Trial Outcomes & Findings for A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027) (NCT NCT00836498)
NCT ID: NCT00836498
Last Updated: 2015-05-01
Results Overview
All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card.
TERMINATED
PHASE1
66 participants
Up to 42 days following any dose of RotaTeq™ or placebo
2015-05-01
Participant Flow
Enrollment of participants occurred at 8 study sites in the United States.
Part II was not conducted; no participants were recruited.
Participant milestones
| Measure |
RotaTeq™
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
22
|
|
Overall Study
COMPLETED
|
40
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
RotaTeq™
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027)
Baseline characteristics by cohort
| Measure |
RotaTeq™
n=44 Participants
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
n=22 Participants
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
44 participants
n=5 Participants
|
22 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
22 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 42 days following any dose of RotaTeq™ or placeboPopulation: All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries. Number of participants with one or more adverse experience.
All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card.
Outcome measures
| Measure |
RotaTeq™
n=44 Participants
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
n=22 Participants
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|---|---|---|
|
Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs)
|
26 participants
|
9 participants
|
PRIMARY outcome
Timeframe: Up to 180 days following the third dose of RotaTeq™ or placeboPopulation: All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries. Number of participants with one or more adverse experience.
All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card. SAEs were followed by passive surveillance (in which either participants self reported or information was collected at participants' last visit) for 180 days following the final dose.
Outcome measures
| Measure |
RotaTeq™
n=40 Participants
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
n=21 Participants
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|---|---|---|
|
Part I: Number of Participants With Serious Adverse Experiences (SAEs)
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placeboPopulation: All endpoints exclude protocol violators \& participants with invalid data based on laboratory determinations. Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window \& were not protocol violators.
GMTs of serum anti-rotavirus IgA responses after 1, 2, or 3 doses of RotaTeq™ or placebo.
Outcome measures
| Measure |
RotaTeq™
n=44 Participants
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
n=22 Participants
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|---|---|---|
|
Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)
Pre-Vaccination GMT (n=36 RotaTeq/ n=19 placebo)
|
679.6 titers
Interval 464.5 to 994.2
|
578.4 titers
Interval 361.1 to 926.4
|
|
Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)
Postdose 1 GMT (n=28 RotaTeq/ n=16 placebo)
|
1026.8 titers
Interval 621.6 to 1696.2
|
552.8 titers
Interval 314.5 to 971.8
|
|
Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)
Postdose 2 GMT (n=37 RotaTeq/ n=20 placebo)
|
1187.0 titers
Interval 807.6 to 1744.5
|
657.7 titers
Interval 404.9 to 1068.5
|
|
Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)
Postdose 3 GMT (n=38 RotaTeq/ n=18 placebo)
|
1179.9 titers
Interval 785.5 to 1772.2
|
578.5 titers
Interval 349.0 to 959.0
|
PRIMARY outcome
Timeframe: Up to 42 days following any dose of RotaTeq™ and/or placeboPart II was not conducted due to study termination; this report summarizes study results from Part I only.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 180 days following the third dose of RotaTeq™ and/or placeboPart II was not conducted due to study termination; this report summarizes study results from Part I only.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3Part II was not conducted due to study termination; this report summarizes study results from Part I only.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placeboPopulation: All endpoints exclude protocol violators \& participants with invalid data based on laboratory determinations. Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window \& were not protocol violators.
Outcome measures
| Measure |
RotaTeq™
n=44 Participants
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
n=22 Participants
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|---|---|---|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1
Pre-Vaccination GMT (n=36 RotaTeq/ n=19 Placebo)
|
314.5 titers
Interval 219.2 to 451.3
|
281.4 titers
Interval 152.6 to 519.1
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1
Postdose 1 GMT (n=28 RotaTeq/ n=16 Placebo)
|
506.2 titers
Interval 330.5 to 775.4
|
228.7 titers
Interval 121.0 to 432.4
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1
Postdose 2 GMT (n=37 RotaTeq/ n=20 Placebo)
|
556.1 titers
Interval 389.8 to 793.5
|
226.7 titers
Interval 136.8 to 375.6
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1
Postdose 3 GMT (n=38 RotaTeq/ n=18 Placebo)
|
535.9 titers
Interval 395.9 to 725.4
|
231.6 titers
Interval 140.3 to 382.3
|
SECONDARY outcome
Timeframe: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placeboPopulation: All endpoints exclude protocol violators \& participants with invalid data based on laboratory determinations. Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window \& were not protocol violators.
Outcome measures
| Measure |
RotaTeq™
n=44 Participants
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
n=22 Participants
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|---|---|---|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2
Pre-Vaccination GMT (n= 36 RotaTeq/ n=19 placebo)
|
62.8 titers
Interval 43.6 to 90.5
|
68.2 titers
Interval 40.6 to 114.6
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2
Postdose 1 GMT (n= 28 RotaTeq/ n=16 placebo)
|
123.4 titers
Interval 81.4 to 187.2
|
56.3 titers
Interval 34.5 to 92.0
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2
Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo)
|
111.2 titers
Interval 81.6 to 151.6
|
74.3 titers
Interval 46.2 to 119.5
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2
Postdose 3 GMT (n= 38 RotaTeq/ n=18 placebo)
|
127.0 titers
Interval 93.1 to 173.3
|
71.3 titers
Interval 44.5 to 114.3
|
SECONDARY outcome
Timeframe: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placeboPopulation: All endpoints exclude protocol violators \& participants with invalid data based on laboratory determinations. Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window \& were not protocol violators.
Outcome measures
| Measure |
RotaTeq™
n=44 Participants
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
n=22 Participants
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|---|---|---|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3
Pre-Vaccination GMT (n= 36 RotaTeq/ n=19 placebo)
|
141.8 titers
Interval 95.7 to 210.1
|
90.9 titers
Interval 62.1 to 133.0
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3
Postdose 1 GMT (n= 28 RotaTeq/ n=16 placebo)
|
404.6 titers
Interval 230.6 to 710.0
|
94.5 titers
Interval 59.4 to 150.4
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3
Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo)
|
330.7 titers
Interval 219.5 to 498.3
|
119.8 titers
Interval 79.6 to 180.2
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3
Postdose 3 GMT (n= 38 RotaTeq/ n=18 placebo)
|
388.0 titers
Interval 264.7 to 568.7
|
102.1 titers
Interval 66.3 to 157.3
|
SECONDARY outcome
Timeframe: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placeboPopulation: All endpoints exclude protocol violators \& participants with invalid data based on laboratory determinations. Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window \& were not protocol violators.
Outcome measures
| Measure |
RotaTeq™
n=44 Participants
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
n=22 Participants
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|---|---|---|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4
Pre-Vaccination GMT (n= 36 RotaTeq/ n=19 placebo)
|
91.6 titers
Interval 66.1 to 126.8
|
102.7 titers
Interval 65.7 to 160.4
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4
Postdose 1 GMT (n= 28 RotaTeq/ n=16 placebo)
|
199.2 titers
Interval 128.5 to 308.6
|
93.1 titers
Interval 55.4 to 156.2
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4
Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo)
|
223.9 titers
Interval 154.2 to 325.3
|
110.1 titers
Interval 68.4 to 177.5
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4
Postdose 3 GMT (n= 3 RotaTeq/ n=18 placebo)
|
221.7 titers
Interval 162.9 to 301.7
|
106.9 titers
Interval 64.2 to 178.0
|
SECONDARY outcome
Timeframe: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placeboPopulation: All endpoints exclude protocol violators \& participants with invalid data based on laboratory determinations. Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window \& were not protocol violators.
Outcome measures
| Measure |
RotaTeq™
n=44 Participants
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
n=22 Participants
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|---|---|---|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]
Pre-Vaccination GMT (n= 36 RotaTeq/ n=19 placebo)
|
230.8 titers
Interval 166.8 to 319.4
|
143.4 titers
Interval 88.9 to 231.3
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]
Postdose 1 GMT (n= 28 RotaTeq/ n=16 placebo)
|
306.4 titers
Interval 219.8 to 427.0
|
126.1 titers
Interval 78.7 to 202.0
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]
Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo)
|
375.6 titers
Interval 278.4 to 506.6
|
154.0 titers
Interval 98.0 to 241.9
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]
Postdose 3 GMT (n= 38 RotaTeq/ n=18 placebo)
|
327.6 titers
Interval 253.8 to 423.0
|
160.7 titers
Interval 102.3 to 252.3
|
SECONDARY outcome
Timeframe: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3Part II was not conducted due to study termination; this report summarizes study results from Part I only.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3Part II was not conducted due to study termination; this report summarizes study results from Part I only.
Outcome measures
Outcome data not reported
Adverse Events
RotaTeq™
Placebo
Serious adverse events
| Measure |
RotaTeq™
n=44 participants at risk
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
n=22 participants at risk
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
2.3%
1/44 • Number of events 1
|
0.00%
0/22
|
|
Nervous system disorders
Cerebrovascular accident
|
2.3%
1/44 • Number of events 1
|
0.00%
0/22
|
Other adverse events
| Measure |
RotaTeq™
n=44 participants at risk
Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
Placebo
n=22 participants at risk
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
11/44 • Number of events 16
|
9.1%
2/22 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
11.4%
5/44 • Number of events 5
|
4.5%
1/22 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
3/44 • Number of events 3
|
0.00%
0/22
|
|
General disorders
Fatigue
|
15.9%
7/44 • Number of events 10
|
9.1%
2/22 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.4%
5/44 • Number of events 5
|
4.5%
1/22 • Number of events 3
|
|
Nervous system disorders
Headache
|
15.9%
7/44 • Number of events 14
|
18.2%
4/22 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/44
|
9.1%
2/22 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60