Trial Outcomes & Findings for Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants (NCT NCT02109484)
NCT ID: NCT02109484
Last Updated: 2017-12-13
Results Overview
Maximum severity of all local reactions or systemic reactogenicity after any vaccination
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
204 participants
Primary outcome timeframe
7 days following each dose
Results posted on
2017-12-13
Participant Flow
Age de-escalation, dose-escalation study enrolling healthy toddlers and infants between 17 March and 29 September 2014 at a single site in South Africa.
Participant milestones
| Measure |
Cohort A Placebo
Healthy toddlers aged 2 to \<3 months receiving placebo
|
Cohort A 10 mcg P2-VP8
Healthy toddlers 2 to \<3 yrs of age receiving low dose P2-VP8
|
Cohort A 30 mcg P2-VP8
Healthy toddlers aged 2 to \<3 yrs receiving an intermediate dose of P2-VP8
|
Cohort A 60 mcg P2-VP8
Healthy toddlers aged 2 to \< 3 yrs receiving high dose P2-PV8
|
Cohort B Placebo
Healthy Infants aged 6 to \<8 weeks receiving placebo
|
Cohort B 10 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks receiving low dose P2-VP8
|
Cohort B 30 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks of age receiving a medium dose of P2-VP8
|
Cohort B 60 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks receiving high dose of P2-VP8
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
13
|
12
|
12
|
50
|
12
|
50
|
50
|
|
Overall Study
COMPLETED
|
5
|
13
|
12
|
11
|
46
|
11
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
4
|
1
|
3
|
3
|
Reasons for withdrawal
| Measure |
Cohort A Placebo
Healthy toddlers aged 2 to \<3 months receiving placebo
|
Cohort A 10 mcg P2-VP8
Healthy toddlers 2 to \<3 yrs of age receiving low dose P2-VP8
|
Cohort A 30 mcg P2-VP8
Healthy toddlers aged 2 to \<3 yrs receiving an intermediate dose of P2-VP8
|
Cohort A 60 mcg P2-VP8
Healthy toddlers aged 2 to \< 3 yrs receiving high dose P2-PV8
|
Cohort B Placebo
Healthy Infants aged 6 to \<8 weeks receiving placebo
|
Cohort B 10 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks receiving low dose P2-VP8
|
Cohort B 30 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks of age receiving a medium dose of P2-VP8
|
Cohort B 60 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks receiving high dose of P2-VP8
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Moved away from study area
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants
Baseline characteristics by cohort
| Measure |
Cohort A Placebo
n=5 Participants
Healthy toddlers aged 2 to \< 3 years receiving placebo
|
Cohort A 10 mcg P2-VP8
n=13 Participants
Healthy toddlers aged 2 to \< 3 years receiving low dose P2-VP8
|
Cohort A 30 mcg P2-VP8
n=12 Participants
Healthy toddlers aged 2 to \< 3 years receiving Medium Dose Ps-VP9
|
Cohort A 60 mcg P2-VP8
n=12 Participants
Healthy toddlers aged 2 to \< 3 years receiving High Dose P2-VP8
|
Cohort B Placebo
n=50 Participants
Healthy Infants aged 6 to \<8 weeks receiving placeblo
|
Cohort B 10 mcg P2-VP8
n=12 Participants
Healthy Infants aged 6 to \<8 weeks receiving Low Dose P2-VP8
|
Cohort B 30 mcg P2-VP8
n=50 Participants
Healthy Infants aged 6 to \<8 weeks receiving Medium Dose P2-VP8
|
Cohort B 60 mcg P2-VP8
n=50 Participants
Healthy Infants aged 6 to \<8 weeks receiving High Dose P2-VP8
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
25 Participants
n=40 Participants
|
105 Participants
n=8 Participants
|
|
Age, Continuous
|
136.4 weeks
n=93 Participants
|
135.6 weeks
n=4 Participants
|
139.0 weeks
n=27 Participants
|
144.7 weeks
n=483 Participants
|
6.6 weeks
n=36 Participants
|
6.6 weeks
n=10 Participants
|
6.6 weeks
n=115 Participants
|
6.7 weeks
n=40 Participants
|
72.8 weeks
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
25 Participants
n=40 Participants
|
99 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
50 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
49 Participants
n=115 Participants
|
50 Participants
n=40 Participants
|
202 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
South Africa
|
5 participants
n=93 Participants
|
13 participants
n=4 Participants
|
12 participants
n=27 Participants
|
12 participants
n=483 Participants
|
50 participants
n=36 Participants
|
12 participants
n=10 Participants
|
50 participants
n=115 Participants
|
50 participants
n=40 Participants
|
204 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 7 days following each doseMaximum severity of all local reactions or systemic reactogenicity after any vaccination
Outcome measures
| Measure |
Cohort A Placebo
n=5 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo
|
Cohort A 10 mcg P2-VP8
n=13 Participants
Healthy toddlers aged 2 to \<3 months receiving low dose P2-VP8
|
Cohort A 30 mcg P2-VP8
n=12 Participants
Healthy toddlers aged 2 to \<3 months receiving Medium Dose P2-VP8
|
Cohort A 60 mcg P2-VP8
n=12 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo High Dose P2-VP8
|
Cohort B Placebo
n=50 Participants
Healthy Infants aged 6 to \<8 weeks receiving placebo
|
Cohort B 10 mcg P2-VP8
n=12 Participants
Healthy infants aged 6 to \< 8 weeks receiving Low Dose P2-VP8
|
Cohort B 30 mcg P2-VP8
n=50 Participants
Healthy Infants aged 6 to \<8 weeks receiving Medium Dose P2-VP8
|
Cohort B 60 mcg P2-VP8
n=50 Participants
Healthy Infants aged 6 to \<8 weeks receiving High Dose P2-VP8
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vaccine Induced Reactions
None
|
3 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Vaccine Induced Reactions
Mild
|
1 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
29 Participants
|
10 Participants
|
35 Participants
|
37 Participants
|
|
Number of Participants With Vaccine Induced Reactions
Moderate
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
14 Participants
|
0 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants With Vaccine Induced Reactions
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vaccine Induced Reactions
Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: within 28 days of a study dose and at any timePopulation: All subjects that received at least one dose of P2-VP8 vaccine or placebo
Number of participants experiencing a Serious Adverse Event within 28 days of a vaccination and at any time during the study
Outcome measures
| Measure |
Cohort A Placebo
n=5 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo
|
Cohort A 10 mcg P2-VP8
n=13 Participants
Healthy toddlers aged 2 to \<3 months receiving low dose P2-VP8
|
Cohort A 30 mcg P2-VP8
n=12 Participants
Healthy toddlers aged 2 to \<3 months receiving Medium Dose P2-VP8
|
Cohort A 60 mcg P2-VP8
n=12 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo High Dose P2-VP8
|
Cohort B Placebo
n=50 Participants
Healthy Infants aged 6 to \<8 weeks receiving placebo
|
Cohort B 10 mcg P2-VP8
n=12 Participants
Healthy infants aged 6 to \< 8 weeks receiving Low Dose P2-VP8
|
Cohort B 30 mcg P2-VP8
n=50 Participants
Healthy Infants aged 6 to \<8 weeks receiving Medium Dose P2-VP8
|
Cohort B 60 mcg P2-VP8
n=50 Participants
Healthy Infants aged 6 to \<8 weeks receiving High Dose P2-VP8
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events
SAE within 28 days of vaccine receipt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Serious Adverse Events
SAE at any time during follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 6 mo following first vaccinationall adverse events will be recorded over the duration of the 6 month follow up period.
Outcome measures
| Measure |
Cohort A Placebo
n=5 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo
|
Cohort A 10 mcg P2-VP8
n=13 Participants
Healthy toddlers aged 2 to \<3 months receiving low dose P2-VP8
|
Cohort A 30 mcg P2-VP8
n=12 Participants
Healthy toddlers aged 2 to \<3 months receiving Medium Dose P2-VP8
|
Cohort A 60 mcg P2-VP8
n=12 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo High Dose P2-VP8
|
Cohort B Placebo
n=50 Participants
Healthy Infants aged 6 to \<8 weeks receiving placebo
|
Cohort B 10 mcg P2-VP8
n=12 Participants
Healthy infants aged 6 to \< 8 weeks receiving Low Dose P2-VP8
|
Cohort B 30 mcg P2-VP8
n=50 Participants
Healthy Infants aged 6 to \<8 weeks receiving Medium Dose P2-VP8
|
Cohort B 60 mcg P2-VP8
n=50 Participants
Healthy Infants aged 6 to \<8 weeks receiving High Dose P2-VP8
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Any Non-Serious Adverse Event
|
2 Participants
|
7 Participants
|
6 Participants
|
8 Participants
|
41 Participants
|
11 Participants
|
46 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: Baseline to day 84Population: Enrolled infants who received 3 vaccinations and with pre and post-vaccination immunologic parameters measured
Seroresponse is defined as 4 fold rise in Geometric Mean Titer (GMT) between pre-(baseline) and post vaccination (4 weeks after third vaccination). Confidence intervals are displayed as percentages.
