG000127 events93 affected147 at risk EG001162 events99 affected145 at risk
Lactose intolerance	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Leukoderma	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Metapneumovirus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0011 events1 affected145 at risk
Mucous stools	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0011 events1 affected145 at risk
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00026 events22 affected147 at risk EG00137 events33 affected145 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0011 events1 affected145 at risk
Ocular hyperaemia	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0011 events1 affected145 at risk
Otitis media	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0011 events1 affected145 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Peripheral swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected147 at risk EG0010 events0 affected145 at risk
Pharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected147 at risk EG0012 events1 affected145 at risk
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG00062 events54 affected147 at risk EG00180 events56 affected145 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected147 at risk EG0010 events0 affected145 at risk
Respiratory syncytial virus bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0011 events1 affected145 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0006 events6 affected147 at risk EG0015 events5 affected145 at risk
Rhinitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0011 events1 affected145 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0007 events7 affected147 at risk EG0016 events6 affected145 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0012 events2 affected145 at risk
Skin induration	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Skin infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Somnolence	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG00037 events37 affected147 at risk EG00139 events39 affected145 at risk
Streptococcal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0011 events1 affected145 at risk
Superficial injury of eye	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected147 at risk EG0011 events1 affected145 at risk
Swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0006 events4 affected147 at risk EG0014 events2 affected145 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG00021 events18 affected147 at risk EG00124 events20 affected145 at risk
Vaccination site induration	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected147 at risk EG0014 events4 affected145 at risk
Vaccination site swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected145 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00033 events24 affected147 at risk EG00138 events30 affected145 at risk

ID	Term
D004165	Diphtheria
D013742	Tetanus
D014917	Whooping Cough

ID	Term
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D003015	Clostridium Infections
D001885	Bordetella Infections
D016905	Gram-Negative Bacterial Infections
D012141	Respiratory Tract Infections
D012140	Respiratory Tract Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Co-administration Group	Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.	0	147	4	147	141	147
EG001	Staggered Group	Subjects aged 6 to 12 weeks who received 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 HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.	0	145	5	147	143	145