Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)

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: NCT01926015
Recruitment Status : Completed
First Posted : August 20, 2013
Results First Posted : April 9, 2015
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Rotavirus Disease
Interventions Biological: RotaTeq™ (V260)
Biological: DTP-IPV
Enrollment 192
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Period Title: Overall Study
Started 96 [1] 96 [1]
Received >=1 Vaccination 94 96
Completed 94 95
Not Completed 2 1
Reason Not Completed
Withdrawal by parent/guardian             0             1
Randomized not treated             2             0
[1]
Participants who passed all entry criteria and who were randomized into the study
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV Total
Hide Arm/Group Description RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) Total of all reporting groups
Overall Number of Baseline Participants 96 96 192
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 96 participants 96 participants 192 participants
8
(6 to 10)
9
(6 to 10)
9
(6 to 10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 96 participants 192 participants
Female
47
  49.0%
41
  42.7%
88
  45.8%
Male
49
  51.0%
55
  57.3%
104
  54.2%
1.Primary Outcome
Title Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
Hide Description Participant serum was collected for determination of antibody responses. Threshold levels for seroresponse were the following: Diphtheria Toxin, >=0.1 International Units (IU)/mL; Tetanus Toxin, >=0.01 IU/mL; Pertussis Toxin and Pertussis FHA, >=10 Enzyme Units (EU)/mL; Poliovirus Types 1, 2, and 3, neutralizing antibody (NA) titer >=8.
Time Frame 4 to 6 weeks after the third dose of DTP-IPV
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 93 94
Measure Type: Number
Unit of Measure: Percentage of participants
Diphtheria Toxin >=0.1 IU/mL 100 100
Tetanus Toxin >=0.01 IU/mL 100 100
Pertussis Toxin >=10 EU/mL 100 100
Pertussis FHA >=10 EU/mL 100 100
Poliovirus Type 1 NA >=8 100 100
Poliovirus Type 2 NA >=8 100 100
Poliovirus Type 3 NA >=8 100 100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Concomitant RotaTeq™ and DTP-IPV, Staggered RotaTeq™ and DTP-IPV
Comments Diphtheria Toxin >=0.1 IU/mL
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-3.99 to 3.95
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Concomitant RotaTeq™ and DTP-IPV, Staggered RotaTeq™ and DTP-IPV
Comments Tetanus Toxin >=0.01 IU/mL
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-3.99 to 3.95
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Concomitant RotaTeq™ and DTP-IPV, Staggered RotaTeq™ and DTP-IPV
Comments Pertussis Toxin >=10 EU/mL
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-3.99 to 3.95
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Concomitant RotaTeq™ and DTP-IPV, Staggered RotaTeq™ and DTP-IPV
Comments Pertussis FHA >=10 EU/mL
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-3.99 to 3.95
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Concomitant RotaTeq™ and DTP-IPV, Staggered RotaTeq™ and DTP-IPV
Comments Poliovirus Type 1 NA >=8
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-3.99 to 3.95
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Concomitant RotaTeq™ and DTP-IPV, Staggered RotaTeq™ and DTP-IPV
Comments Poliovirus Type 2 NA >=8
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-3.99 to 3.95
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Concomitant RotaTeq™ and DTP-IPV, Staggered RotaTeq™ and DTP-IPV
Comments Poliovirus Type 3 NA >=8
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-3.99 to 3.95
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Reporting an Adverse Event With Incidence >=1%
Hide Description An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events with an incidence >=1% in either treatment group were recorded.
Time Frame Up to 14 days after any of the 6 study visits
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was were counted only once overall.
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 94 96
Measure Type: Number
Unit of Measure: Percentage of participants
68.1 86.5
3.Secondary Outcome
Title Percentage of Participants Reporting an Adverse Event of Special Interest: Fever
Hide Description An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.
Time Frame Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was counted only once within a study Period and only once Overall.
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 94 96
Measure Type: Number
Unit of Measure: Percentage of participants
Period 1 (up to 14 days after V1 or V2) (n=94, 96) 5.3 6.3
Period 2 (up to 14 days after V3 or V4) (n=94, 96) 1.1 12.5
Period 3 (up to 14 days after V5 or V6)(n=94, 95) 4.3 6.3
Overall (up to 14 days after any visit)(n=94, 96) 10.6 22.9
4.Secondary Outcome
Title Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea
Hide Description An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.
Time Frame Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 94 96
Measure Type: Number
Unit of Measure: Percentage of participants
Period 1 (up to 14 days after V1 or V2) (n=94, 96) 17.0 31.3
Period 2 (up to 14 days after V3 or V4) (n=94, 96) 10.6 20.8
Period 3 (up to 14 days after V5 or V6) (n=94, 95) 7.4 18.9
Overall (up to 14 days after any visit)(n=94, 96) 25.5 46.9
5.Secondary Outcome
Title Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting
Hide Description An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.
Time Frame Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 94 96
Measure Type: Number
Unit of Measure: Percentage of participants
Period 1 (up to 14 days after V1 or V2) (n=94, 96) 5.3 9.4
Period 2 (up to 14 days after V3 or V4) (n=94, 96) 3.2 6.3
Period 3 (up to 14 days after V5 or V6) (n=94, 95) 1.1 4.2
Overall (up to 14 days after any visit) (n=94, 96) 8.5 16.7
6.Secondary Outcome
Title Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events
Hide Description An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.
