Diarrhea, Diarrhea Rotavirus
Conditions
Keywords
ROTAVIN, Rotavirus vaccine, Rotavirus, Diarrhea
Brief summary
This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine (ROTAVIN-M1), 28 days after the second vaccination when administered as two dose series starting at 2-3 months of age. The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination.
Detailed description
The study is designed as a phase III, randomized, partially double-blinded, active controlled study with two groups of infants receiving vaccines at the ratio of 2:1 (liquid formulation of ROTAVIN to frozen formulation ROTAVIN-M1), to compare their immunogenicity and safety. Two doses of vaccine will be administered 8 weeks apart with the first vaccine administration between 60-91 days of age. All childhood vaccines as per the Expanded Program for Immunization of the Government of Vietnam (including Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b and Hepatitis B vaccine (DTwPHib-HepB), and Oral Polio Vaccine at at 2, 3 and 4 months of age) will be allowed as per the immunization schedule. Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period after each vaccination, unsolicited adverse events (AEs) for 4 weeks after each vaccination and serious adverse events (SAEs) including intussusception over the period between first vaccination and four weeks after the last vaccination will be conducted for all infants. This trial will generate immunogenicity and safety data which would be submitted to Ministry of Health in Vietnam for license of new formulation of ROTAVIN vaccine.
Interventions
BIOLOGICALROTAVIN (liquid formulation)
Live attenuated human rotavirus vaccine containing ≥ 2x10\^6 plaque forming units (PFU) of strain G1P\[8\] per dose of 2 mL.
BIOLOGICALROTAVIN-M1 (frozen formulation)
Live attenuated human rotavirus vaccine containing ≥ 2x10\^6 PFU of strain G1P\[8\] per dose of 2 mL.
Sponsors
PATH
National Institute of Hygiene and Epidemiology, Vietnam
Children's Hospital Medical Center, Cincinnati
Center for Research and Production of Vaccines and Biologicals, Vietnam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Eligible infants will be randomized to receive either ROTAVIN or ROTAVIN-M1 vaccines in the ratio of 2:1.
Eligibility
Sex/Gender
ALL
Age
60 Days to 91 Days
Healthy volunteers
Yes
Inclusion criteria
1. Healthy infants as established by medical history and clinical examination before entering the study. 2. Age: 60-91 days (both days inclusive) at the time of enrollment. 3. Parental/legally acceptable representative ability and willingness to provide written informed consent. 4. Parent/legally acceptable representative who intends to remain in the area with the child during the study period.
Exclusion criteria
1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion). 2. Presence of fever on the day of enrollment (temporary exclusion). 3. Acute disease at the time of enrollment (temporary exclusion). 4. Concurrent participation in another clinical trial at any point throughout the entire time frame for this study. 5. Presence of significant malnutrition (weight-for-height z-score \< -3 SD median) 6. Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant's health or is likely to result in nonconformance to the protocol. 7. History of congenital abdominal disorders, intussusception, or abdominal surgery. 8. Known or suspected impairment of immunological function based on medical history and physical examination. 9. Household contact with an immunosuppressed individual or pregnant woman. 10. Prior receipt of rotavirus or an intent to receive this vaccine from outside of the study center during study participation. 11. Prior receipt of Expanded Program on Immunization (EPI) vaccination during past 7 days or plan to receive them within next 7 days. 12. A known sensitivity or allergy to any components of the study vaccine. 13. History of allergy to antibiotic kanamycin. 14. Clinically detectable significant congenital or genetic defect. 15. History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer). 16. Receipt of immunoglobulin therapy and / or blood products since birth or planned administration during the study period. 17. History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study. 18. Any medical condition in the parent/legally acceptable representative or infant which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) of Serum Anti-rotavirus Immunoglobulin A (IgA) Antibodies 28 Days After Second Vaccination | Day 85 (28 days after the second vaccination) | Serum anti-rotavirus IgA antibodies were measured using a validated enzyme linked immunosorbent assay (ELISA) at the Cincinnati Children's Hospital Medical Center (CCHMC), Division of Infectious Diseases in Cincinnati, Ohio USA. |
