Trial Outcomes & Findings for Phase III Study of Liquid Formulation of ROTAVIN (NCT NCT03703336)

Last Updated: 2021-01-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

825 participants

Primary outcome timeframe

Day 85 (28 days after the second vaccination)

Results posted on

2021-01-25

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	552	273
Overall Study Received Dose 1	552	273
Overall Study Received Dose 2	518	263
Overall Study Safety Population	551	274
Overall Study COMPLETED	514	259
Overall Study NOT COMPLETED	38	14

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Parent withdrew consent	29	8
Overall Study Migration	3	3
Overall Study Protocol Violation	3	1
Overall Study Physician Decision	2	0
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Phase III Study of Liquid Formulation of ROTAVIN

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ROTAVIN Liquid Formulation n=551 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.	ROTAVIN-M1 Frozen Formulation n=274 Participants 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.	Total n=825 Participants Total of all reporting groups
Age, Continuous	74.7 days STANDARD_DEVIATION 8.63 • n=5 Participants	75.2 days STANDARD_DEVIATION 9.15 • n=7 Participants	74.8 days STANDARD_DEVIATION 8.81 • n=5 Participants
Sex: Female, Male Female	276 Participants n=5 Participants	144 Participants n=7 Participants	420 Participants n=5 Participants
Sex: Female, Male Male	275 Participants n=5 Participants	130 Participants n=7 Participants	405 Participants n=5 Participants
Race/Ethnicity, Customized Vietnamese	551 Participants n=5 Participants	274 Participants n=7 Participants	825 Participants n=5 Participants
Province Nam Dinh province	251 Participants n=5 Participants	124 Participants n=7 Participants	375 Participants n=5 Participants
Province Quang Ninh province	300 Participants n=5 Participants	150 Participants n=7 Participants	450 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ROTAVIN Liquid Formulation n=267 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.	ROTAVIN-M1 Frozen Formulation n=135 Participants 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.
Geometric Mean Concentration (GMC) of Serum Anti-rotavirus Immunoglobulin A (IgA) Antibodies 28 Days After Second Vaccination	48.25 U/mL Interval 40.59 to 57.37	35.04 U/mL Interval 27.34 to 44.91

PRIMARY outcome

Timeframe: 7 days after each vaccination (Days 1 to 8 and 57 to 64)

Population: Safety population, as treated

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.

Outcome measures

Outcome measures
Measure	ROTAVIN Liquid Formulation n=551 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.	ROTAVIN-M1 Frozen Formulation n=274 Participants 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.
Number of Participants With Solicited Reactions Within 7 Days of Vaccination Any solicited reaction	195 Participants	102 Participants
Number of Participants With Solicited Reactions Within 7 Days of Vaccination Fever	37 Participants	23 Participants
Number of Participants With Solicited Reactions Within 7 Days of Vaccination Diarrhoea	57 Participants	27 Participants
Number of Participants With Solicited Reactions Within 7 Days of Vaccination Vomiting	78 Participants	33 Participants
Number of Participants With Solicited Reactions Within 7 Days of Vaccination Decreased appetite	68 Participants	28 Participants
Number of Participants With Solicited Reactions Within 7 Days of Vaccination Irritability	92 Participants	48 Participants
Number of Participants With Solicited Reactions Within 7 Days of Vaccination Decreased activity level	35 Participants	23 Participants
Number of Participants With Solicited Reactions Within 7 Days of Vaccination Mild severity	173 Participants	85 Participants
Number of Participants With Solicited Reactions Within 7 Days of Vaccination Moderate severity	61 Participants	37 Participants
Number of Participants With Solicited Reactions Within 7 Days of Vaccination Severe severity	22 Participants	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ROTAVIN Liquid Formulation n=267 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.	ROTAVIN-M1 Frozen Formulation n=135 Participants 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.
Percentage of Participants With Seroconversion 28 Days After the Second Vaccination	70.4 percentage of participants Interval 64.54 to 75.82	64.4 percentage of participants Interval 55.75 to 72.49

SECONDARY outcome

Timeframe: Baseline (Day 1) and at 28 days after the second vaccination (Day 85)

Seropositivity is defined as serum IgA antibody concentration ≥ 20 U/mL

Outcome measures

Outcome measures
Measure	ROTAVIN Liquid Formulation n=267 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.	ROTAVIN-M1 Frozen Formulation n=135 Participants 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.
Percentage of Participants With Seropositivity at Baseline and 28 Days After the Second Vaccination Day 1	0.4 percentage of participants Interval 0.01 to 2.07	0.0 percentage of participants Interval 0.0 to 2.7
Percentage of Participants With Seropositivity at Baseline and 28 Days After the Second Vaccination Day 85	70.8 percentage of participants Interval 64.93 to 76.17	64.4 percentage of participants Interval 55.75 to 72.49

SECONDARY outcome

Timeframe: Within 30 minutes after each vaccination on Day 1 and Day 57

Population: Safety population, as treated

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

Outcome measures

Outcome measures
Measure	ROTAVIN Liquid Formulation n=551 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.	ROTAVIN-M1 Frozen Formulation n=274 Participants 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.
Number of Participants With Immediate Adverse Events (AEs) Any immediate adverse event	2 Participants	0 Participants
Number of Participants With Immediate Adverse Events (AEs) Immediate AEs occurring after dose 1	0 Participants	0 Participants
Number of Participants With Immediate Adverse Events (AEs) Immediate AEs occurring after dose 2	2 Participants	0 Participants
Number of Participants With Immediate Adverse Events (AEs) Vomiting	1 Participants	0 Participants
Number of Participants With Immediate Adverse Events (AEs) Pyrexia	1 Participants	0 Participants
Number of Participants With Immediate Adverse Events (AEs) Mild Immediate AEs	2 Participants	0 Participants
Number of Participants With Immediate Adverse Events (AEs) Moderate Immediate AEs	0 Participants	0 Participants
Number of Participants With Immediate Adverse Events (AEs) Severe Immediate AEs	0 Participants	0 Participants
Number of Participants With Immediate Adverse Events (AEs) Life-threatening Immediate AEs	0 Participants	0 Participants
Number of Participants With Immediate Adverse Events (AEs) Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From vaccination through 28 days after each dose (Days 1 to 28 and 57 to 85)

Population: Safety population, as treated

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.

Outcome measures

Outcome measures
Measure	ROTAVIN Liquid Formulation n=551 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.	ROTAVIN-M1 Frozen Formulation n=274 Participants 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.
Number of Participants With Unsolicited Adverse Events Any unsolicited adverse events	292 Participants	154 Participants
Number of Participants With Unsolicited Adverse Events Mild adverse events	191 Participants	103 Participants
Number of Participants With Unsolicited Adverse Events Moderate adverse events	132 Participants	63 Participants
Number of Participants With Unsolicited Adverse Events Severe adverse events	20 Participants	10 Participants
Number of Participants With Unsolicited Adverse Events Life-threatening adverse events	0 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events Death	0 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events Related to study vaccine	2 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events Unrelated to study vaccine	291 Participants	154 Participants

SECONDARY outcome

Timeframe: From first vaccination through 28 days after the last vaccination; 85 days

Population: Safety population, as treated

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.

Outcome measures

Outcome measures
Measure	ROTAVIN Liquid Formulation n=551 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.	ROTAVIN-M1 Frozen Formulation n=274 Participants 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.
Number of Participants With Serious Adverse Events Including Intussusception Any serious adverse event	23 Participants	14 Participants
Number of Participants With Serious Adverse Events Including Intussusception SAEs related to study vaccine	3 Participants	3 Participants
Number of Participants With Serious Adverse Events Including Intussusception SAEs unrelated to study vaccine	20 Participants	11 Participants
Number of Participants With Serious Adverse Events Including Intussusception Intussusception	0 Participants	0 Participants

Adverse Events

ROTAVIN Liquid Formulation

Serious events: 23 serious events

Other events: 292 other events

Deaths: 0 deaths

ROTAVIN-M1 Frozen Formulation

Serious events: 14 serious events

Other events: 154 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ROTAVIN Liquid Formulation n=551 participants at risk 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 n=274 participants at risk 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.
Infections and infestations Pneumonia	1.5% 8/551 • 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.	1.1% 3/274 • 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.
Infections and infestations Urinary tract infection	0.18% 1/551 • 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.	0.73% 2/274 • 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.
Infections and infestations Bronchiolitis	0.36% 2/551 • 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.	0.00% 0/274 • 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.
Infections and infestations Bronchitis	0.36% 2/551 • 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.	0.00% 0/274 • 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.
Infections and infestations Nasopharyngitis	0.36% 2/551 • 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.	0.00% 0/274 • 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.
Infections and infestations Pertussis	0.18% 1/551 • 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.	0.36% 1/274 • 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.
Infections and infestations Conjunctivitis	0.18% 1/551 • 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.	0.00% 0/274 • 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.
Infections and infestations Otitis media acute	0.00% 0/551 • 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.	0.36% 1/274 • 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.
Gastrointestinal disorders Gastroenteritis	0.54% 3/551 • 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.	1.8% 5/274 • 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.
Gastrointestinal disorders Enteritis	0.18% 1/551 • 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.	0.36% 1/274 • 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.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/551 • 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.	0.36% 1/274 • 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.
Gastrointestinal disorders Diarrhoea	0.18% 1/551 • 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.	0.00% 0/274 • 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.
Gastrointestinal disorders Diarrhoea infectious	0.18% 1/551 • 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.	0.00% 0/274 • 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.
Skin and subcutaneous tissue disorders Rash	0.36% 2/551 • 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.	0.00% 0/274 • 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.

Other adverse events

Additional Information

Nguyen Thuy Huong, Ph.D, Vice Director

POLYVAC

Phone: +84 912514309

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place