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An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01960725
Recruitment Status : Completed
First Posted : October 11, 2013
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dennis Clements, Duke University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Diarrhea
Gastroenteritis
Intervention Biological: RV5 (Pentavalent Rotavirus Vaccine)
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A: Standard Dosing Group B: Alternate Dosing
Hide Arm/Group Description

Group will receive RV5 vaccine at 2, 4, and 6 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Period Title: Overall Study
Started 33 33
Received First Vaccine 33 33
Recieved Second Vaccine 33 33
Received Third Vaccine 32 32
Completed [1] 27 28
Not Completed 6 5
Reason Not Completed
Lost to Follow-up             4             3
Withdrawal by Subject             1             0
unable to obtain blood sample             1             2
[1]
Immunogenicity data completed
Arm/Group Title Group A: Standard Dosing Group B: Alternate Dosing Total
Hide Arm/Group Description

Group will receive RV5 vaccine at 2, 4, and 6 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Total of all reporting groups
Overall Number of Baseline Participants 33 33 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 33 participants 33 participants 66 participants
63  (4.6) 26.6  (7.3) 44.8  (19.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
Female
19
  57.6%
21
  63.6%
40
  60.6%
Male
14
  42.4%
12
  36.4%
26
  39.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
Asian 0 2 2
White 24 27 51
African American 9 4 13
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
Hispanic 3 3 6
Non-Hispanic 30 30 60
1.Primary Outcome
Title G1 Serum-neutralizing Antibody
Hide Description Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)
Time Frame 1 month following vaccine series completion
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A: Standard Dosing Group B: Alternate Dosing
Hide Arm/Group Description:

Group will receive RV5 vaccine at 2, 4, and 6 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Overall Number of Participants Analyzed 27 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
188
(117.9 to 299.7)
184.5
(117 to 290.8)
2.Secondary Outcome
Title G2 Serum-neutralizing Antibody
Hide Description Post dose 3 G2 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Time Frame 1 month following vaccine series completion
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A: Standard Dosing Group B: Alternate Dosing
Hide Arm/Group Description:

Group will receive RV5 vaccine at 2, 4, and 6 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Overall Number of Participants Analyzed 27 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
38.7
(25 to 59.9)
33.1
(20.7 to 52.9)
3.Secondary Outcome
Title G3 Serum-neutralizing Antibody
Hide Description Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Time Frame 1 month following vaccine series completion
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A: Standard Dosing Group B: Alternate Dosing
Hide Arm/Group Description:

Group will receive RV5 vaccine at 2, 4, and 6 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Overall Number of Participants Analyzed 27 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
42.1
(27.5 to 64.6)
27.3
(17.3 to 43.2)
4.Secondary Outcome
Title G4 Serum-neutralizing Antibody
Hide Description Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Time Frame 1 month following vaccine series completion
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A: Standard Dosing Group B: Alternate Dosing
Hide Arm/Group Description:

Group will receive RV5 vaccine at 2, 4, and 6 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Overall Number of Participants Analyzed 27 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
144.6
(105.1 to 198.8)
66.5
(50.7 to 87.1)
5.Secondary Outcome
Title P1 Serum-neutralizing Antibody
Hide Description Post dose 3 P1 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Time Frame 1 month following vaccine series completion
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A: Standard Dosing Group B: Alternate Dosing
Hide Arm/Group Description:

Group will receive RV5 vaccine at 2, 4, and 6 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Overall Number of Participants Analyzed 27 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
114.7
(77.51 to 169.6)
136.5
(84.91 to 219.3)
6.Other Pre-specified Outcome
Title Serum Rotavirus Immunoglobulin A
Hide Description Post dose 3 serum rotavirus Immunoglobulin A geometric mean titer (GMT)
Time Frame 1 month following vaccine series completion
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A: Standard Dosing Group B: Alternate Dosing
Hide Arm/Group Description:

Group will receive RV5 vaccine at 2, 4, and 6 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Overall Number of Participants Analyzed 27 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
318.3
(179.7 to 563.8)
183.7
(93.37 to 361.6)
7.Other Pre-specified Outcome
Title Reactogenicity Assessment
Hide Description 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
Time Frame 7 days after each dose, up to 10 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Group A: Standard Dosing Group B: Alternate Dosing
Hide Arm/Group Description:

Group will receive RV5 vaccine at 2, 4, and 6 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Overall Number of Participants Analyzed 33 33
Measure Type: Number
Unit of Measure: Proportion of participants
Fever 0.06 0.03
Vomiting 0.15 0.24
Diarrhea 0.21 0.39
8.Other Pre-specified Outcome
Title Adverse Event Assessment
Hide Description Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined
Time Frame 28 days after each dose, up to 10 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: Standard Dosing Group B: Alternate Dosing
Hide Arm/Group Description:

Group will receive RV5 vaccine at 2, 4, and 6 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Overall Number of Participants Analyzed 33 33
Measure Type: Number
Unit of Measure: Proportion of participants
Post dose 1 0.27 0.51
Post dose 2 0.06 0.09
Post dose 3 0.03 0.06
Post any dose 0.30 0.51
9.Other Pre-specified Outcome
Title Serious Adverse Event Assessment
Hide Description Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined
Time Frame After each dose and up to 10 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: Standard Dosing Group B: Alternate Dosing
Hide Arm/Group Description:

Group will receive RV5 vaccine at 2, 4, and 6 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Overall Number of Participants Analyzed 33 33
Measure Type: Number
Unit of Measure: Proportion of participants
Serious Adverse Event-Post dose 1 0 0
Serious Adverse Event-Post dose 2 0 0
Serious Adverse Event-Post dose 3 0.03 0
Time Frame 7 days after each dose, up to 10 months post-vaccination
Adverse Event Reporting Description 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.
 
Arm/Group Title Group A: Standard Dosing Group B: Alternate Dosing
Hide Arm/Group Description

Group will receive RV5 vaccine at 2, 4, and 6 months of age

RV5 (Pentavalent Rotavirus Vaccine)

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

RV5 (Pentavalent Rotavirus Vaccine)

All-Cause Mortality
Group A: Standard Dosing Group B: Alternate Dosing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Group A: Standard Dosing Group B: Alternate Dosing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/33 (3.03%)      0/33 (0.00%)    
Gastrointestinal disorders     
Gastroenteritis   1/33 (3.03%)  1 0/33 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A: Standard Dosing Group B: Alternate Dosing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/33 (30.30%)      17/33 (51.52%)    
Ear and labyrinth disorders     
Otitis Media   0/33 (0.00%)  0 1/33 (3.03%)  1
Ear Drainage   0/33 (0.00%)  0 1/33 (3.03%)  1
Gastrointestinal disorders     
Vomiting   6/33 (18.18%)  6 8/33 (24.24%)  10
Diarrhea   7/33 (21.21%)  7 13/33 (39.39%)  15
Gastroenteritis   2/33 (6.06%)  2 0/33 (0.00%)  0
Change in stool   1/33 (3.03%)  1 4/33 (12.12%)  4
Constipation   0/33 (0.00%)  0 1/33 (3.03%)  1
Gastrointestanal upset   0/33 (0.00%)  0 1/33 (3.03%)  1
General disorders     
Colic   0/33 (0.00%)  0 1/33 (3.03%)  1
Fever   4/33 (12.12%)  4 1/33 (3.03%)  1
Irritability   5/33 (15.15%)  6 5/33 (15.15%)  6
Poor weight gain   0/33 (0.00%)  0 1/33 (3.03%)  1
Excessive sleepiness   0/33 (0.00%)  0 1/33 (3.03%)  1
Sleeplessness   0/33 (0.00%)  0 1/33 (3.03%)  1
Change in appetite   0/33 (0.00%)  0 2/33 (6.06%)  2
Injury, poisoning and procedural complications     
Motor vehicale accident   0/33 (0.00%)  0 1/33 (3.03%)  1
Respiratory, thoracic and mediastinal disorders     
URI   0/33 (0.00%)  0 4/33 (12.12%)  4
Skin and subcutaneous tissue disorders     
Diaper rash   1/33 (3.03%)  1 1/33 (3.03%)  1
Macule on chin   0/33 (0.00%)  0 1/33 (3.03%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dennis Clements
Organization: Duke University School of Medicine
Phone: 919-684-7790
EMail: dennis.clements@duke.edu
Layout table for additonal information
Responsible Party: Dennis Clements, Duke University
ClinicalTrials.gov Identifier: NCT01960725    
Other Study ID Numbers: Pro00049081
MISP-50891 ( Other Grant/Funding Number: Merck Investigator Studies Program )
First Submitted: October 7, 2013
First Posted: October 11, 2013
Results First Submitted: November 8, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017