| Number of Participants With Solicited Reactions Within 7 Days of Vaccination | 7 days after each vaccination (Days 1 to 8 and 57 to 64) | Solicited post-vaccination reactogenicity included fever, diarrhea, vomiting, decreased appetite, irritability, and decreased activity level during the seven-day period after each vaccination. Parents were asked to record reactions on a post-immunization diary card. Solicited reactions were graded for severity on a scale from mild to severe based on the level of symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Immediate Adverse Events (AEs) | Within 30 minutes after each vaccination on Day 1 and Day 57 | After each vaccination participants were observed at the clinic site for at least 30 minutes to check for any immediate AEs including episodes of vomiting and allergic reaction to vaccine. Immediate AEs include all reactions that occurred within 30 minutes of each vaccination. Reactions were graded for severity per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1, of the US National Institute of Health: Grade 1: Mild symptoms causing no or minimal interference with usual social & functional activities; intervention not indicated. Grade 2: Moderate symptoms causing greater than minimal interference with usual activities; intervention indicated. Grade 3: Severe symptoms causing inability to perform usual activities; intervention or hospitalization indicated. Grade 4: Potentially life-threatening symptoms; intervention indicated to prevent permanent impairment, persistent disability, or death Grade 5: Death |
| Percentage of Participants With Seroconversion 28 Days After the Second Vaccination | 28 days after the second vaccination (Day 85) | Seroconversion is defined as a post-vaccination serum anti-rotavirus IgA antibody concentration of at least 20 U/mL if the baseline concentration was \< 20 U/mL or a post- vaccination serum anti-rotavirus IgA antibody concentration of ≥ 4-fold baseline level if the baseline concentration was ≥ 20 U/mL. |
| Number of Participants With Serious Adverse Events Including Intussusception | From first vaccination through 28 days after the last vaccination; 85 days | All Serious adverse events (SAEs), including cases of intussusception, were recorded at all time points between first vaccination and last visit. An SAE was defined as any untoward medical occurrence that: * Resulted in death, * Was life threatening, * Required inpatient hospitalization or prolongation of existing hospitalization, * Resulted in persistent or significant disability / incapacity, * Was a congenital anomaly or a birth defect, * Medically important event Investigator-confirmed cases of intussusception also qualified as an SAE in this study. Intussusception is the infolding (telescoping) of one segment of the intestine within another, usually resulting in a blockage of the intestine. |
| Number of Participants With Unsolicited Adverse Events | From vaccination through 28 days after each dose (Days 1 to 28 and 57 to 85) | An unsolicited AE was any AE that occurred after vaccination, whether or not deemed related to the product, that was not solicited, or, any solicited reaction that started after 7 days post-vaccination. Severity of unsolicited AEs was graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1. Grade 1: Mild symptoms causing no or minimal interference with usual social & functional activities; intervention not indicated Grade 2: Moderate symptoms causing greater than minimal interference with usual activities; intervention indicated Grade 3: Severe symptoms causing inability to perform usual activities; intervention or hospitalization indicated Grade 4: Potentially life-threatening symptoms; intervention indicated to prevent permanent impairment, persistent disability, or death Grade 5: Death The clinician classified the causality of each AE as related if there was reasonable possibility that the product caused the event. |
| Percentage of Participants With Seropositivity at Baseline and 28 Days After the Second Vaccination | Baseline (Day 1) and at 28 days after the second vaccination (Day 85) | Seropositivity is defined as serum IgA antibody concentration ≥ 20 U/mL |
Countries
Vietnam
Participant flow
Recruitment details
This study was conducted by the National Institute of Hygiene and Epidemiology (NIHE) at 12 health centers in one district in the Nam Dinh province and at 12 health centers in one district in the Quang Ninh province in Vietnam.
Pre-assignment details
Infants were allocated to one of the two groups at a ratio of 2:1 to receive either the ROTAVIN liquid formulation or the frozen formulation ROTAVIN-M1.
