Trial Outcomes & Findings for A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine (NCT NCT03483116)

Results Overview

Cumulative anti rotavirus serum Immunoglobulin A (IgA) response is defined as a ≥3 fold increase from baseline at each serum collection time point to 4 weeks after 3 doses of RV3-BB

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

711 participants

Primary outcome timeframe

At serum collection at approximately 14 weeks of age

Results posted on

2023-07-10

Participant Flow

A two-stage consent process was followed: * Pregnant women were invited to provide preliminary consent during the third trimester and prior to going into labour. * Post birth, the parents/guardians were invited to provide consent for their baby to participate in the study.

Participant milestones

Participant milestones
Measure	High Dose RV3-BB Neonatal Schedule High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Overall Study STARTED	178	179	175	179
Overall Study COMPLETED	150	156	149	148
Overall Study NOT COMPLETED	28	23	26	31

Reasons for withdrawal

Reasons for withdrawal
Measure	High Dose RV3-BB Neonatal Schedule High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Overall Study Adverse Event	0	1	0	1
Overall Study Protocol Violation	1	0	0	7
Overall Study Lost to Follow-up	9	4	9	5
Overall Study Death	1	0	2	1
Overall Study Withdrawal by Subject	14	16	14	16
Overall Study Unknown other reason	3	2	1	1

Baseline Characteristics

Full analysis Set (27 missing)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dose RV3-BB Neonatal Schedule n=178 Participants High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule n=179 Participants Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule n=175 Participants Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule n=179 Participants High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Total n=711 Participants Total of all reporting groups
Age, Categorical <=18 years	178 Participants n=178 Participants	179 Participants n=179 Participants	175 Participants n=175 Participants	179 Participants n=179 Participants	711 Participants n=711 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=178 Participants	0 Participants n=179 Participants	0 Participants n=175 Participants	0 Participants n=179 Participants	0 Participants n=711 Participants
Age, Categorical >=65 years	0 Participants n=178 Participants	0 Participants n=179 Participants	0 Participants n=175 Participants	0 Participants n=179 Participants	0 Participants n=711 Participants
Age, Continuous	1.4 Days STANDARD_DEVIATION 1.5 • n=170 Participants • Full analysis Set (27 missing)	1.4 Days STANDARD_DEVIATION 1.42 • n=173 Participants • Full analysis Set (27 missing)	1.4 Days STANDARD_DEVIATION 1.45 • n=169 Participants • Full analysis Set (27 missing)	1.5 Days STANDARD_DEVIATION 1.39 • n=172 Participants • Full analysis Set (27 missing)	1.5 Days STANDARD_DEVIATION 1.43 • n=684 Participants • Full analysis Set (27 missing)
Sex: Female, Male Female	101 Participants n=178 Participants	84 Participants n=179 Participants	88 Participants n=175 Participants	96 Participants n=179 Participants	369 Participants n=711 Participants
Sex: Female, Male Male	77 Participants n=178 Participants	95 Participants n=179 Participants	87 Participants n=175 Participants	83 Participants n=179 Participants	342 Participants n=711 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=178 Participants	0 Participants n=179 Participants	0 Participants n=175 Participants	0 Participants n=179 Participants	0 Participants n=711 Participants
Race (NIH/OMB) Asian	0 Participants n=178 Participants	0 Participants n=179 Participants	0 Participants n=175 Participants	0 Participants n=179 Participants	0 Participants n=711 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=178 Participants	0 Participants n=179 Participants	0 Participants n=175 Participants	0 Participants n=179 Participants	0 Participants n=711 Participants
Race (NIH/OMB) Black or African American	178 Participants n=178 Participants	179 Participants n=179 Participants	175 Participants n=175 Participants	179 Participants n=179 Participants	711 Participants n=711 Participants
Race (NIH/OMB) White	0 Participants n=178 Participants	0 Participants n=179 Participants	0 Participants n=175 Participants	0 Participants n=179 Participants	0 Participants n=711 Participants
Race (NIH/OMB) More than one race	0 Participants n=178 Participants	0 Participants n=179 Participants	0 Participants n=175 Participants	0 Participants n=179 Participants	0 Participants n=711 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=178 Participants	0 Participants n=179 Participants	0 Participants n=175 Participants	0 Participants n=179 Participants	0 Participants n=711 Participants
Region of Enrollment Malawi	178 Participants n=178 Participants	179 Participants n=179 Participants	175 Participants n=175 Participants	179 Participants n=179 Participants	711 Participants n=711 Participants

