Trial Outcomes & Findings for Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants (NCT NCT02907216)

NCT ID: NCT02907216

Last Updated: 2019-11-25

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

292 participants

Primary outcome timeframe

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

Results posted on

2019-11-25

Participant Flow

Out of the 292 subjects enrolled in the study, the first 73 subjects enrolled into each of the 2 study groups (total of 146 subjects) were allocated to the HRV immunogenicity sub-cohort to evaluate immunogenicity of the liquid HRV vaccine.

Participant milestones

Participant milestones
Measure	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.	Staggered 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, 4.5, 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 was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
Overall Study STARTED	147	145
Overall Study COMPLETED	146	144
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Staggered 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, 4.5, 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 was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
Overall Study No benefit to be obtained by continuing	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Co-administration Group n=147 Participants 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.	Staggered Group n=145 Participants 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.	Total n=292 Participants Total of all reporting groups
Age, Continuous Weeks of age at Dose 1 of HRV	9.5 Weeks STANDARD_DEVIATION 1.1 • n=5 Participants	9.4 Weeks STANDARD_DEVIATION 1.1 • n=7 Participants	9.5 Weeks STANDARD_DEVIATION 1.1 • n=5 Participants
Age, Continuous Weeks of age at Dose 2 of HRV	14 Weeks STANDARD_DEVIATION 1.1 • n=5 Participants	15.5 Weeks STANDARD_DEVIATION 1.3 • n=7 Participants	14.7 Weeks STANDARD_DEVIATION 1.4 • n=5 Participants
Age, Continuous Weeks of age at Dose 1 of DPT-IPV	14 Weeks STANDARD_DEVIATION 1.1 • n=5 Participants	13.9 Weeks STANDARD_DEVIATION 1 • n=7 Participants	14 Weeks STANDARD_DEVIATION 1.1 • n=5 Participants
Age, Continuous Weeks of age at Dose 2 of DPT-IPV	18.5 Weeks STANDARD_DEVIATION 1.2 • n=5 Participants	20 Weeks STANDARD_DEVIATION 1.4 • n=7 Participants	19.2 Weeks STANDARD_DEVIATION 1.5 • n=5 Participants
Age, Continuous Weeks of age at Dose 3 of DPT-IPV	23.7 Weeks STANDARD_DEVIATION 1.8 • n=5 Participants	25 Weeks STANDARD_DEVIATION 1.9 • n=7 Participants	24.4 Weeks STANDARD_DEVIATION 1.9 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	65 Participants n=7 Participants	137 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	80 Participants n=7 Participants	155 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	147 Participants n=5 Participants	145 Participants n=7 Participants	292 Participants n=5 Participants

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Outcome measures
Measure	Co-administration Group n=141 Participants 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.	Staggered Group n=138 Participants 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.
Percentage of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to (≥) the Cut-off Value Anti-D antibody ≥ 0.1 IU/mL	100 Percentage of subjects Interval 97.4 to 100.0	100 Percentage of subjects Interval 97.3 to 100.0
Percentage of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to (≥) the Cut-off Value Anti-T antibody ≥ 0.1 IU/mL	98.6 Percentage of subjects Interval 95.0 to 99.8	99.3 Percentage of subjects Interval 96.0 to 100.0

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Outcome measures
Measure	Co-administration Group n=141 Participants 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.	Staggered Group n=138 Participants 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.
Percentage of Subjects With Anti-pertussis Toxoid (Anti-PT) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibody Concentrations ≥ the Cut-off Value Anti-PT antibody ≥ 10 IU/mL	95.7 Percentage of subjects Interval 91.0 to 98.4	92.8 Percentage of subjects Interval 87.1 to 96.5
Percentage of Subjects With Anti-pertussis Toxoid (Anti-PT) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibody Concentrations ≥ the Cut-off Value Anti-FHA antibody ≥ 10 IU/mL	100 Percentage of subjects Interval 97.4 to 100.0	100 Percentage of subjects Interval 97.4 to 100.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Co-administration Group n=140 Participants 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.	Staggered Group n=137 Participants 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.
Percentage of Subjects With Anti-poliovirus Serotypes 1, 2 and 3 (Anti-polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Value Anti-Polio 3 antibody ≥ 8 ED50	100 Percentage of subjects Interval 97.2 to 100.0	99.2 Percentage of subjects Interval 95.6 to 100.0
Percentage of Subjects With Anti-poliovirus Serotypes 1, 2 and 3 (Anti-polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Value Anti-Polio 1 antibody ≥ 8 ED50	100 Percentage of subjects Interval 97.4 to 100.0	100 Percentage of subjects Interval 97.3 to 100.0
Percentage of Subjects With Anti-poliovirus Serotypes 1, 2 and 3 (Anti-polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Value Anti-Polio 2 antibody ≥ 8 ED50	100 Percentage of subjects Interval 97.2 to 100.0	100 Percentage of subjects Interval 97.1 to 100.0

