Trial Outcomes & Findings for A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED) (NCT NCT01077804)

Results Overview

Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with "any symptoms") were reported by parents during the interview. No medical confirmation of the diagnosis was required.

Recruitment status

COMPLETED

Target enrollment

7585 participants

Primary outcome timeframe

From 6 weeks to 168 months (14 years) post vaccination

Results posted on

2017-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Varivax Vaccinated Children Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
Overall Study STARTED	7585
Overall Study COMPLETED	7386
Overall Study NOT COMPLETED	199

Reasons for withdrawal

Reasons for withdrawal
Measure	Varivax Vaccinated Children Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
Overall Study Unreachable	102
Overall Study Refused to continue	79
Overall Study Other	18

Baseline Characteristics

A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varivax Vaccinated Children n=7585 Participants Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
Age, Customized	7585 Participants n=5 Participants
Sex: Female, Male Female	3714 Participants n=5 Participants
Sex: Female, Male Male	3871 Participants n=5 Participants
Region of Enrollment United States	7585 participants n=5 Participants

PRIMARY outcome

Timeframe: From 6 weeks to 168 months (14 years) post vaccination

Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with "any symptoms") were reported by parents during the interview. No medical confirmation of the diagnosis was required.

Outcome measures

Outcome measures
Measure	Varivax Vaccinated Children n=7585 Participants Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
Number of Participants With an Occurrence of Breakthrough Varicella Any Varicella symptoms	1425 Participants
Number of Participants With an Occurrence of Breakthrough Varicella Varicella with >50 lesions	362 Participants
Number of Participants With an Occurrence of Breakthrough Varicella Varicella with >300 lesions	28 Participants

PRIMARY outcome

Timeframe: From 6 weeks to 168 months (14 years) post vaccination

Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with "any symptoms") were reported by parents during the interview. No medical confirmation of the diagnosis was required.

Outcome measures

Outcome measures
Measure	Varivax Vaccinated Children n=7585 Participants Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
Incidence Rate of Breakthrough Varicella Any varicella	15.9 Rate per 1000 person years Interval 15.1 to 16.7
Incidence Rate of Breakthrough Varicella Varicella with > 50 lesions	4 Rate per 1000 person years Interval 3.6 to 4.9
Incidence Rate of Breakthrough Varicella Varicella with > 300 lesions	0.3 Rate per 1000 person years Interval 0.2 to 0.5

SECONDARY outcome

Timeframe: From 6 weeks to 168 months (14 years) post vaccination

Herpes zoster cases were physician-diagnosed cases.

Outcome measures

Outcome measures
Measure	Varivax Vaccinated Children n=7585 Participants Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
Number of Participants With an Occurrence of Herpes Zoster Infection	46 Participants

SECONDARY outcome

Timeframe: From 6 weeks to 168 months (14 years) post vaccination

Herpes zoster cases were physician-diagnosed.

Outcome measures

Outcome measures
Measure	Varivax Vaccinated Children n=7585 Participants Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
Incidence Rate of Herpes Zoster Infection	0.45 Rate per 1000 person years Interval 0.33 to 0.6

Adverse Events

Varivax Vaccinated Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission, it being understood that the results of this study are not to be considered confidential. The sponsor review can be expedited to meet publication guidelines.
Publication restrictions are in place

Restriction type: OTHER