Participants by arm
| Arm | Count |
|---|---|
| ROTAVIN Liquid Formulation Participants received two doses of ROTAVIN liquid formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age. | 551 |
| ROTAVIN-M1 Frozen Formulation Participants received two doses of ROTAVIN-M1 frozen formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age. | 274 |
| Total | 825 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Migration | 3 | 3 |
| Overall Study | Parent withdrew consent | 29 | 8 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Protocol Violation | 3 | 1 |
Baseline characteristics
| Characteristic | ROTAVIN-M1 Frozen Formulation | Total | ROTAVIN Liquid Formulation |
|---|---|---|---|
| Age, Continuous | 75.2 days STANDARD_DEVIATION 9.15 | 74.8 days STANDARD_DEVIATION 8.81 | 74.7 days STANDARD_DEVIATION 8.63 |
| Province Nam Dinh province | 124 Participants | 375 Participants | 251 Participants |
| Province Quang Ninh province | 150 Participants | 450 Participants | 300 Participants |
| Race/Ethnicity, Customized Vietnamese | 274 Participants | 825 Participants | 551 Participants |
| Sex: Female, Male Female | 144 Participants | 420 Participants | 276 Participants |
| Sex: Female, Male Male | 130 Participants | 405 Participants | 275 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 551 | 0 / 274 |
| other Total, other adverse events | 292 / 551 | 154 / 274 |
| serious Total, serious adverse events | 23 / 551 | 14 / 274 |
Outcome results
Primary
Geometric Mean Concentration (GMC) of Serum Anti-rotavirus Immunoglobulin A (IgA) Antibodies 28 Days After Second Vaccination
Serum anti-rotavirus IgA antibodies were measured using a validated enzyme linked immunosorbent assay (ELISA) at the Cincinnati Children's Hospital Medical Center (CCHMC), Division of Infectious Diseases in Cincinnati, Ohio USA.
Time frame: Day 85 (28 days after the second vaccination)
Population: Immunogenicity assays were conducted on the subset of participants enrolled at Quang Ninh.~The Per-Protocol (PP) population was defined as randomized participants who received a study vaccination, provided at least one evaluable serum sample, and who correctly received study vaccine per randomization with no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccines.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ROTAVIN Liquid Formulation | Geometric Mean Concentration (GMC) of Serum Anti-rotavirus Immunoglobulin A (IgA) Antibodies 28 Days After Second Vaccination | 48.25 U/mL |
| ROTAVIN-M1 Frozen Formulation | Geometric Mean Concentration (GMC) of Serum Anti-rotavirus Immunoglobulin A (IgA) Antibodies 28 Days After Second Vaccination | 35.04 U/mL |
95% CI: [1.02, 1.86]
Primary
Number of Participants With Solicited Reactions Within 7 Days of Vaccination
Solicited post-vaccination reactogenicity included fever, diarrhea, vomiting, decreased appetite, irritability, and decreased activity level during the seven-day period after each vaccination. Parents were asked to record reactions on a post-immunization diary card. Solicited reactions were graded for severity on a scale from mild to severe based on the level of symptoms.