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Co-administration Group n=69 Participants 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.	Staggered Group n=67 Participants 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.
Percentage of Seropositive Subjects for Serum Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies in a Sub-cohort of Subjects	92.8 Percentage of subjects Interval 83.9 to 97.6	92.5 Percentage of subjects Interval 83.4 to 97.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Co-administration Group n=69 Participants 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.	Staggered Group n=67 Participants 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.
Serum Anti-RV IgA Antibody Concentration to Evaluate Immunogenicity in a Sub-cohort of Subjects	350.1 U/mL Interval 223.3 to 548.8	362.5 U/mL Interval 251.0 to 523.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Co-administration Group n=141 Participants 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.	Staggered Group n=138 Participants 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.
Anti-D and Anti-T Antibody Concentrations to Evaluate Immunogenicity Anti-D antibody	5.4 IU/mL Interval 4.9 to 6.0	6 IU/mL Interval 5.5 to 6.6
Anti-D and Anti-T Antibody Concentrations to Evaluate Immunogenicity Anti-T antibody	1.6 IU/mL Interval 1.3 to 2.0	2 IU/mL Interval 1.7 to 2.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Co-administration Group n=140 Participants 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.	Staggered Group n=137 Participants 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.
Anti-polio 1, 2 and 3 Antibodies Titers to Evaluate Immunogenicity Anti-Polio 1 antibody	404.7 Titer Interval 341.4 to 479.8	427.9 Titer Interval 359.3 to 509.6
Anti-polio 1, 2 and 3 Antibodies Titers to Evaluate Immunogenicity Anti-Polio 3 antibody	436.3 Titer Interval 365.6 to 520.7	409.8 Titer Interval 330.8 to 507.5
Anti-polio 1, 2 and 3 Antibodies Titers to Evaluate Immunogenicity Anti-Polio 2 antibody	371 Titer Interval 307.0 to 448.5	470.6 Titer Interval 388.3 to 570.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Co-administration Group n=141 Participants 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.	Staggered Group n=138 Participants 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.
Anti-PT and Anti-FHA Antibody Concentrations to Evaluate Immunogenicity Anti-FHA antibody	83.7 IU/mL Interval 74.8 to 93.6	97.2 IU/mL Interval 86.7 to 109.0
Anti-PT and Anti-FHA Antibody Concentrations to Evaluate Immunogenicity Anti-PT antibody	31.5 IU/mL Interval 28.4 to 34.9	31.5 IU/mL Interval 27.9 to 35.6

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Co-administration Group n=147 Participants 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.	Staggered Group n=145 Participants 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.
Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine Any Vomiting, Dose 1	19 Participants	19 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine Any Loss of Appetite, Dose 1	18 Participants	10 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine Any Diarrhoea, Dose 2	22 Participants	26 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine Any Loss of Appetite, Dose 2	17 Participants	9 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine Any Cough, Dose 2	53 Participants	45 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine Any Fever, Dose 1	31 Participants	32 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine Any Irritability / Fussiness, Dose 1	66 Participants	62 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine Any Diarrhoea, Dose 1	30 Participants	32 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine Any Cough, Dose 1	41 Participants	40 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine Any Fever, Dose 2	31 Participants	15 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine Any Irritability / Fussiness, Dose 2	61 Participants	41 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine Any Vomiting, Dose 2	14 Participants	18 Participants

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Co-administration Group n=147 Participants 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.	Staggered Group n=144 Participants 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.
Number of Subjects With Any Solicited Local AEs After First Dose of DTP-IPV Vaccine Any Pain	32 Participants	24 Participants
Number of Subjects With Any Solicited Local AEs After First Dose of DTP-IPV Vaccine Any Redness (mm)	85 Participants	84 Participants
Number of Subjects With Any Solicited Local AEs After First Dose of DTP-IPV Vaccine Any Swelling (mm)	50 Participants	44 Participants

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Co-administration Group n=147 Participants 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.	Staggered Group n=144 Participants 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.
Number of Subjects With Any Solicited General AEs After First Dose of DTP-IPV Vaccine Any Drowiness	37 Participants	39 Participants
Number of Subjects With Any Solicited General AEs After First Dose of DTP-IPV Vaccine Any Fever	31 Participants	32 Participants
Number of Subjects With Any Solicited General AEs After First Dose of DTP-IPV Vaccine Any Irritability / Fussiness	61 Participants	59 Participants
Number of Subjects With Any Solicited General AEs After First Dose of DTP-IPV Vaccine Any Loss of Appetite	17 Participants	18 Participants

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Co-administration Group n=147 Participants 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.	Staggered Group n=145 Participants 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.
Number of Subjects With Any Unsolicited AEs After Each Dose of Liquid HRV Vaccine	88 Participants	81 Participants

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Co-administration Group n=147 Participants 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.	Staggered Group n=144 Participants 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.
Number of Subjects With Any Unsolicited AE After First Dose of DTP-IPV Vaccine	65 Participants	59 Participants

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Co-administration Group n=147 Participants 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.	Staggered Group n=145 Participants 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.
Number of Subjects With Any Serious Adverse Events (SAEs)	4 Participants	5 Participants

Adverse Events

Co-administration Group

Serious events: 4 serious events

Other events: 141 other events

Deaths: 0 deaths

Staggered Group

Serious events: 5 serious events

Other events: 143 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Co-administration Group n=147 participants at risk 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.	Staggered Group n=145 participants at risk；n=147 participants at risk 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.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/147 • 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).	0.68% 1/147 • Number of events 1 • 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).
Infections and infestations Nasopharyngitis	0.00% 0/147 • 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).	0.68% 1/147 • Number of events 1 • 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).
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/147 • 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).	0.68% 1/147 • Number of events 1 • 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).
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/147 • 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).	0.68% 1/147 • Number of events 1 • 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).
Infections and infestations Respiratory syncytial virus infection	1.4% 2/147 • Number of events 2 • 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).	0.00% 0/147 • 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).
Infections and infestations Viral infection	0.00% 0/147 • 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).	0.68% 1/147 • Number of events 1 • 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).
Respiratory, thoracic and mediastinal disorders Fibrinous bronchitis	0.68% 1/147 • Number of events 1 • 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).	0.00% 0/147 • 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).
Vascular disorders Kawasaki's disease	0.68% 1/147 • Number of events 1 • 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).	0.00% 0/147 • 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

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