Outcome measures
| Measure |
Cohort A Placebo
n=45 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo
|
Cohort A 10 mcg P2-VP8
n=12 Participants
Healthy toddlers aged 2 to \<3 months receiving low dose P2-VP8
|
Cohort A 30 mcg P2-VP8
n=47 Participants
Healthy toddlers aged 2 to \<3 months receiving Medium Dose P2-VP8
|
Cohort A 60 mcg P2-VP8
n=47 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo High Dose P2-VP8
|
Cohort B Placebo
Healthy Infants aged 6 to \<8 weeks receiving placebo
|
Cohort B 10 mcg P2-VP8
Healthy infants aged 6 to \< 8 weeks receiving Low Dose P2-VP8
|
Cohort B 30 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks receiving Medium Dose P2-VP8
|
Cohort B 60 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks receiving High Dose P2-VP8
|
|---|---|---|---|---|---|---|---|---|
|
Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse.
|
9 Participants
|
7 Participants
|
38 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to day 84Seroresponse is defined as 4 fold rise in Geometric Mean Titer (GMT) between pre-(baseline) and post vaccination (4 weeks after third injection).An unadjusted serioresponse was defined as an increase of 4 times or more in titers between baseline and 4 weeks after the 3rd injection. Adjusted IgG and neutralizing antibody post injection titres accounted for the decay in maternal antibodies using the half-life calculated from participants in the placebo group with detectable baseline titers higher than those at the post injection visit.
Outcome measures
| Measure |
Cohort A Placebo
n=45 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo
|
Cohort A 10 mcg P2-VP8
n=12 Participants
Healthy toddlers aged 2 to \<3 months receiving low dose P2-VP8
|
Cohort A 30 mcg P2-VP8
n=47 Participants
Healthy toddlers aged 2 to \<3 months receiving Medium Dose P2-VP8
|
Cohort A 60 mcg P2-VP8
n=47 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo High Dose P2-VP8
|
Cohort B Placebo
Healthy Infants aged 6 to \<8 weeks receiving placebo
|
Cohort B 10 mcg P2-VP8
Healthy infants aged 6 to \< 8 weeks receiving Low Dose P2-VP8
|
Cohort B 30 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks receiving Medium Dose P2-VP8
|
Cohort B 60 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks receiving High Dose P2-VP8
|
|---|---|---|---|---|---|---|---|---|
|
Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses
Unadjusted Seroresponse
|
1 Participants
|
12 Participants
|
46 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses
Adjusted Seroresponse
|
4 Participants
|
12 Participants
|
46 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to Day 84Population: Enrolled infants who received placebo, 10 mcg, 30 mcg or 60 mcg V2-VP8.
Seroresponse is defined as 4 fold rise in Geometric Mean Titer (GMT) between pre-(baseline) and post vaccination (4 weeks after third injection).An unadjusted serioresponse was defined as an increase of 4 times or more in titers between baseline and 4 weeks after the 3rd injection. Adjusted IgG and neutralizing antibody post injection titres accounted for the decay in maternal antibodies using the half-life calculated from participants in the placebo group with detectable baseline titers higher than those at the post injection visit.
Outcome measures
| Measure |
Cohort A Placebo
n=45 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo
|
Cohort A 10 mcg P2-VP8
n=12 Participants
Healthy toddlers aged 2 to \<3 months receiving low dose P2-VP8
|
Cohort A 30 mcg P2-VP8
n=47 Participants
Healthy toddlers aged 2 to \<3 months receiving Medium Dose P2-VP8
|
Cohort A 60 mcg P2-VP8
n=47 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo High Dose P2-VP8
|
Cohort B Placebo
Healthy Infants aged 6 to \<8 weeks receiving placebo
|
Cohort B 10 mcg P2-VP8
Healthy infants aged 6 to \< 8 weeks receiving Low Dose P2-VP8
|
Cohort B 30 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks receiving Medium Dose P2-VP8
|
Cohort B 60 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks receiving High Dose P2-VP8
|
|---|---|---|---|---|---|---|---|---|
|
Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8])
Unadjusted seroresponse to neutralizing antibodies
|
0 Participants
|
7 Participants
|
17 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8])
Adjusted seroresponse to neutralizing antibodies
|
3 Participants
|
12 Participants
|
40 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Rotarix vaccination on Day 84 to day 91Percent of infants who shed rotavirus at any timepoint after receiving 3 doses of study vaccine and one dose of Rotarix. Infants received Rotarix vaccination beginning on Day 84. Stool specimens were collected from these infants on the 5th, 7th and 9th day following first administration of Rotarix. This test was performed as a novel functional assessment of the ability to suppress local gut multiplication of the vaccine strain contained in Rotarix.
