Gastroenteritis
Conditions
Keywords
Human rotavirus (HRV), Rotarix Porcine circovirus (PCV)-free liquid, Inactivated poliovirus vaccine (IPV), Healthy Chinese infants, Immunogenicity, Safety
Brief summary
The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese infants 6-10 weeks of age at the time of study enrolment.
Interventions
COMBINATION_PRODUCTHRV PCV-free
2 doses of HRV PCV-free vaccine are administered orally at Month 0.5 and Month 1.5 (Co-administration Group) and at Day 1 and Month 1 (Staggered Group), according to the immunization schedule for HRV vaccine licensed outside of China. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
COMBINATION_PRODUCTIPV
3 doses of IPV vaccine are administered intramuscularly at Month 0.5, Month 1.5 and Month 2.5 (Co-administration Group and Staggered Group), according to the recommended schedule for vaccination against poliovirus in China.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 10 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Participants' 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. * Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. * Healthy participants as established by medical history and clinical examination before entering into the study. * A male or female of Chinese origin, between and including, 6 and 10 weeks (42-76 days) of age at the time of study enrolment. * Born after a gestation period of 36 to 42 weeks inclusive.
Exclusion criteria
Medical conditions * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Hypersensitivity to latex. * History of severe combined immunodeficiency. * History of seizures or progressive neurological disease. * Family history of congenital or hereditary immunodeficiency. * Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception (IS). * History of IS. * Major congenital defects, or serious chronic illness as assessed by the investigator. * Any contraindications to IPV. * Previous confirmed occurrence of rotavirus gastroenteritis (RVGE). * History of poliomyelitis. * Participants with confirmed or suspected Coronavirus Disease 2019 (COVID-19). Prior/Concomitant therapy * Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or planned use during the study period. * Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study interventions administration\*, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations. \*In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. * Administration of long-acting immune-modifying drugs from birth or planned administration at any time during the study period. * Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone \>=0.5 milligram/kilogram (kg)/day, or equivalent. Inhaled, intra-articular and topical steroids are allowed. * Previous vaccination against RV. * Previous vaccination against poliomyelitis. Prior/Concurrent clinical study experience \- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention. Other exclusions \- Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) | At Month 3.5 (1 month post-Dose 3 of IPV) | Seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing Ab is defined as: - Ab titer greater than or equal to (\>=) 1:8 at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer lower than (\<) 1:8 at pre-vaccination, \>= 4-fold increase in Ab titer at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer \>= 1:8 at pre-vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | At Month 3.5 (1 month post-Dose 3 of IPV) | — |
| Percentage of Participants With Seroconversion for Anti-rotavirus (RV) Immunoglobulin A (IgA) Ab | At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group) | Seroconversion for anti-RV IgA Ab is defined as: anti-RV IgA Ab concentration \>= 20 unit per milliliter (U/mL) at 1 month post-Dose 2 of HRV PCV-free vaccine, in participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration \< 20 U/mL prior to the first dose of HRV PCV-free vaccine). |
| Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab | At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group) | — |
| Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab | At Month 3.5 (1 month post-Dose 3 of IPV) | — |
| Number of Participants Reporting Any Solicited Systemic Events | Within 14 days after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group) | Solicited systemic events include cough/runny nose, diarrhoea, fever (pyrexia), irritability/fussiness, loss of appetite and vomiting. Fever is defined as body temperature \>= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. |
| Number of Participants Reporting Any Unsolicited Adverse Events (AEs) | Within 31 days after each dose of HRV PCV-free vaccine (administered at Day 1 and Month 1 for Staggered Group and at Month 0.5 and Month 1.5 for Co-administration group) | Unsolicited AEs include any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination. |
| Number of Participants Reporting Any Serious Adverse Events (SAEs) | From the first dose of the study intervention (Day 1 for Staggered group and Month 0.5 for Co-administration group) up to study end (Month 3.5) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious per medical or scientific judgment. Any = occurrence the event regardless of intensity grade or relation to the study vaccination. |
| Percentage of Participants With Anti-RV IgA Ab Concentrations >= 90 U/mL | At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group) | — |
Countries
China
Participant flow
Recruitment details
This study was conducted in China.
Pre-assignment details
A total of 400 participants were included in Enrolled set, out of which only 392 were included in Exposed set and started the study.
Participants by arm
| Arm | Count |
|---|---|
| Staggered Group Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5. | 199 |
| Co-administration Group Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5. | 193 |
| Total | 392 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Adverse event requiring expedited reporting | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Migrated / Moved from the study area | 4 | 3 |
| Overall Study | Other | 7 | 0 |
Baseline characteristics
| Characteristic | Staggered Group | Co-administration Group | Total |
|---|---|---|---|
| Age, Continuous | 8.1 Weeks STANDARD_DEVIATION 1.2 | 8.2 Weeks STANDARD_DEVIATION 1.3 | 8.1 Weeks STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized ASIAN | 199 Participants | 193 Participants | 392 Participants |
| Sex: Female, Male Female | 96 Participants | 92 Participants | 188 Participants |
| Sex: Female, Male Male | 103 Participants | 101 Participants | 204 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 199 | 0 / 193 |
| other Total, other adverse events | 141 / 199 | 129 / 193 |
| serious Total, serious adverse events | 30 / 199 | 30 / 193 |
Outcome results
Primary
Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab)
Seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing Ab is defined as: - Ab titer greater than or equal to (\>=) 1:8 at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer lower than (\<) 1:8 at pre-vaccination, \>= 4-fold increase in Ab titer at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer \>= 1:8 at pre-vaccination.
Time frame: At Month 3.5 (1 month post-Dose 3 of IPV)
Population: Analysis was performed on the per protocol set (PPS) for IPV, comprising participants who adhered to their assigned intervention schedule without conditions affecting immunogenicity or using prohibited treatments. For anti-poliovirus types 1, 2, and 3 at 1 month post-Dose 3, participants must have pre- and post-vaccination immunogenicity data for at least one antigen and adhered to the interval between Dose 3 and blood sample at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Staggered Group | Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) | anti-poliovirus serotype1 | 99.2 Percentage of participants |
| Staggered Group | Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) | anti-poliovirus serotype2 | 100 Percentage of participants |
| Staggered Group | Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) | anti-poliovirus serotype3 | 100 Percentage of participants |
| Co-administration Group | Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) | anti-poliovirus serotype1 | 99.3 Percentage of participants |
| Co-administration Group | Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) | anti-poliovirus serotype2 | 99.3 Percentage of participants |
| Co-administration Group | Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) | anti-poliovirus serotype3 | 100 Percentage of participants |
Comparison: To demonstrate the immunological non-inferiority of IPV when co-administered with HRV PCV-free compared with IPV administered alone in terms of seroconversion rates 1-month post-Dose 3 of IPV (Month 3.5).95% CI: [-3.14, 3.76]
Comparison: To demonstrate the immunological non-inferiority of IPV when co-administered with HRV PCV-free compared with IPV administered alone in terms of seroconversion rates 1-month post-Dose 3 of IPV (Month 3.5).95% CI: [-3.86, 2.3]
Comparison: To demonstrate the immunological non-inferiority of IPV when co-administered with HRV PCV-free compared with IPV administered alone in terms of seroconversion rates 1-month post-Dose 3 of IPV (Month 3.5).95% CI: [-2.63, 2.99]
Secondary
Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab
Time frame: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Population: Analysis was performed on the PPS for RV. Only participants with data available at the specified timepoints were included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Staggered Group | Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab | 160.59 U/mL |
| Co-administration Group | Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab | 222.15 U/mL |
Secondary
Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab
Time frame: At Month 3.5 (1 month post-Dose 3 of IPV)
Population: Analysis was performed on the PPS for IPV. Only participants with data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Staggered Group | Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab | anti-poliovirus serotype1 | 1369.71 Titers |
| Staggered Group | Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab | anti-poliovirus serotype2 | 194.95 Titers |
| Staggered Group | Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab | anti-poliovirus serotype3 | 451.36 Titers |
| Co-administration Group | Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab | anti-poliovirus serotype2 | 190.44 Titers |
| Co-administration Group | Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab | anti-poliovirus serotype1 | 1374.44 Titers |
| Co-administration Group | Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab | anti-poliovirus serotype3 | 450.15 Titers |
Secondary
Number of Participants Reporting Any Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious per medical or scientific judgment. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Time frame: From the first dose of the study intervention (Day 1 for Staggered group and Month 0.5 for Co-administration group) up to study end (Month 3.5)
