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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_014 | Other Identifier | Merck | |
| EP08005.002 | Other Identifier | Merck |
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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
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The purpose of these continuing post-licensure studies is to evaluate the long-term effectiveness of VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)] and to assess the impact of the vaccine on the epidemiology of varicella and herpes zoster.
Parents/guardians of the cohort of children vaccinated between 12 and 23 months of age during a six-month period in 1995 (June-November) at KPMCP Northern California were interviewed by telephone at 6-month intervals to ascertain whether their child had varicella or herpes zoster in the 6 months prior to interview. Follow-up continued for a minimum of 14 years after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varivax vaccinated children | Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Occurrence of Breakthrough Varicella | 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. | From 6 weeks to 168 months (14 years) post vaccination |
| Incidence Rate of Breakthrough Varicella | 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. | From 6 weeks to 168 months (14 years) post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Occurrence of Herpes Zoster Infection | Herpes zoster cases were physician-diagnosed cases. | From 6 weeks to 168 months (14 years) post vaccination |
| Incidence Rate of Herpes Zoster Infection |
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Inclusion Criteria:
Exclusion Criteria:
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15 years prospective follow-up of the original study cohort
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| Name | Affiliation | Role |
|---|---|---|
| Roger Baxter | Kaiser Permanente | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23545380 | Result | Baxter R, Ray P, Tran TN, Black S, Shinefield HR, Coplan PM, Lewis E, Fireman B, Saddier P. Long-term effectiveness of varicella vaccine: a 14-Year, prospective cohort study. Pediatrics. 2013 May;131(5):e1389-96. doi: 10.1542/peds.2012-3303. Epub 2013 Apr 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With an Occurrence of Herpes Zoster Infection | Herpes zoster cases were physician-diagnosed cases. | Posted | Number | Participants | From 6 weeks to 168 months (14 years) post vaccination |
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The purpose of this study was to monitor changes in vaccine effectiveness over time and no collection of adverse events was required. Therefore, no data on adverse events were collected and the number at risk is zero.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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Herpes zoster cases were physician-diagnosed.
| From 6 weeks to 168 months (14 years) post vaccination |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Participants With an Occurrence of Breakthrough Varicella | 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. | Posted | Number | Participants | From 6 weeks to 168 months (14 years) post vaccination |
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|
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| Primary | Incidence Rate of Breakthrough Varicella | 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. | Posted | Number | 95% Confidence Interval | Rate per 1000 person years | From 6 weeks to 168 months (14 years) post vaccination |
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| Secondary | Incidence Rate of Herpes Zoster Infection | Herpes zoster cases were physician-diagnosed. | Posted | Number | 95% Confidence Interval | Rate per 1000 person years | From 6 weeks to 168 months (14 years) post vaccination |
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| 0 |
| 0 |
| 0 |
| 0 |
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.
| D007239 | Infections |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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