PRIMARY outcome

Timeframe: At serum collection at approximately 14 weeks of age

Population: Per protocol population

Cumulative anti rotavirus serum Immunoglobulin A (IgA) response is defined as a ≥3 fold increase from baseline at each serum collection time point to 4 weeks after 3 doses of RV3-BB

Outcome measures

Outcome measures
Measure	High Dose RV3-BB Neonatal Schedule n=141 Participants High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule n=143 Participants Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule n=141 Participants Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Number of Participants With a Cumulative Anti Rotavirus Serum Immunoglobulin A (IgA) Response (≥3 Fold Increase From Baseline) in Neonatal Vaccine Schedule at High Mid and Low Dose of RV3-BB	79 participants	80 participants	57 participants	—

SECONDARY outcome

Timeframe: At serum collection visit approximately 18 weeks of age

Population: Per protocol population

Defined as a ≥3 fold increase from baseline to 4 weeks after 3 doses of RV3-BB at 18 weeks of age

Outcome measures

Outcome measures
Measure	High Dose RV3-BB Neonatal Schedule n=141 Participants High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule n=143 Participants Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule n=141 Participants Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule n=140 Participants High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Number of Participants With a Cumulative Anti Rotavirus Serum IgA Response (≥3 Fold Increase From Baseline) After 3 Doses in an Infant RV3-BB Schedule	100 participants	96 participants	86 participants	82 participants

SECONDARY outcome

Timeframe: At serum collection time points at approximately 14 and 18 weeks of age

Population: Per protocol

Expressed as geometric mean titres (GMTs) from baseline to post dose 3 of RV3-BB Minimum 10 Maximum 250,000 Higher score considered to be immunogenic.

Outcome measures

Outcome measures
Measure	High Dose RV3-BB Neonatal Schedule n=141 Participants High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule n=143 Participants Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule n=141 Participants Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule n=140 Participants High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Serum Anti Rotavirus IgA Titres in Participants Receiving RV3-BB in a Neonatal or Infant Schedule	48.4 geometric mean titres Standard Deviation 22339.87	39.9 geometric mean titres Standard Deviation 21758.64	28.0 geometric mean titres Standard Deviation 7724.19	77.7 geometric mean titres Standard Deviation 25020.69

SECONDARY outcome

Timeframe: Sample collections at Week 0 through to approximately 14 and 18 weeks of age

Population: Per protocol analysis

Vaccine take is defined as at least a threefold increase in serum anti-rotavirus immunoglobulin A (IgA) from baseline to post Investigational product dosing, or detectable RV3 shedding in stools (by ELISA or PCR) any day from day three to day five following administration of Investigational product. Cumulative vaccine take is defined as Vaccine take observed at the current assessment time point or following any previous dose

Outcome measures

Outcome measures
Measure	High Dose RV3-BB Neonatal Schedule n=141 Participants High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule n=140 Participants Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Number of Participants With a Cumulative "Vaccine Take" (Serum Anti Rotavirus IgA Response or Shedding of RV3-BB Vaccine Virus) and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High Dose of RV3-BB. Vaccine take	118 participants	120 participants	—	—
Number of Participants With a Cumulative "Vaccine Take" (Serum Anti Rotavirus IgA Response or Shedding of RV3-BB Vaccine Virus) and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High Dose of RV3-BB. Serum IgA	79 participants	82 participants	—	—
Number of Participants With a Cumulative "Vaccine Take" (Serum Anti Rotavirus IgA Response or Shedding of RV3-BB Vaccine Virus) and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High Dose of RV3-BB. Shedding RV3-BB vaccine virus	85 participants	90 participants	—	—

SECONDARY outcome

Timeframe: Sample collections at Week 0 through to approximately 14 and 18 weeks of age

Population: Per protocol analysis

Vaccine take is defined as at least a threefold increase in serum anti-rotavirus immunoglobulin A (IgA) from baseline to post Investigational Product dosing, or detectable RV3 shedding in stools (by ELISA or PCR) any day from day three to day five following administration of Investigational product. Cumulative vaccine take is defined as Vaccine take observed at the current assessment time point or following any previous dose

Outcome measures

Outcome measures
Measure	High Dose RV3-BB Neonatal Schedule n=143 Participants High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule n=141 Participants Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a Mid or Low Dose of RV3-BB Vaccine take	114 participants	94 participants	—	—
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a Mid or Low Dose of RV3-BB Serum IgA	80 participants	57 participants	—	—
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a Mid or Low Dose of RV3-BB RV3-BB Vaccine Shedding	71 participants	62 participants	—	—

SECONDARY outcome

Timeframe: Sample collections at Week 0 through to approximately 10 and 14 weeks of age

Population: Per protocol population

Vaccine take is defined as at least a threefold increase in serum anti-rotavirus immunoglobulin A (IgA) from baseline to post Investigational product dosing, or detectable RV3 shedding in stools (by ELISA or PCR) any day from day three to day five following administration of Investigational product. Cumulative vaccine take is defined as Vaccine take observed at the current assessment time point or following any previous dose

Outcome measures

Outcome measures
Measure	High Dose RV3-BB Neonatal Schedule n=141 Participants High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule n=143 Participants Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule n=141 Participants Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule n=140 Participants High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 2 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB Vaccine take	98 participants	89 participants	68 participants	98 participants
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 2 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB Serum IgA	56 participants	55 participants	31 participants	58 participants
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 2 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB RV3-BB vaccine shedding	69 participants	52 participants	46 participants	70 participants

SECONDARY outcome

Timeframe: Sample collections at Week 0 through to approximately 6 and 10 weeks of age

Population: Per protocol population

Vaccine take is defined as at least a threefold increase in serum anti-rotavirus immunoglobulin A (IgA) from baseline to post Investigational product dosing, or detectable RV3 shedding in stools (by ELISA or PCR) any day from day three to day five following administration of Investigational product. Cumulative vaccine take is defined as Vaccine take observed at the current assessment time point or following any previous dose

Outcome measures

Outcome measures
Measure	High Dose RV3-BB Neonatal Schedule n=141 Participants High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule n=143 Participants Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule n=141 Participants Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule n=140 Participants High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 1 Dose of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB Vaccine take	51 participants	45 participants	23 participants	64 participants
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 1 Dose of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB Serum IgA	31 participants	31 participants	12 participants	26 participants
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 1 Dose of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB RV3-BB vaccine shedding	29 participants	15 participants	12 participants	48 participants

SECONDARY outcome

Timeframe: First dose of investigational product to Study End at approximately 18 weeks of age

Population: Safety Analysis Set

Number of Participants with Adverse Events

Outcome measures

Outcome measures
Measure	High Dose RV3-BB Neonatal Schedule n=170 Participants High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule n=172 Participants Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule n=169 Participants Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule n=173 Participants High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Occurrence of Adverse Events (AE)	67 participants	68 participants	69 participants	60 participants

SECONDARY outcome

Timeframe: First dose of investigational product to Study End at approximately 18 weeks of age

Population: Safety analysis set

Number of participants with Serious Adverse Events (SAEs)

Outcome measures

Outcome measures
Measure	High Dose RV3-BB Neonatal Schedule n=170 Participants High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule n=172 Participants Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule n=169 Participants Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule n=173 Participants High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Occurrence of Serious Adverse Events (SAEs)	11 participants	7 participants	8 participants	5 participants