Population: Analysis was performed on the Exposed set, which includes all participants who received at least one dose of any of the 2 study interventions and for whom SAE data were available after the corresponding vaccinations for the specified duration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staggered Group | Number of Participants Reporting Any Serious Adverse Events (SAEs) | 30 Participants |
| Co-administration Group | Number of Participants Reporting Any Serious Adverse Events (SAEs) | 30 Participants |
Secondary
Number of Participants Reporting Any Solicited Systemic Events
Solicited systemic events include cough/runny nose, diarrhoea, fever (pyrexia), irritability/fussiness, loss of appetite and vomiting. Fever is defined as body temperature \>= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: Within 14 days after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group)
Population: Analysis was performed on the Exposed set, which includes all participants who received at least one dose of any of the 2 study interventions and for whom solicited systemic events data were available after the corresponding vaccination for the specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Loss of appetite, post vaccination at Day 1 | 14 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Loss of appetite, post vaccination at Month 0.5 | 10 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Diarrhoea, post vaccination at Month 0.5 | 10 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Loss of appetite, post vaccination at Month 1 | 5 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Loss of appetite, post vaccination at Month 1.5 | 5 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Cough/Runny Nose, post vaccination at Day 1 | 21 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Vomiting, post vaccination at Day 1 | 12 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Vomiting, post vaccination at Month 0.5 | 6 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Diarrhoea, post vaccination at Month 1.5 | 7 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Vomiting, post vaccination at Month 1 | 6 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Vomiting, post vaccination at Month 1.5 | 1 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Cough/Runny Nose, post vaccination at Month 0.5 | 28 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Fever, post vaccination at Day 1 | 15 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Fever, post vaccination at Month 0.5 | 46 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Cough/Runny Nose, post vaccination at Month 1 | 27 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Fever, post vaccination at Month 1 | 33 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Fever, post vaccination at Month 1.5 | 25 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Cough/Runny Nose, post vaccination at Month 1.5 | 23 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Irritability/Fussiness, post vaccination at Day 1 | 15 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Irritability/Fussiness, post vaccination at Month 0.5 | 11 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Diarrhoea, post vaccination at Month 1 | 11 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Irritability/Fussiness, post vaccination at Month 1 | 6 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Irritability/Fussiness, post vaccination at Month 1.5 | 6 Participants |
| Staggered Group | Number of Participants Reporting Any Solicited Systemic Events | Diarrhoea, post vaccination at Day 1 | 8 Participants |
| Co-administration Group | Number of Participants Reporting Any Solicited Systemic Events | Vomiting, post vaccination at Month 1.5 | 7 Participants |
| Co-administration Group | Number of Participants Reporting Any Solicited Systemic Events | Cough/Runny Nose, post vaccination at Month 1.5 | 22 Participants |
| Co-administration Group | Number of Participants Reporting Any Solicited Systemic Events | Diarrhoea, post vaccination at Month 0.5 | 9 Participants |
| Co-administration Group | Number of Participants Reporting Any Solicited Systemic Events | Diarrhoea, post vaccination at Month 1.5 | 12 Participants |
| Co-administration Group | Number of Participants Reporting Any Solicited Systemic Events | Fever, post vaccination at Month 0.5 | 23 Participants |
| Co-administration Group | Number of Participants Reporting Any Solicited Systemic Events | Fever, post vaccination at Month 1.5 | 21 Participants |
| Co-administration Group | Number of Participants Reporting Any Solicited Systemic Events | Irritability/Fussiness, post vaccination at Month 0.5 | 19 Participants |
| Co-administration Group | Number of Participants Reporting Any Solicited Systemic Events | Irritability/Fussiness, post vaccination at Month 1.5 | 7 Participants |
| Co-administration Group | Number of Participants Reporting Any Solicited Systemic Events | Loss of appetite, post vaccination at Month 0.5 | 20 Participants |
| Co-administration Group | Number of Participants Reporting Any Solicited Systemic Events | Loss of appetite, post vaccination at Month 1.5 | 4 Participants |
