A study of RotaTeq™ (pentavalent rotavirus vaccine) in Chinese healthy adults, children and 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: EUCTR2017-000263-32-Outside-EU/EEA
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-07
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. Healthy adults ages 19 to 47 years for Cohort I.
2. Healthy children ages 2 to 6 years for Cohort II.
3. Healthy infants ages 6 to 12 weeks (=42 to =84 days) for Cohort III.
4. Subjects (or parents/legal guardians for subjects of Cohort II and Cohort III) who fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent.
5. Subjects who are healthy based on the information collected on the medical history and physical examination.
6. Negative urine -hCG test result for premenopausal female subjects of Cohort I.
7. Premenopausal female subjects of Cohort I who have had sexual intercourse in the two weeks prior to enrollment must have been using effective contraception. Effective contraception will be considered to include oral birth control pills or at least single-barrier contraception (partner using condom or subject using diaphragm, contraceptive sponge, or intrauterine device (IUD), etc. Emergency contraception is not considered effective contraception for enrollment in the study).

Are the trial subjects under 18? yes
Number of subjects for this age range: 96
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects in Cohort I and Cohort II receiving any vaccine within 14 days prior to enrollment or anticipated to receive any vaccine 14 days after the V260/placebo dose.
2. Subjects in Cohort III, who anticipate receiving non-concomitant administration of any live vaccines (e.g., OPV) within 14 days prior to or after any V260/placebo dose. [Note: concomitant administration with dosing of V260/placebo on the same day as other usual childhood (EPI) vaccines, including OPV, is allowed and strongly encouraged.]
3. History of known gastrointestinal diseases/bleeding, chronic diarrhea, congenital abdominal disorders, intussusception, abdominal surgery, irritable bowel syndrome (IBS), colitis, diverticulitis.
4. Known or suspected impairment of immunological function.
5. Known hypersensitivity to any component of the rotavirus vaccine, Individuals who develop symptoms suggestive of hypersensitivity after receiving a dose of study vaccine should not receive further doses, e.g., purified sucrose, sodium citrate, sodium phosphate, sodium hydroxide, surface active agent (Polysorbate 80), and inorganic salts, amino acids, and vitamins contained in the culture media for tissue culture used in the manufacturing process of a vaccine.
6. History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty with breathing, hypotension, or shock) that required medical intervention.
7. Prior administration of any rotavirus vaccines.
8. Elevated temperature, with axillary temperature =37.1ºC for subjects of Cohort I, Cohort II, and Cohort III, within 24 hours prior to vaccination.
9. Subjects participating in Group III only, history of known prior rotavirus disease, chronic diarrhea, or failure to thrive prior to vaccination.
10. Clinical evidence of active gastrointestinal illness. (Note that infants with gastroesophageal reflux disease [GERD] may participate in the study as long as the GERD is well controlled with or without medication.)
11. Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination. (Note that subjects on inhaled steroids may participate in the study.)
12. Residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or with those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids.
13. Subjects participating in Cohort III, any prior receipt of a blood transfusion or blood products, including immunoglobulins.
14. Subjects who cannot be adequately followed for safety by telephone or home visit.
15. Any condition, which, in the primary investigator’s opinion, may interfere with the evaluation of the study objectives.
16. Female subjects participating in Cohort I, pregnancy or expecting to conceive during the study period. (Female subjects of child-bearing age and capacity must agree to use effective contraception for 3 months after administration of the study vaccine/placebo. Abstinence is considered an acceptable method of birth control).
17. Subjects participating in Cohort I, history of drug or alcohol abuse.
18. Subjects who plan to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that V260 is generally well-tolerated in the Chinese healthy population, especially with respect to serious adverse experiences (SAEs) that occur within 14 days following vaccination.;Secondary Objective: To summarize the fecal vaccine virus shedding rate in the targeted population (infants).;Primary end point(s): Safety information regarding all adverse experiences with concentration on elevated temperature, vomiting, and diarrhea will be collected daily for 14 days (Day 1-14) following each dose of V260/placebo using Vaccination Report Card (VRC) starting with the date of vaccination;Timepoint(s) of evaluation of this end point: 28 weeks (14 day period following any dose)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A