Trial Outcomes & Findings for Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED) (NCT NCT00718237)

Last Updated: 2017-04-13

Results Overview

Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

762 participants

Primary outcome timeframe

At least 14 days following the 3rd vaccination

Results posted on

2017-04-13

Participant Flow

The study was conducted at 32 sites in Japan from 2008 to 2009.

Excluded from the trial before assignment to groups were subjects with: history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive; immune impairment or resides in a household with an individual with an immune impairment.

Participant milestones

Participant milestones
Measure	RotaTeq™ Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
Overall Study STARTED	381	381
Overall Study Vaccinated at Visit 1	380	381
Overall Study Vaccinated at Visit 2	373	374
Overall Study Vaccinated at Visit 3	371	369
Overall Study COMPLETED	368	366
Overall Study NOT COMPLETED	13	15

Reasons for withdrawal

Reasons for withdrawal
Measure	RotaTeq™ Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
Overall Study Adverse Event	1	3
Overall Study Lost to Follow-up	2	2
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	9	10

Baseline Characteristics

Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RotaTeq™ n=381 Participants Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo n=381 Participants Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.	Total n=762 Participants Total of all reporting groups
Age, Continuous	7.6 Weeks STANDARD_DEVIATION 1.7 • n=5 Participants	7.5 Weeks STANDARD_DEVIATION 1.6 • n=7 Participants	7.5 Weeks STANDARD_DEVIATION 1.6 • n=5 Participants
Age, Customized 6 to 12 Weeks of age	381 participants n=5 Participants	381 participants n=7 Participants	762 participants n=5 Participants
Sex: Female, Male Female	173 Participants n=5 Participants	182 Participants n=7 Participants	355 Participants n=5 Participants
Sex: Female, Male Male	208 Participants n=5 Participants	199 Participants n=7 Participants	407 Participants n=5 Participants

PRIMARY outcome

Timeframe: At least 14 days following the 3rd vaccination

Population: Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).

Outcome measures

Outcome measures
Measure	RotaTeq™ n=355 Participants Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.	Placebo n=356 Participants Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A	7 Number of participants Interval 39.9 to 90.6	27 Number of participants

SECONDARY outcome

Timeframe: At least 14 days following the 3rd vaccination

Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of \>8 and \<=16 was considered moderate, and \>16 was considered severe.

Outcome measures

Outcome measures
Measure	RotaTeq™ n=354 Participants Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.	Placebo n=356 Participants Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A	5 Number of participants Interval 47.4 to 94.1	25 Number of participants

SECONDARY outcome

Timeframe: At least 14 days following the 3rd vaccination

Population: Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool antigen prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).

Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of \>8 and \<=16 was considered moderate, and \>16 was considered severe.

Outcome measures

Outcome measures
Measure	RotaTeq™ n=354 Participants Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.	Placebo n=355 Participants Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A	0 Number of participants Interval 55.4 to 100.0	10 Number of participants

Adverse Events

RotaTeq™

Serious events: 7 serious events

Other events: 179 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 175 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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 Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	RotaTeq™ n=380 participants at risk Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo n=381 participants at risk Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.26% 1/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Congenital, familial and genetic disorders Congenital absence of bile ducts	0.00% 0/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.26% 1/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
General disorders Pyrexia	0.26% 1/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.26% 1/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Infections and infestations Bronchitis	0.26% 1/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.00% 0/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Infections and infestations Bronchitis viral	0.26% 1/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.00% 0/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Infections and infestations Gastroenteritis	0.00% 0/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.26% 1/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Infections and infestations Influenza	0.00% 0/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.26% 1/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Infections and infestations Meningitis coxsackie viral	0.26% 1/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.00% 0/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Infections and infestations Pneumonia	0.26% 1/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.00% 0/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.53% 2/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.00% 0/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Infections and infestations Urinary tract infection	0.00% 0/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.26% 1/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Nervous system disorders Infantile spasms	0.00% 0/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.26% 1/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Psychiatric disorders Psychomotor retardation	0.00% 0/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.26% 1/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.26% 1/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.00% 0/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.26% 1/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/380 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.	0.26% 1/381 • 14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period. Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) during 14 days after each vaccination. Solicited AEs included diarrhea and vomiting. Temperature was also measured daily for 7 days after each vaccination. The number of patients listed "At Risk" is the number of patients who received study treatment.