Trial Outcomes & Findings for 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) (NCT NCT01926015)
NCT ID: NCT01926015
Last Updated: 2018-11-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
192 participants
Primary outcome timeframe
4 to 6 weeks after the third dose of DTP-IPV
Results posted on
2018-11-14
Participant Flow
Participant milestones
| Measure |
Concomitant RotaTeq™ and DTP-IPV
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)
|
Staggered RotaTeq™ and DTP-IPV
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 Study
STARTED
|
96
|
96
|
|
Overall Study
Received >=1 Vaccination
|
94
|
96
|
|
Overall Study
COMPLETED
|
94
|
95
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Concomitant RotaTeq™ and DTP-IPV
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)
|
Staggered RotaTeq™ and DTP-IPV
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 Study
Withdrawal by parent/guardian
|
0
|
1
|
|
Overall Study
Randomized not treated
|
2
|
0
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=96 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=96 Participants
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
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8 Weeks
n=5 Participants
|
9 Weeks
n=7 Participants
|
9 Weeks
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 to 6 weeks after the third dose of DTP-IPVPopulation: 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
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.
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=93 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
|---|---|---|
|
Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
Poliovirus Type 3 NA >=8
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
Diphtheria Toxin >=0.1 IU/mL
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
Tetanus Toxin >=0.01 IU/mL
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
Pertussis Toxin >=10 EU/mL
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
Pertussis FHA >=10 EU/mL
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
Poliovirus Type 1 NA >=8
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
Poliovirus Type 2 NA >=8
|
100 Percentage of participants
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 14 days after any of the 6 study visitsPopulation: 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.
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.
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=96 Participants
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)
|
|---|---|---|
|
Percentage of Participants Reporting an Adverse Event With Incidence >=1%
|
68.1 Percentage of participants
|
86.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=96 Participants
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)
|
|---|---|---|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Fever
Period 1 (up to 14 days after V1 or V2) (n=94, 96)
|
5.3 Percentage of participants
|
6.3 Percentage of participants
|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Fever
Period 2 (up to 14 days after V3 or V4) (n=94, 96)
|
1.1 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Fever
Period 3 (up to 14 days after V5 or V6)(n=94, 95)
|
4.3 Percentage of participants
|
6.3 Percentage of participants
|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Fever
Overall (up to 14 days after any visit)(n=94, 96)
|
10.6 Percentage of participants
|
22.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=96 Participants
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)
|
|---|---|---|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea
Period 1 (up to 14 days after V1 or V2) (n=94, 96)
|
17.0 Percentage of participants
|
31.3 Percentage of participants
|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea
Period 2 (up to 14 days after V3 or V4) (n=94, 96)
|
10.6 Percentage of participants
|
20.8 Percentage of participants
|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea
Period 3 (up to 14 days after V5 or V6) (n=94, 95)
|
7.4 Percentage of participants
|
18.9 Percentage of participants
|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea
Overall (up to 14 days after any visit)(n=94, 96)
|
25.5 Percentage of participants
|
46.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=96 Participants
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)
|
|---|---|---|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting
Period 1 (up to 14 days after V1 or V2) (n=94, 96)
|
5.3 Percentage of participants
|
9.4 Percentage of participants
|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting
Period 2 (up to 14 days after V3 or V4) (n=94, 96)
|
3.2 Percentage of participants
|
6.3 Percentage of participants
|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting
Period 3 (up to 14 days after V5 or V6) (n=94, 95)
|
1.1 Percentage of participants
|
4.2 Percentage of participants
|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting
Overall (up to 14 days after any visit) (n=94, 96)
|
8.5 Percentage of participants
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=96 Participants
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)
|
|---|---|---|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events
Period 1 (up to 14 days after V1 or V2) (n=94, 96)
|
2.1 Percentage of participants
|
4.2 Percentage of participants
|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events
Period 2 (up to 14 days after V3 or V4) (n=94, 96)
|
0.0 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events
Period 3 (up to 14 days after V5 or V6) (n=94, 95)
|
0.0 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events
Overall (up to 14 days after any visit) (n=94, 96)
|
2.1 Percentage of participants
|
10.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPVPopulation: 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
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
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=93 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
|---|---|---|
|
Geometric Mean Titers for Diphtheria Toxin Antibody
Baseline
|
0.025 IU/mL
Interval 0.018 to 0.034
|
0.019 IU/mL
Interval 0.014 to 0.026
|
|
Geometric Mean Titers for Diphtheria Toxin Antibody
4 to 6 weeks after the third dose of DTP-IPV
|
2.377 IU/mL
Interval 2.032 to 2.78
|
2.493 IU/mL
Interval 2.165 to 2.871
|
SECONDARY outcome
Timeframe: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPVPopulation: 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
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
