Trial Outcomes & Findings for An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq) (NCT NCT01960725)
NCT ID: NCT01960725
Last Updated: 2017-04-21
Results Overview
Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
66 participants
Primary outcome timeframe
1 month following vaccine series completion
Results posted on
2017-04-21
Participant Flow
Participant milestones
| Measure |
Group A: Standard Dosing
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
Received First Vaccine
|
33
|
33
|
|
Overall Study
Recieved Second Vaccine
|
33
|
33
|
|
Overall Study
Received Third Vaccine
|
32
|
32
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Group A: Standard Dosing
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
unable to obtain blood sample
|
1
|
2
|
Baseline Characteristics
An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
Baseline characteristics by cohort
| Measure |
Group A: Standard Dosing
n=33 Participants
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
n=33 Participants
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 days
STANDARD_DEVIATION 4.6 • n=99 Participants
|
26.6 days
STANDARD_DEVIATION 7.3 • n=107 Participants
|
44.8 days
STANDARD_DEVIATION 19.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
24 participants
n=99 Participants
|
27 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
9 participants
n=99 Participants
|
4 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 month following vaccine series completionPopulation: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.
Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)
Outcome measures
| Measure |
Group A: Standard Dosing
n=27 Participants
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
n=28 Participants
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
G1 Serum-neutralizing Antibody
|
188 titers
Interval 117.9 to 299.7
|
184.5 titers
Interval 117.0 to 290.8
|
SECONDARY outcome
Timeframe: 1 month following vaccine series completionPopulation: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.
Post dose 3 G2 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Outcome measures
| Measure |
Group A: Standard Dosing
n=27 Participants
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
n=28 Participants
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
G2 Serum-neutralizing Antibody
|
38.7 titers
Interval 25.0 to 59.9
|
33.1 titers
Interval 20.7 to 52.9
|
SECONDARY outcome
Timeframe: 1 month following vaccine series completionPopulation: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.
Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Outcome measures
| Measure |
Group A: Standard Dosing
n=27 Participants
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
n=28 Participants
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
G3 Serum-neutralizing Antibody
|
42.1 titers
Interval 27.5 to 64.6
|
27.3 titers
Interval 17.3 to 43.2
|
SECONDARY outcome
Timeframe: 1 month following vaccine series completionPopulation: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.
Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Outcome measures
| Measure |
Group A: Standard Dosing
n=27 Participants
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
n=28 Participants
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
G4 Serum-neutralizing Antibody
|
144.6 titers
Interval 105.1 to 198.8
|
66.5 titers
Interval 50.7 to 87.1
|
SECONDARY outcome
Timeframe: 1 month following vaccine series completionPopulation: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.
Post dose 3 P1 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Outcome measures
| Measure |
Group A: Standard Dosing
n=27 Participants
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
n=28 Participants
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
P1 Serum-neutralizing Antibody
|
114.7 titers
Interval 77.51 to 169.6
|
136.5 titers
Interval 84.91 to 219.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month following vaccine series completionPopulation: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.
Post dose 3 serum rotavirus Immunoglobulin A geometric mean titer (GMT)
Outcome measures
| Measure |
Group A: Standard Dosing
n=27 Participants
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
n=28 Participants
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
Serum Rotavirus Immunoglobulin A
|
318.3 titers
Interval 179.7 to 563.8
|
183.7 titers
Interval 93.37 to 361.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 days after each dose, up to 10 months post-vaccinationPopulation: Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any does of RV5 will be determined
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined
Outcome measures
| Measure |
Group A: Standard Dosing
n=33 Participants
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
n=33 Participants
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
Reactogenicity Assessment
Fever
|
0.06 Proportion of participants
|
0.03 Proportion of participants
|
|
Reactogenicity Assessment
Vomiting
|
0.15 Proportion of participants
|
0.24 Proportion of participants
|
|
Reactogenicity Assessment
Diarrhea
|
0.21 Proportion of participants
|
0.39 Proportion of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 days after each dose, up to 10 months post-vaccinationProportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined
Outcome measures
| Measure |
Group A: Standard Dosing
n=33 Participants
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
n=33 Participants
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
Adverse Event Assessment
Post dose 1
|
0.27 Proportion of participants
|
0.51 Proportion of participants
|
|
Adverse Event Assessment
Post dose 2
|
0.06 Proportion of participants
|
0.09 Proportion of participants
|
|
Adverse Event Assessment
Post dose 3
|
0.03 Proportion of participants
|
0.06 Proportion of participants
|
|
Adverse Event Assessment
Post any dose
|
0.30 Proportion of participants
|
0.51 Proportion of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After each dose and up to 10 months post-vaccinationProportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined
Outcome measures
| Measure |
Group A: Standard Dosing
n=33 Participants
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
n=33 Participants
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
Serious Adverse Event Assessment
Serious Adverse Event-Post dose 1
|
0 Proportion of participants
|
0 Proportion of participants
|
|
Serious Adverse Event Assessment
Serious Adverse Event-Post dose 2
|
0 Proportion of participants
|
0 Proportion of participants
|
|
Serious Adverse Event Assessment
Serious Adverse Event-Post dose 3
|
0.03 Proportion of participants
|
0 Proportion of participants
|
Adverse Events
Group A: Standard Dosing
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Group B: Alternate Dosing
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Standard Dosing
n=33 participants at risk
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
n=33 participants at risk
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
Other adverse events
| Measure |
Group A: Standard Dosing
n=33 participants at risk
Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
Group B: Alternate Dosing
n=33 participants at risk
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)
|
|---|---|---|
|
Ear and labyrinth disorders
Otitis Media
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
Ear and labyrinth disorders
Ear Drainage
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
6/33 • Number of events 6 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
24.2%
8/33 • Number of events 10 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
Gastrointestinal disorders
Diarrhea
|
21.2%
7/33 • Number of events 7 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
39.4%
13/33 • Number of events 15 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
Gastrointestinal disorders
Gastroenteritis
|
6.1%
2/33 • Number of events 2 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
Gastrointestinal disorders
Change in stool
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
12.1%
4/33 • Number of events 4 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
Gastrointestinal disorders
Gastrointestanal upset
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
General disorders
Colic
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
General disorders
Fever
|
12.1%
4/33 • Number of events 4 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
General disorders
Irritability
|
15.2%
5/33 • Number of events 6 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
15.2%
5/33 • Number of events 6 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
General disorders
Poor weight gain
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
General disorders
Excessive sleepiness
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
General disorders
Sleeplessness
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
General disorders
Change in appetite
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
6.1%
2/33 • Number of events 2 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
Injury, poisoning and procedural complications
Motor vehicale accident
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
12.1%
4/33 • Number of events 4 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
Skin and subcutaneous tissue disorders
Diaper rash
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
|
Skin and subcutaneous tissue disorders
Macule on chin
|
0.00%
0/33 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
3.0%
1/33 • Number of events 1 • 7 days after each dose, up to 10 months post-vaccination
Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place