Time frame: 7 days after each vaccination (Days 1 to 8 and 57 to 64)
Population: Safety population, as treated
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ROTAVIN Liquid Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Any solicited reaction | 195 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Fever | 37 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Diarrhoea | 57 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Vomiting | 78 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Decreased appetite | 68 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Irritability | 92 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Decreased activity level | 35 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Mild severity | 173 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Moderate severity | 61 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Severe severity | 22 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Mild severity | 85 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Any solicited reaction | 102 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Irritability | 48 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Fever | 23 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Severe severity | 8 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Diarrhoea | 27 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Decreased activity level | 23 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Vomiting | 33 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Moderate severity | 37 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Solicited Reactions Within 7 Days of Vaccination | Decreased appetite | 28 Participants |
Secondary
Number of Participants With Immediate Adverse Events (AEs)
After each vaccination participants were observed at the clinic site for at least 30 minutes to check for any immediate AEs including episodes of vomiting and allergic reaction to vaccine. Immediate AEs include all reactions that occurred within 30 minutes of each vaccination. Reactions were graded for severity per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1, of the US National Institute of Health: Grade 1: Mild symptoms causing no or minimal interference with usual social & functional activities; intervention not indicated. Grade 2: Moderate symptoms causing greater than minimal interference with usual activities; intervention indicated. Grade 3: Severe symptoms causing inability to perform usual activities; intervention or hospitalization indicated. Grade 4: Potentially life-threatening symptoms; intervention indicated to prevent permanent impairment, persistent disability, or death Grade 5: Death
Time frame: Within 30 minutes after each vaccination on Day 1 and Day 57
Population: Safety population, as treated
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ROTAVIN Liquid Formulation | Number of Participants With Immediate Adverse Events (AEs) | Any immediate adverse event | 2 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Immediate Adverse Events (AEs) | Immediate AEs occurring after dose 1 | 0 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Immediate Adverse Events (AEs) | Immediate AEs occurring after dose 2 | 2 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Immediate Adverse Events (AEs) | Vomiting | 1 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Immediate Adverse Events (AEs) | Pyrexia | 1 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Immediate Adverse Events (AEs) | Mild Immediate AEs | 2 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Immediate Adverse Events (AEs) | Moderate Immediate AEs | 0 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Immediate Adverse Events (AEs) | Severe Immediate AEs | 0 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Immediate Adverse Events (AEs) | Life-threatening Immediate AEs | 0 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Immediate Adverse Events (AEs) | Death | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Immediate Adverse Events (AEs) | Severe Immediate AEs | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Immediate Adverse Events (AEs) | Any immediate adverse event | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Immediate Adverse Events (AEs) | Mild Immediate AEs | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Immediate Adverse Events (AEs) | Immediate AEs occurring after dose 1 | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Immediate Adverse Events (AEs) | Death | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Immediate Adverse Events (AEs) | Immediate AEs occurring after dose 2 | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Immediate Adverse Events (AEs) | Moderate Immediate AEs | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Immediate Adverse Events (AEs) | Vomiting | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Immediate Adverse Events (AEs) | Life-threatening Immediate AEs | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Immediate Adverse Events (AEs) | Pyrexia | 0 Participants |
Secondary
Number of Participants With Serious Adverse Events Including Intussusception
All Serious adverse events (SAEs), including cases of intussusception, were recorded at all time points between first vaccination and last visit. An SAE was defined as any untoward medical occurrence that: * Resulted in death, * Was life threatening, * Required inpatient hospitalization or prolongation of existing hospitalization, * Resulted in persistent or significant disability / incapacity, * Was a congenital anomaly or a birth defect, * Medically important event Investigator-confirmed cases of intussusception also qualified as an SAE in this study. Intussusception is the infolding (telescoping) of one segment of the intestine within another, usually resulting in a blockage of the intestine.
Time frame: From first vaccination through 28 days after the last vaccination; 85 days
Population: Safety population, as treated
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ROTAVIN Liquid Formulation | Number of Participants With Serious Adverse Events Including Intussusception | Any serious adverse event | 23 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Serious Adverse Events Including Intussusception | SAEs related to study vaccine | 3 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Serious Adverse Events Including Intussusception | SAEs unrelated to study vaccine | 20 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Serious Adverse Events Including Intussusception | Intussusception | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Serious Adverse Events Including Intussusception | Intussusception | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Serious Adverse Events Including Intussusception | Any serious adverse event | 14 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Serious Adverse Events Including Intussusception | SAEs unrelated to study vaccine | 11 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Serious Adverse Events Including Intussusception | SAEs related to study vaccine | 3 Participants |
Secondary
Number of Participants With Unsolicited Adverse Events
An unsolicited AE was any AE that occurred after vaccination, whether or not deemed related to the product, that was not solicited, or, any solicited reaction that started after 7 days post-vaccination. Severity of unsolicited AEs was graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1. Grade 1: Mild symptoms causing no or minimal interference with usual social & functional activities; intervention not indicated Grade 2: Moderate symptoms causing greater than minimal interference with usual activities; intervention indicated Grade 3: Severe symptoms causing inability to perform usual activities; intervention or hospitalization indicated Grade 4: Potentially life-threatening symptoms; intervention indicated to prevent permanent impairment, persistent disability, or death Grade 5: Death The clinician classified the causality of each AE as related if there was reasonable possibility that the product caused the event.
