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

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Conditions:	Varicella Herpes Zoster

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Varivax Vaccinated Children
STARTED	7585
COMPLETED	7386
NOT COMPLETED	199
Unreachable	102
Refused to continue	79
Other	18

Baseline Characteristics

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Reporting Groups

	Description
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.

Baseline Measures

	Varivax Vaccinated Children
Number of Participants [units: participants]	7585
Age, Customized [units: Participants]
12-23 months	7585
Gender [units: participants]
Female	3714
Male	3871
Region of Enrollment [units: participants]
United States	7585

Outcome Measures

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1. Primary:

Number of Participants With an Occurrence of Breakthrough Varicella [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ]

Measure Type	Primary
Measure Title	Number of Participants With an Occurrence of Breakthrough Varicella
Measure Description	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.
Time Frame	From 6 weeks to 168 months (14 years) post vaccination
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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.

Measured Values

	Varivax Vaccinated Children
Number of Participants Analyzed [units: participants]	7585
Number of Participants With an Occurrence of Breakthrough Varicella [units: Participants]
Any Varicella symptoms	1425
Varicella with >50 lesions	362
Varicella with >300 lesions	28

No statistical analysis provided for Number of Participants With an Occurrence of Breakthrough Varicella

2. Primary:

Incidence Rate of Breakthrough Varicella [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ]

Measure Type	Primary
Measure Title	Incidence Rate of Breakthrough Varicella
Measure Description	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.
Time Frame	From 6 weeks to 168 months (14 years) post vaccination
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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.

Measured Values

	Varivax Vaccinated Children
Number of Participants Analyzed [units: participants]	7585
Incidence Rate of Breakthrough Varicella [units: Rate per 1000 person years] Number ( 95% Confidence Interval )
Any varicella	15.9 ( 15.1 to 16.7 )
Varicella with > 50 lesions	4 ( 3.6 to 4.9 )
Varicella with > 300 lesions	0.3 ( 0.2 to 0.5 )

No statistical analysis provided for Incidence Rate of Breakthrough Varicella

3. Secondary:

Number of Participants With an Occurrence of Herpes Zoster Infection [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ]

Measure Type	Secondary
Measure Title	Number of Participants With an Occurrence of Herpes Zoster Infection
Measure Description	Herpes zoster cases were physician-diagnosed cases.
Time Frame	From 6 weeks to 168 months (14 years) post vaccination
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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.

Measured Values

	Varivax Vaccinated Children
Number of Participants Analyzed [units: participants]	7585
Number of Participants With an Occurrence of Herpes Zoster Infection [units: Participants]	46

No statistical analysis provided for Number of Participants With an Occurrence of Herpes Zoster Infection

4. Secondary:

Incidence Rate of Herpes Zoster Infection [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ]

Measure Type	Secondary
Measure Title	Incidence Rate of Herpes Zoster Infection
Measure Description	Herpes zoster cases were physician-diagnosed.
Time Frame	From 6 weeks to 168 months (14 years) post vaccination
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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.

Measured Values

	Varivax Vaccinated Children
Number of Participants Analyzed [units: participants]	7585
Incidence Rate of Herpes Zoster Infection [units: Rate per 1000 person years] Number ( 95% Confidence Interval )	0.45 ( 0.33 to 0.60 )

No statistical analysis provided for Incidence Rate of Herpes Zoster Infection

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

Publications:

Guess HA, Broughton DD, Melton LJ 3rd, Kurland LT. Population-based studies of varicella complications. Pediatrics. 1986 Oct;78(4 Pt 2):723-7.

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01077804 History of Changes
Other Study ID Numbers:	V210-036, 2010_014
Study First Received:	February 26, 2010
Results First Received:	September 29, 2011
Last Updated:	September 29, 2011
Health Authority:	United States: Institutional Review Board