| Co-administration Group | Number of Participants Reporting Any Solicited Systemic Events | Vomiting, post vaccination at Month 0.5 | 18 Participants |
| Co-administration Group | Number of Participants Reporting Any Solicited Systemic Events | Cough/Runny Nose, post vaccination at Month 0.5 | 27 Participants |
Secondary
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
Unsolicited AEs include any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Time frame: Within 31 days after each dose of HRV PCV-free vaccine (administered at Day 1 and Month 1 for Staggered Group and at Month 0.5 and Month 1.5 for Co-administration group)
Population: Analysis was performed on the Exposed set, which includes all participants who received at least one dose of any of the 2 study interventions and for whom unsolicited AEs data were available after the corresponding vaccination for the specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staggered Group | Number of Participants Reporting Any Unsolicited Adverse Events (AEs) | HRV PCV-free: post-Dose 1 | 38 Participants |
| Staggered Group | Number of Participants Reporting Any Unsolicited Adverse Events (AEs) | HRV PCV-free: post-Dose 2 | 39 Participants |
| Co-administration Group | Number of Participants Reporting Any Unsolicited Adverse Events (AEs) | HRV PCV-free: post-Dose 1 | 45 Participants |
| Co-administration Group | Number of Participants Reporting Any Unsolicited Adverse Events (AEs) | HRV PCV-free: post-Dose 2 | 34 Participants |
Secondary
Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64
Time frame: At Month 3.5 (1 month post-Dose 3 of IPV)
Population: Analysis was performed on the PPS for IPV. Only participants with data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Staggered Group | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | anti-poliovirus serotype1, >=1:64 | 100 Percentage of participants |
| Staggered Group | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | anti-poliovirus serotype2, >=1:64 | 91.2 Percentage of participants |
| Staggered Group | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | anti-poliovirus serotype1, >=1:8 | 100 Percentage of participants |
| Staggered Group | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | anti-poliovirus serotype3, >=1:8 | 100 Percentage of participants |
| Staggered Group | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | anti-poliovirus serotype2, >=1:8 | 100 Percentage of participants |
| Staggered Group | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | anti-poliovirus serotype3, >=1:64 | 98.4 Percentage of participants |
| Co-administration Group | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | anti-poliovirus serotype3, >=1:64 | 99.3 Percentage of participants |
| Co-administration Group | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | anti-poliovirus serotype1, >=1:8 | 100 Percentage of participants |
| Co-administration Group | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | anti-poliovirus serotype1, >=1:64 | 100 Percentage of participants |
| Co-administration Group | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | anti-poliovirus serotype2, >=1:8 | 100 Percentage of participants |
| Co-administration Group | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | anti-poliovirus serotype2, >=1:64 | 91.6 Percentage of participants |
| Co-administration Group | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | anti-poliovirus serotype3, >=1:8 | 100 Percentage of participants |
Secondary
Percentage of Participants With Anti-RV IgA Ab Concentrations >= 90 U/mL
Time frame: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Population: Analysis was performed on the PPS for RV. Only participants with data available at the specified timepoints were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Staggered Group | Percentage of Participants With Anti-RV IgA Ab Concentrations >= 90 U/mL | 63.8 Percentage of participants |
| Co-administration Group | Percentage of Participants With Anti-RV IgA Ab Concentrations >= 90 U/mL | 68.5 Percentage of participants |
Secondary
Percentage of Participants With Seroconversion for Anti-rotavirus (RV) Immunoglobulin A (IgA) Ab
Seroconversion for anti-RV IgA Ab is defined as: anti-RV IgA Ab concentration \>= 20 unit per milliliter (U/mL) at 1 month post-Dose 2 of HRV PCV-free vaccine, in participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration \< 20 U/mL prior to the first dose of HRV PCV-free vaccine).
Time frame: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Population: Analysis was performed on the PPS for RV, comprising participants who adhered to their assigned intervention schedule without conditions affecting immunogenicity or using prohibited treatments. For anti-RV IgA analyses at 1 month post Dose 2 of HRV PCV-free, participants should have pre- and post-vaccination immunogenicity results and should have complied with the interval between HRV Dose 2 and the post HRV PCV-free Dose 2 blood sample at the specified timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Staggered Group | Percentage of Participants With Seroconversion for Anti-rotavirus (RV) Immunoglobulin A (IgA) Ab | 78.5 Percentage of participants |
| Co-administration Group | Percentage of Participants With Seroconversion for Anti-rotavirus (RV) Immunoglobulin A (IgA) Ab | 90.4 Percentage of participants |