Phase 4
N=192
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)
Rotavirus Disease
Bottom Line
View on ClinicalTrials.gov: NCT01926015 ↗Enrolled (actual)
192
Serious AEs
1.1%
Results posted
Apr 2015
Primary outcome: Primary: Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3 — 100; 100; 100; 100 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- RotaTeq™ (V260) (Biological); DTP-IPV (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3 |
100; 100; 100; 100; 100; 100 | <0.001 sig |
| SECONDARY Percentage of Participants Reporting an Adverse Event With Incidence >=1% |
68.1; 86.5 | — |
| SECONDARY Percentage of Participants Reporting an Adverse Event of Special Interest: Fever |
5.3; 6.3; 1.1; 12.5; 4.3; 6.3 | — |
| SECONDARY Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea |
17.0; 31.3; 10.6; 20.8; 7.4; 18.9 | — |
| SECONDARY Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting |
5.3; 9.4; 3.2; 6.3; 1.1; 4.2 | — |
| SECONDARY Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events |
2.1; 4.2; 0.0; 8.3; 0.0; 2.1 | — |
| SECONDARY Geometric Mean Titers for Diphtheria Toxin Antibody |
0.025; 0.019; 2.377; 2.493 | — |
| SECONDARY Geometric Mean Titers for Tetanus Toxin Antibody |
0.082; 0.093; 1.001; 1.338 | — |
| SECONDARY Geometric Mean Titers for Pertussis Toxin Antibody |
2.670; 2.757; 198.811; 241.857 | — |
| SECONDARY Geometric Mean Titers for Pertussis FHA Antibody |
7.513; 6.951; 77.386; 88.275 | — |
| SECONDARY Geometric Mean Titers for Poliovirus Type 1 Antibody |
23.5; 21.1; 1578; 1703 | — |
| SECONDARY Geometric Mean Titers for Poliovirus Type 2 Antibody |
32.0; 27.8; 2886; 3259 | — |
| SECONDARY Geometric Mean Titers for Poliovirus Type 3 Antibody |
3.9; 4.8; 2377; 2671 | — |
Summary
The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260) in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with staggered administration of RotaTeq™.
Eligibility Criteria
Inclusion Criteria
- Japanese participant
- Age 6 weeks through <11 weeks (42 to 76 days from date of birth) at Visit 1
Exclusion Criteria
- History of hypersensitivity and/or anaphylaxis to any of the product ingredients in V260 or DTP-IPV
- Gastrointestinal disorder, growth retardation, or failure to thrive
- History of intussusception
- Untreated congenital gastrointestinal disorder (such as Meckel diverticulum)
- Known or suspected impairment of immunological function, including severe immunodeficiency (SCID)
- Cardiovascular, renal, liver, or blood disease
- History of convulsion
- Undergoing immunosuppressive therapy or living with a close relative with congenital immune deficiency
- Prior vaccination with rotavirus vaccine and/or DTP-IPV vaccine
- Live vaccine received within 28 days or inactivated vaccine received within 7 days
- At high risk for tuberculosis exposure
Data sourced from ClinicalTrials.gov (NCT01926015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.