Time Frame Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 94 96
Measure Type: Number
Unit of Measure: Percentage of participants
Period 1 (up to 14 days after V1 or V2) (n=94, 96) 2.1 4.2
Period 2 (up to 14 days after V3 or V4) (n=94, 96) 0.0 8.3
Period 3 (up to 14 days after V5 or V6) (n=94, 95) 0.0 2.1
Overall (up to 14 days after any visit) (n=94, 96) 2.1 10.4
7.Secondary Outcome
Title Geometric Mean Titers for Diphtheria Toxin Antibody
Hide Description Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Time Frame Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 93 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Baseline
0.025
(0.018 to 0.034)
0.019
(0.014 to 0.026)
4 to 6 weeks after the third dose of DTP-IPV
2.377
(2.032 to 2.780)
2.493
(2.165 to 2.871)
8.Secondary Outcome
Title Geometric Mean Titers for Tetanus Toxin Antibody
Hide Description Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Time Frame Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 93 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Baseline
0.082
(0.059 to 0.114)
0.093
(0.067 to 0.128)
4 to 6 weeks after the third dose of DTP-IPV
1.001
(0.702 to 1.428)
1.338
(1.009 to 1.774)
9.Secondary Outcome
Title Geometric Mean Titers for Pertussis Toxin Antibody
Hide Description Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Time Frame Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 93 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Baseline
2.670
(2.143 to 3.328)
2.757
(2.278 to 3.338)
4 to 6 weeks after the third dose of DTP-IPV
198.811
(177.430 to 222.768)
241.857
(218.225 to 268.049)
10.Secondary Outcome
Title Geometric Mean Titers for Pertussis FHA Antibody
Hide Description Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Time Frame Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 93 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Baseline
7.513
(6.285 to 8.980)
6.951
(5.703 to 8.472)
4 to 6 weeks after the third dose of DTP-IPV
77.386
(67.959 to 88.119)
88.275
(76.065 to 102.445)
11.Secondary Outcome
Title Geometric Mean Titers for Poliovirus Type 1 Antibody
Hide Description Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.
Time Frame Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 93 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: NA Titer
Baseline
23.5
(17.21 to 32.05)
21.1
(15.47 to 28.76)
4 to 6 weeks after the third dose of DTP-IPV
1578
(1237.3 to 2012.0)
1703
(1314.4 to 2207.0)
12.Secondary Outcome
Title Geometric Mean Titers for Poliovirus Type 2 Antibody
Hide Description Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.
Time Frame Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 93 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: NA Titer
Baseline
32.0
(23.97 to 42.72)
27.8
(20.64 to 37.49)
4 to 6 weeks after the third dose of DTP-IPV
2886
(2346.9 to 3547.8)
3259
(2678.2 to 3965.8)
13.Secondary Outcome
Title Geometric Mean Titers for Poliovirus Type 3 Antibody
Hide Description Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.
Time Frame Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description:
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
Overall Number of Participants Analyzed 93 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: NA Titer
Baseline
3.9
(3.43 to 4.43)
4.8
(3.92 to 5.85)
4 to 6 weeks after the third dose of DTP-IPV
2377
(1973.1 to 2864.0)
2671
(2193.5 to 3251.5)
Time Frame All adverse events: up to 14 days after any study visit; all deaths, vaccine-related serious adverse events, overdoses, and intussusception: up to 26 weeks after Visit 1
Adverse Event Reporting Description The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up
 
Arm/Group Title Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Hide Arm/Group Description RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
All-Cause Mortality
Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Affected / at Risk (%) Affected / at Risk (%)
Total   0/94 (0.00%)   2/96 (2.08%) 
Infections and infestations     
Pneumonia respiratory syncytial viral  1  0/94 (0.00%)  1/96 (1.04%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract inflammation  1  0/94 (0.00%)  1/96 (1.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Concomitant RotaTeq™ and DTP-IPV Staggered RotaTeq™ and DTP-IPV
Affected / at Risk (%) Affected / at Risk (%)
Total   57/94 (60.64%)   79/96 (82.29%) 
Gastrointestinal disorders     
Diarrhoea  1  24/94 (25.53%)  45/96 (46.88%) 
Infantile spitting up  1  0/94 (0.00%)  6/96 (6.25%) 
Vomiting  1  8/94 (8.51%)  16/96 (16.67%) 
General disorders     
Injection site erythema  1  2/94 (2.13%)  5/96 (5.21%) 
Pyrexia  1  10/94 (10.64%)  22/96 (22.92%) 
Infections and infestations     
Bronchitis  1  5/94 (5.32%)  4/96 (4.17%) 
Conjunctivitis  1  2/94 (2.13%)  6/96 (6.25%) 
Nasopharyngitis  1  7/94 (7.45%)  20/96 (20.83%) 
Upper respiratory tract infection  1  9/94 (9.57%)  12/96 (12.50%) 
Respiratory, thoracic and mediastinal disorders     
Rhinorrhoea  1  7/94 (7.45%)  7/96 (7.29%) 
Upper respiratory tract inflammation  1  9/94 (9.57%)  12/96 (12.50%) 
Skin and subcutaneous tissue disorders     
Dermatitis diaper  1  6/94 (6.38%)  9/96 (9.38%) 
Eczema infantile  1  7/94 (7.45%)  7/96 (7.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01926015     History of Changes
Other Study ID Numbers: V260-060
132252 ( Registry Identifier: JAPIC-CTI )
First Submitted: August 16, 2013
First Posted: August 20, 2013
Results First Submitted: March 27, 2015
Results First Posted: April 9, 2015
Last Update Posted: November 14, 2018