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=93 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
|---|---|---|
|
Geometric Mean Titers for Tetanus Toxin Antibody
Baseline
|
0.082 IU/mL
Interval 0.059 to 0.114
|
0.093 IU/mL
Interval 0.067 to 0.128
|
|
Geometric Mean Titers for Tetanus Toxin Antibody
4 to 6 weeks after the third dose of DTP-IPV
|
1.001 IU/mL
Interval 0.702 to 1.428
|
1.338 IU/mL
Interval 1.009 to 1.774
|
SECONDARY outcome
Timeframe: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPVPopulation: 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
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
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=93 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
|---|---|---|
|
Geometric Mean Titers for Pertussis Toxin Antibody
Baseline
|
2.670 EU/mL
Interval 2.143 to 3.328
|
2.757 EU/mL
Interval 2.278 to 3.338
|
|
Geometric Mean Titers for Pertussis Toxin Antibody
4 to 6 weeks after the third dose of DTP-IPV
|
198.811 EU/mL
Interval 177.43 to 222.768
|
241.857 EU/mL
Interval 218.225 to 268.049
|
SECONDARY outcome
Timeframe: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPVPopulation: 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
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
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=93 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
|---|---|---|
|
Geometric Mean Titers for Pertussis FHA Antibody
Baseline
|
7.513 EU/mL
Interval 6.285 to 8.98
|
6.951 EU/mL
Interval 5.703 to 8.472
|
|
Geometric Mean Titers for Pertussis FHA Antibody
4 to 6 weeks after the third dose of DTP-IPV
|
77.386 EU/mL
Interval 67.959 to 88.119
|
88.275 EU/mL
Interval 76.065 to 102.445
|
SECONDARY outcome
Timeframe: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPVPopulation: 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
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.
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=93 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
|---|---|---|
|
Geometric Mean Titers for Poliovirus Type 1 Antibody
Baseline
|
23.5 NA Titer
Interval 17.21 to 32.05
|
21.1 NA Titer
Interval 15.47 to 28.76
|
|
Geometric Mean Titers for Poliovirus Type 1 Antibody
4 to 6 weeks after the third dose of DTP-IPV
|
1578 NA Titer
Interval 1237.3 to 2012.0
|
1703 NA Titer
Interval 1314.4 to 2207.0
|
SECONDARY outcome
Timeframe: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPVPopulation: 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
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.
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=93 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
|---|---|---|
|
Geometric Mean Titers for Poliovirus Type 2 Antibody
Baseline
|
32.0 NA Titer
Interval 23.97 to 42.72
|
27.8 NA Titer
Interval 20.64 to 37.49
|
|
Geometric Mean Titers for Poliovirus Type 2 Antibody
4 to 6 weeks after the third dose of DTP-IPV
|
2886 NA Titer
Interval 2346.9 to 3547.8
|
3259 NA Titer
Interval 2678.2 to 3965.8
|
SECONDARY outcome
Timeframe: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPVPopulation: 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
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.
Outcome measures
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=93 Participants
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)
|
Staggered RotaTeq™ and DTP-IPV
n=94 Participants
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)
|
|---|---|---|
|
Geometric Mean Titers for Poliovirus Type 3 Antibody
Baseline
|
3.9 NA Titer
Interval 3.43 to 4.43
|
4.8 NA Titer
Interval 3.92 to 5.85
|
|
Geometric Mean Titers for Poliovirus Type 3 Antibody
4 to 6 weeks after the third dose of DTP-IPV
|
2377 NA Titer
Interval 1973.1 to 2864.0
|
2671 NA Titer
Interval 2193.5 to 3251.5
|
Adverse Events
Concomitant RotaTeq™ and DTP-IPV
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Staggered RotaTeq™ and DTP-IPV
Serious events: 2 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=94 participants at risk
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)
|
Staggered RotaTeq™ and DTP-IPV
n=96 participants at risk
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)
|
|---|---|---|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
1.0%
1/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
1.0%
1/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
Other adverse events
| Measure |
Concomitant RotaTeq™ and DTP-IPV
n=94 participants at risk
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)
|
Staggered RotaTeq™ and DTP-IPV
n=96 participants at risk
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)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
25.5%
24/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
46.9%
45/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
Gastrointestinal disorders
Infantile spitting up
|
0.00%
0/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
6.2%
6/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
Gastrointestinal disorders
Vomiting
|
8.5%
8/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
16.7%
16/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
General disorders
Injection site erythema
|
2.1%
2/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
5.2%
5/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
General disorders
Pyrexia
|
10.6%
10/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
22.9%
22/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.4%
7/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
7.3%
7/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
9.6%
9/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
12.5%
12/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
6.4%
6/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
9.4%
9/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
7.4%
7/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
7.3%
7/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Bronchitis
|
5.3%
5/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
4.2%
4/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Conjunctivitis
|
2.1%
2/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
6.2%
6/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
7/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
20.8%
20/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Upper respiratory tract infection
|
9.6%
9/94 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
12.5%
12/96 • 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
The safety population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER