Trial Outcomes & Findings for ROTATEQ Reexamination Study (V260-037) (NCT NCT01074242)

Results Overview

An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.

Recruitment status

COMPLETED

Target enrollment

3798 participants

Primary outcome timeframe

Up to 42 days after any Rotateq vaccination

Results posted on

2017-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Rotateq Korean infants vaccinated with Rotateq in usual practice
Overall Study STARTED	3798
Overall Study Received at Least 1 Dose of Vaccine	3395
Overall Study COMPLETED	3395
Overall Study NOT COMPLETED	403

Reasons for withdrawal

Reasons for withdrawal
Measure	Rotateq Korean infants vaccinated with Rotateq in usual practice
Overall Study Case report before date of contract	40
Overall Study Lost to Follow-up	1
Overall Study Case report unclear	6
Overall Study Violation of vaccine dose or dosage	351
Overall Study Duplicate Case Report Form	5

Baseline Characteristics

ROTATEQ Reexamination Study (V260-037)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rotateq n=3395 Participants Korean infants vaccinated with Rotateq in usual practice
Age, Continuous	9.57 Weeks STANDARD_DEVIATION 1.03 • n=99 Participants
Age, Customized <8 weeks	90 Participants n=99 Participants
Age, Customized Between 8 and 10 weeks	2740 Participants n=99 Participants
Age, Customized >10 weeks	565 Participants n=99 Participants
Sex: Female, Male Female	1692 Participants n=99 Participants
Sex: Female, Male Male	1703 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 42 days after any Rotateq vaccination

Population: All enrolled participants who received at least 1 dose of study vaccine were included in the analysis

An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.

Outcome measures

Outcome measures
Measure	Rotateq n=3395 Participants Korean infants vaccinated with Rotateq in usual practice
Percentage of Participants With Any Adverse Experience	22.12 Percent of participants

PRIMARY outcome

Timeframe: Up to 42 days after any Rotateq vaccination

Population: All enrolled participants who received at least 1 dose of study vaccine were included in the analysis

An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out

Outcome measures

Outcome measures
Measure	Rotateq n=3395 Participants Korean infants vaccinated with Rotateq in usual practice
Percentage of Participants With Any Adverse Drug Reaction	4.27 Percent of participants

Adverse Events

Rotateq

Serious events: 8 serious events

Other events: 210 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rotateq n=3395 participants at risk Korean infants vaccinated with Rotateq in usual practice
Infections and infestations Gastroenteritis	0.03% 1/3395 • Number of events 1 • Up to 42 days after any Rotateq vaccination All enrolled participants who received at least 1 dose of study vaccine were included in the analysis
Infections and infestations Laryngitis	0.03% 1/3395 • Number of events 1 • Up to 42 days after any Rotateq vaccination All enrolled participants who received at least 1 dose of study vaccine were included in the analysis
Infections and infestations Pneumonia	0.09% 3/3395 • Number of events 4 • Up to 42 days after any Rotateq vaccination All enrolled participants who received at least 1 dose of study vaccine were included in the analysis
Infections and infestations Urinary tract infection	0.09% 3/3395 • Number of events 3 • Up to 42 days after any Rotateq vaccination All enrolled participants who received at least 1 dose of study vaccine were included in the analysis
Gastrointestinal disorders Enteritis	0.03% 1/3395 • Number of events 1 • Up to 42 days after any Rotateq vaccination All enrolled participants who received at least 1 dose of study vaccine were included in the analysis
General disorders Pyrexia	0.03% 1/3395 • Number of events 1 • Up to 42 days after any Rotateq vaccination All enrolled participants who received at least 1 dose of study vaccine were included in the analysis

Other adverse events

Other adverse events
Measure	Rotateq n=3395 participants at risk Korean infants vaccinated with Rotateq in usual practice
Infections and infestations Nasopharyngitis	6.2% 210/3395 • Number of events 263 • Up to 42 days after any Rotateq vaccination All enrolled participants who received at least 1 dose of study vaccine were included in the analysis

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 In regard to surveillance results, any publication should be agreed by the sponsor in advance
Publication restrictions are in place

Restriction type: OTHER