Outcome measures
| Measure |
Cohort A Placebo
n=44 Participants
Healthy toddlers aged 2 to \<3 months receiving placebo
|
Cohort A 10 mcg P2-VP8
n=45 Participants
Healthy toddlers aged 2 to \<3 months receiving low dose P2-VP8
|
Cohort A 30 mcg P2-VP8
n=46 Participants
Healthy toddlers aged 2 to \<3 months receiving Medium Dose P2-VP8
|
Cohort A 60 mcg P2-VP8
Healthy toddlers aged 2 to \<3 months receiving placebo High Dose P2-VP8
|
Cohort B Placebo
Healthy Infants aged 6 to \<8 weeks receiving placebo
|
Cohort B 10 mcg P2-VP8
Healthy infants aged 6 to \< 8 weeks receiving Low Dose P2-VP8
|
Cohort B 30 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks receiving Medium Dose P2-VP8
|
Cohort B 60 mcg P2-VP8
Healthy Infants aged 6 to \<8 weeks receiving High Dose P2-VP8
|
|---|---|---|---|---|---|---|---|---|
|
Rotavirus Shedding After Administration of Rotarix in Infants Receiving 3 Doses of Vaccine or Placebo.
Any Timepoint - Rotavirus shedding
|
17 Participants
|
6 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Rotavirus Shedding After Administration of Rotarix in Infants Receiving 3 Doses of Vaccine or Placebo.
No shedding of rotavirus
|
27 Participants
|
39 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort A Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort A 10 mcg P2-VP8
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort A 30 mcg P2-VP8
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort A 60 mcg P2-VP8
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort B Placebo
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
Cohort B 10 mcg P2-VP8
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort B 30 mcg P2-VP8
Serious events: 7 serious events
Other events: 46 other events
Deaths: 0 deaths
Cohort B 60 mcg P2-VP8
Serious events: 8 serious events
Other events: 42 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort A Placebo
n=5 participants at risk
Healthy toddlers aged 2 to \<3 years receiving Placebo
|
Cohort A 10 mcg P2-VP8
n=13 participants at risk
Healthy toddlers aged 2 to \<3 years receiving Low Dose P2-VP8
|
Cohort A 30 mcg P2-VP8
n=12 participants at risk
Healthy toddlers aged 2 to \<3 years receiving Medium Dose P2-VP8
|
Cohort A 60 mcg P2-VP8
n=12 participants at risk
Healthy toddlers aged 2 to \<3 years receiving High Dose P2-VP8
|
Cohort B Placebo
n=50 participants at risk
Healthy Infants aged 6 to \<8 weeks receiving placebo
|
Cohort B 10 mcg P2-VP8
n=12 participants at risk
Healthy Infants aged 6 to \<8 weeks receiving Low Dose P2-VP8
|
Cohort B 30 mcg P2-VP8
n=50 participants at risk
Healthy Infants aged 6 to \<8 weeks receiving Medium Dose P2-VP8
|
Cohort B 60 mcg P2-VP8
n=50 participants at risk
Healthy Infants aged 6 to \<8 weeks receiving High Dose P2-VP8
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
4.0%
2/50 • Number of events 2 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
|
Infections and infestations
Acute gastroenteritis
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
6.0%
3/50 • Number of events 3 • 28 days after any vaccination
|
4.0%
2/50 • Number of events 3 • 28 days after any vaccination
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
|
Infections and infestations
Staphylococcal impetigo
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
|
Infections and infestations
Infected cyst
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
|
General disorders
death
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
4.0%
2/50 • Number of events 2 • 28 days after any vaccination
|
Other adverse events
| Measure |
Cohort A Placebo
n=5 participants at risk
Healthy toddlers aged 2 to \<3 years receiving Placebo
|
Cohort A 10 mcg P2-VP8
n=13 participants at risk
Healthy toddlers aged 2 to \<3 years receiving Low Dose P2-VP8
|
Cohort A 30 mcg P2-VP8
n=12 participants at risk
Healthy toddlers aged 2 to \<3 years receiving Medium Dose P2-VP8
|
Cohort A 60 mcg P2-VP8
n=12 participants at risk
Healthy toddlers aged 2 to \<3 years receiving High Dose P2-VP8
|
Cohort B Placebo
n=50 participants at risk
Healthy Infants aged 6 to \<8 weeks receiving placebo
|
Cohort B 10 mcg P2-VP8
n=12 participants at risk
Healthy Infants aged 6 to \<8 weeks receiving Low Dose P2-VP8
|
Cohort B 30 mcg P2-VP8
n=50 participants at risk
Healthy Infants aged 6 to \<8 weeks receiving Medium Dose P2-VP8
|
Cohort B 60 mcg P2-VP8
n=50 participants at risk
Healthy Infants aged 6 to \<8 weeks receiving High Dose P2-VP8
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
4.0%
2/50 • Number of events 2 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
4.0%
2/50 • Number of events 2 • 28 days after any vaccination
|
4.0%
2/50 • Number of events 2 • 28 days after any vaccination
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
8.0%
4/50 • Number of events 4 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
12.0%
6/50 • Number of events 6 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
4.0%
2/50 • Number of events 2 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
|
General disorders
Pyrexia
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
|
Infections and infestations
Body tinea
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
8.0%
4/50 • Number of events 5 • 28 days after any vaccination
|
16.7%
2/12 • Number of events 2 • 28 days after any vaccination
|
16.0%
8/50 • Number of events 8 • 28 days after any vaccination
|
12.0%
6/50 • Number of events 8 • 28 days after any vaccination
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
6.0%
3/50 • Number of events 3 • 28 days after any vaccination
|
|
Infections and infestations
Conjuntivitis
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 2 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
10.0%
5/50 • Number of events 5 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
10.0%
5/50 • Number of events 5 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
8.0%
4/50 • Number of events 4 • 28 days after any vaccination
|
6.0%
3/50 • Number of events 3 • 28 days after any vaccination
|
|
Infections and infestations
Helminthic infection
|
0.00%
0/5 • 28 days after any vaccination
|
7.7%
1/13 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
|
Infections and infestations
Impetigo
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
16.7%
2/12 • Number of events 2 • 28 days after any vaccination
|
4.0%
2/50 • Number of events 2 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/5 • 28 days after any vaccination
|
7.7%
1/13 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
16.7%
2/12 • Number of events 2 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • 28 days after any vaccination
|
23.1%
3/13 • Number of events 3 • 28 days after any vaccination
|
41.7%
5/12 • Number of events 5 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
48.0%
24/50 • Number of events 31 • 28 days after any vaccination
|
41.7%
5/12 • Number of events 6 • 28 days after any vaccination
|
50.0%
25/50 • Number of events 31 • 28 days after any vaccination
|
60.0%
30/50 • Number of events 40 • 28 days after any vaccination
|
|
Infections and infestations
Varicella
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
|
Infections and infestations
Viral Rash
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.00%
0/5 • 28 days after any vaccination
|
7.7%
1/13 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • 28 days after any vaccination
|
7.7%
1/13 • Number of events 2 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
41.7%
5/12 • Number of events 5 • 28 days after any vaccination
|
6.0%
3/50 • Number of events 4 • 28 days after any vaccination
|
25.0%
3/12 • Number of events 3 • 28 days after any vaccination
|
12.0%
6/50 • Number of events 6 • 28 days after any vaccination
|
8.0%
4/50 • Number of events 4 • 28 days after any vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • 28 days after any vaccination
|
15.4%
2/13 • Number of events 2 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
30.0%
15/50 • Number of events 16 • 28 days after any vaccination
|
16.7%
2/12 • Number of events 2 • 28 days after any vaccination
|
28.0%
14/50 • Number of events 15 • 28 days after any vaccination
|
14.0%
7/50 • Number of events 8 • 28 days after any vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
16.7%
2/12 • Number of events 2 • 28 days after any vaccination
|
6.0%
3/50 • Number of events 3 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
|
Skin and subcutaneous tissue disorders
Dermatitiis
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
6.0%
3/50 • Number of events 4 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
10.0%
5/50 • Number of events 5 • 28 days after any vaccination
|
4.0%
2/50 • Number of events 2 • 28 days after any vaccination
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
14.0%
7/50 • Number of events 8 • 28 days after any vaccination
|
16.7%
2/12 • Number of events 2 • 28 days after any vaccination
|
4.0%
2/50 • Number of events 2 • 28 days after any vaccination
|
2.0%
1/50 • Number of events 1 • 28 days after any vaccination
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/5 • 28 days after any vaccination
|
0.00%
0/13 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/12 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
8.3%
1/12 • Number of events 1 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
0.00%
0/50 • 28 days after any vaccination
|
Additional Information
Michelle J. Groome, MD, PhD
Chris Hani Baragwanath Academic Hospital
Phone: +27 11 983 4283
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place