SECONDARY outcome

Timeframe: First dose of Investigational product to Study End at approximately 18 weeks of age

Population: Full analysis Set

Diarrhea will be described according to severity and detection of wild type rotavirus in diarrhea samples collected. Severity defined using a modified version of the Vesikari clinical score for gastroenteritis. Severed is modified Vesikari score of greater than or equal to 11. The Vesikari scale is a 20-point scale based on duration and peak frequency of diarrhea and vomiting, degree of temperature, severity of dehydration, and treatment provided to the patient (i.e., rehydration or hospitalization). This scale is divided into three ranges: mild \<7, moderate 7-10, and severe ≥11

Outcome measures

Outcome measures
Measure	High Dose RV3-BB Neonatal Schedule n=178 Participants High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule n=179 Participants Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule n=175 Participants Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule n=179 Participants High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Occurrence of Diarrhea. Severe	1 participants	2 participants	2 participants	0 participants

Adverse Events

High Dose RV3-BB Neonatal Schedule

Serious events: 11 serious events

Other events: 67 other events

Deaths: 1 deaths

Mid Dose RV3-BB Neonatal Schedule

Serious events: 7 serious events

Other events: 68 other events

Deaths: 0 deaths

Low Dose RV3-BB Neonatal Schedule

Serious events: 8 serious events

Other events: 69 other events

Deaths: 2 deaths

High Dose RV3-BB Infant Schedule

Serious events: 5 serious events

Other events: 59 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	High Dose RV3-BB Neonatal Schedule n=170 participants at risk High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Mid Dose RV3-BB Neonatal Schedule n=172 participants at risk Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	Low Dose RV3-BB Neonatal Schedule n=169 participants at risk Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration	High Dose RV3-BB Infant Schedule n=173 participants at risk High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14) RV3-BB: Oral administration Placebo: Oral administration
Infections and infestations Bronchiolitis	1.8% 3/170 • Number of events 3 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	1.7% 3/172 • Number of events 3 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	1.2% 2/169 • Number of events 2 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.58% 1/173 • Number of events 2 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Infections and infestations Gastroenteritis	0.59% 1/170 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/172 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.59% 1/169 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/173 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Infections and infestations Pneumonia	0.59% 1/170 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/172 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.59% 1/169 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/173 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Infections and infestations Sepsis	0.59% 1/170 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/172 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	1.2% 2/169 • Number of events 2 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/173 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Infections and infestations Sepsis Neonatal	1.8% 3/170 • Number of events 3 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.58% 1/172 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.59% 1/169 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.58% 1/173 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Infections and infestations Breast Abscess	0.00% 0/170 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.58% 1/172 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/169 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/173 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Infections and infestations Septic Shock	0.00% 0/170 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/172 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/169 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.58% 1/173 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Infections and infestations Omphalitis	0.00% 0/170 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/172 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/169 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.58% 1/173 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Gastrointestinal disorders Constipation	0.00% 0/170 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.58% 1/172 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/169 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/173 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Gastrointestinal disorders Infantile Vomiting	0.00% 0/170 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/172 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/169 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.58% 1/173 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/170 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/172 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.59% 1/169 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/173 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Nervous system disorders Seizure	0.00% 0/170 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.58% 1/172 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/169 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/173 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Pregnancy, puerperium and perinatal conditions Jaundice Neonatal	1.2% 2/170 • Number of events 2 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/172 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/169 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/173 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.59% 1/170 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/172 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.59% 1/169 • Number of events 1 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.	0.00% 0/173 • 18 weeks Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.

Other adverse events

Additional Information

Professor Julie Bines

Murdoch Children's Research Institute

Phone: +61 3 9345 5522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Principal Investigator must not Publish or present any aspect of the Study without the prior written approval of the Sponsor such approval will not to be unreasonably withheld
Publication restrictions are in place

Restriction type: OTHER