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| ID | Type | Description | Link |
|---|---|---|---|
| VX.2018.05 | Other Identifier | Vietnam Ministry of Health |
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| Name | Class |
|---|---|
| PATH | OTHER |
| National Institute of Hygiene and Epidemiology, Vietnam | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROTAVIN Liquid Formulation | Experimental | Participants received two doses of ROTAVIN liquid formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age. |
|
| ROTAVIN-M1 Frozen Formulation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROTAVIN (liquid formulation) | Biological | Live attenuated human rotavirus vaccine containing ≥ 2x10^6 plaque forming units (PFU) of strain G1P[8] per dose of 2 mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 85 (28 days after the second vaccination) |
| 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. | 7 days after each vaccination (Days 1 to 8 and 57 to 64) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days after the second vaccination (Day 85) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niraj Rathi, MD | PATH India | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CDC Nam Dinh | Nam Định | 10000 | Vietnam | |||
| CDC Quang Ninh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34218961 | Derived | Thiem VD, Anh DD, Ha VH, Hien ND, Huong NT, Nga NT, Thang TC, McNeal MM, Meyer N, Pham HL, Huong NM, Gompana G, Cassels F, Tang Y, Flores J, Rathi N. Safety and immunogenicity of two formulations of rotavirus vaccine in Vietnamese infants. Vaccine. 2021 Jul 22;39(32):4463-4470. doi: 10.1016/j.vaccine.2021.06.056. Epub 2021 Jul 1. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population, as treated
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | ROTAVIN-M1 Frozen Formulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | U/mL | Day 85 (28 days after the second vaccination) |
|
Serious adverse events and mortality are reported from the first vaccination date until 28 days after last dose; 85 days. Other adverse events are reported up to 28 days after each dose (Days 1-28 and 57 to 85)
Safety population, as treated One participant was randomized to ROTAVIN but instead received ROTAVIN-M1 and was therefore analyzed in the ROTAVIN-M1 group for safety based on the actual treatment received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nguyen Thuy Huong, Ph.D, Vice Director | POLYVAC | +84 912514309 | huong72us@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 20, 2019 | Dec 15, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2020 | Dec 15, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Eligible infants will be randomized to receive either ROTAVIN or ROTAVIN-M1 vaccines in the ratio of 2:1.
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| ROTAVIN-M1 (frozen formulation) | Biological | Live attenuated human rotavirus vaccine containing ≥ 2x10^6 PFU of strain G1P[8] per dose of 2 mL. |
|
| 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 | Baseline (Day 1) and at 28 days after the second vaccination (Day 85) |
| 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 | Within 30 minutes after each vaccination on Day 1 and Day 57 |
| 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. | From vaccination through 28 days after each dose (Days 1 to 28 and 57 to 85) |
| 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:
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. | From first vaccination through 28 days after the last vaccination; 85 days |
| Quang Ninh |
| 10000 |
| Vietnam |
| Protocol Violation |
|
| Physician Decision |
|
| Adverse Event |
|
| Lost to Follow-up |
|
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.
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Province | Count of Participants | Participants |
|
Participants received two doses of ROTAVIN liquid formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age.
| OG001 | 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. |
|
|
|
| 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. | Safety population, as treated | Posted | Count of Participants | Participants | 7 days after each vaccination (Days 1 to 8 and 57 to 64) |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 28 days after the second vaccination (Day 85) |
|
|
|
|
| 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 | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1) and at 28 days after the second vaccination (Day 85) |
|
|
|
|
| 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 | Safety population, as treated | Posted | Count of Participants | Participants | Within 30 minutes after each vaccination on Day 1 and Day 57 |
|
|
|
| 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. | Safety population, as treated | Posted | Count of Participants | Participants | From vaccination through 28 days after each dose (Days 1 to 28 and 57 to 85) |
|
|
|
| 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:
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. | Safety population, as treated | Posted | Count of Participants | Participants | From first vaccination through 28 days after the last vaccination; 85 days |
|
|
|
| 0 |
| 551 |
| 23 |
| 551 |
| 292 |
| 551 |
| EG001 | 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. | 0 | 274 | 14 | 274 | 154 | 274 |
| Urinary tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Pertussis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Diarrhoea infectious | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Vaccination site inflammation | General disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Lymph node tuberculosis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Pertussis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Pharyngitis bacterial | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Roseola | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Diarrhoea infectious | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastrointestinal infection | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| External ear inflammation | Ear and labyrinth disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Nasal cavity packing | Surgical and medical procedures | MedDRA Version 22.0 | Systematic Assessment |
|
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| Diarrhoea |
|
| Vomiting |
|
| Decreased appetite |
|
| Irritability |
|
| Decreased activity level |
|
| Mild severity |
|
| Moderate severity |
|
| Severe severity |
|
| Percentage Difference |
| 6.3 |
| 2-Sided |
| 95 |
| -3.19 |
| 16.23 |
| Other |
| Immediate AEs occurring after dose 2 |
|
| Vomiting |
|
| Pyrexia |
|
| Mild Immediate AEs |
|
| Moderate Immediate AEs |
|
| Severe Immediate AEs |
|
| Life-threatening Immediate AEs |
|
| Death |
|
| Moderate adverse events |
|
| Severe adverse events |
|
| Life-threatening adverse events |
|
| Death |
|
| Related to study vaccine |
|
| Unrelated to study vaccine |
|
| SAEs unrelated to study vaccine |
|
| Intussusception |
|