Time frame: From vaccination through 28 days after each dose (Days 1 to 28 and 57 to 85)
Population: Safety population, as treated
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ROTAVIN Liquid Formulation | Number of Participants With Unsolicited Adverse Events | Any unsolicited adverse events | 292 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Unsolicited Adverse Events | Mild adverse events | 191 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Unsolicited Adverse Events | Moderate adverse events | 132 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Unsolicited Adverse Events | Severe adverse events | 20 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Unsolicited Adverse Events | Life-threatening adverse events | 0 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Unsolicited Adverse Events | Death | 0 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Unsolicited Adverse Events | Related to study vaccine | 2 Participants |
| ROTAVIN Liquid Formulation | Number of Participants With Unsolicited Adverse Events | Unrelated to study vaccine | 291 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Unsolicited Adverse Events | Unrelated to study vaccine | 154 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Unsolicited Adverse Events | Any unsolicited adverse events | 154 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Unsolicited Adverse Events | Life-threatening adverse events | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Unsolicited Adverse Events | Mild adverse events | 103 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Unsolicited Adverse Events | Related to study vaccine | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Unsolicited Adverse Events | Moderate adverse events | 63 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Unsolicited Adverse Events | Death | 0 Participants |
| ROTAVIN-M1 Frozen Formulation | Number of Participants With Unsolicited Adverse Events | Severe adverse events | 10 Participants |
Secondary
Percentage of Participants With Seroconversion 28 Days After the Second Vaccination
Seroconversion is defined as a post-vaccination serum anti-rotavirus IgA antibody concentration of at least 20 U/mL if the baseline concentration was \< 20 U/mL or a post- vaccination serum anti-rotavirus IgA antibody concentration of ≥ 4-fold baseline level if the baseline concentration was ≥ 20 U/mL.
Time frame: 28 days after the second vaccination (Day 85)
Population: Immunogenicity assays were conducted on the subset of participants enrolled at Quang Ninh.~The Per-Protocol (PP) population was defined as randomized participants who received a study vaccination, provided at least one evaluable serum sample, and who correctly received study vaccine per randomization with no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccines.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ROTAVIN Liquid Formulation | Percentage of Participants With Seroconversion 28 Days After the Second Vaccination | 70.4 percentage of participants |
| ROTAVIN-M1 Frozen Formulation | Percentage of Participants With Seroconversion 28 Days After the Second Vaccination | 64.4 percentage of participants |
95% CI: [-3.57, 15.87]
Secondary
Percentage of Participants With Seropositivity at Baseline and 28 Days After the Second Vaccination
Seropositivity is defined as serum IgA antibody concentration ≥ 20 U/mL
Time frame: Baseline (Day 1) and at 28 days after the second vaccination (Day 85)
Population: Immunogenicity assays were conducted on the subset of participants enrolled at Quang Ninh.~The Per-Protocol (PP) population was defined as randomized participants who received a study vaccination, provided at least one evaluable serum sample, and who correctly received study vaccine per randomization with no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccines.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ROTAVIN Liquid Formulation | Percentage of Participants With Seropositivity at Baseline and 28 Days After the Second Vaccination | Day 1 | 0.4 percentage of participants |
| ROTAVIN Liquid Formulation | Percentage of Participants With Seropositivity at Baseline and 28 Days After the Second Vaccination | Day 85 | 70.8 percentage of participants |
| ROTAVIN-M1 Frozen Formulation | Percentage of Participants With Seropositivity at Baseline and 28 Days After the Second Vaccination | Day 1 | 0.0 percentage of participants |
| ROTAVIN-M1 Frozen Formulation | Percentage of Participants With Seropositivity at Baseline and 28 Days After the Second Vaccination | Day 85 | 64.4 percentage of participants |
Comparison: Percentage Difference on Day 195% CI: [-2.4, 2.09]
Comparison: Percentage Difference on Day 8595% CI: [-3.19, 16.23]