A study to review the Immunogenicity and Safety of RotaTeq™ (pentavalent rotavirus vaccine) given with Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Japanese Healthy Infants

Phase 1

• Conditions: Prevention of Rotavirus Gastroenteritis Caused by Serotypes G1, G2, G3, G4, and G-Serotypes Associated With P1A [8] (e.g., G9) in Infants; MedDRA version: 19.1Level: LLTClassification code 10039232Term: Rotavirus gastroenteritisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-000277-37-Outside-EU/EEA
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-10
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

1. Healthy Japanese infants.
2. Age 6 weeks through less than 11 weeks (=42 days to =76 days from Date of Birth) at Visit 1.
3. Parent/legal guardian understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent. The parent/guardian may also provide consent for Future Biomedical Research. However, the patient may participate in the main trial without participating in the Future Biomedical Research.

Are the trial subjects under 18? yes
Number of subjects for this age range: 192
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

At Visit 1, subjects should not have any exclusion criteria. As for exclusion criteria with an asterisk [*], if the subject meets this criterion at any visit, the visit may be resche duled when the criterion no longer applies.
1. * Subjects who are clearly feverish, axillary temperature =37.5ºC at the time of vaccination.
2. * Subjects who clearly have acute active disease.
3. Subjects with a history or a risk of hypersensitivity and/or anaphylaxis to any of the product ingredients in V260 and/or DTP-IPV.
4. Subjects with gastrointestinal disorder (active gastrointestinal disease, chronic diarrhea, prior rotavirus gastroenteritis, abdominal surgery), growth retardation, or failure to thrive.
5. Subject with history of intussusception.
6. Subject with untreated congenital gastrointestinal disorder (such as Meckel diverticulum) that may increase the onset of intussusceptions.
7. Known or suspected impairment of immunological function, including severe combined immunodeficiency (SCID).
8. Subjects who have underlying diseases such as cardiovascular, renal, liver, or blood diseases.
9. Subjects with a history of convulsion.
10. Subjects undergoing immunosuppressive therapy (including high -dose systemic corticosteroids [?2mg/kg/day of prednisolone or equivalent] ) or subjects living with a close relative with congenital immune deficiency. Note: Subject using nonsystemic corticosteroids (e.g., topical, ophthalmic, or inhaled) will be eligible for vaccination.
11. Subjects who have received a blood transfusion or blood products, including immunoglobulin.
12. Prior vaccination of rotavirus vaccine and/or DTP-IPV vaccine (including any component of DTP-IPV vaccine).
13. Subjects who have not passed 28 days after live vaccine administration or 7 days after receiving inactivated vaccine.
14. Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study.
15. Subjects who plan to permanently relocate from the area prior to the completion of the study or to leave for an extended period (visiting grandmother’s home) of time when study visits would be scheduled.
16. Subjects who are at high risk of tuberculosis exposure (e.g., subjects living in a household with a person who is under TB treatment or a person with suspected infection with the tubercle bacillus).
17. * Inability to obtain blood specimen at randomization visit. Note: Re-schedule visit so that baseline specimen may be obtained prior to the first vaccination
18. Subjects whom the physician considers unsuitable to vaccinate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified