A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01077804
First received: February 26, 2010
Last updated: September 29, 2011
Last verified: September 2011
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Purpose
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.
| Condition |
|---|
|
Varicella Herpes Zoster |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Fifteen Year Follow-up to Evaluate Long-term Effectiveness of VARIVAX Among Children and Adolescents |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of Participants With an Occurrence of Breakthrough Varicella [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ] [ Designated as safety issue: No ]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.
- Incidence Rate of Breakthrough Varicella [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Number of Participants With an Occurrence of Herpes Zoster Infection [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ] [ Designated as safety issue: No ]Herpes zoster cases were physician-diagnosed cases.
- Incidence Rate of Herpes Zoster Infection [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ] [ Designated as safety issue: No ]Herpes zoster cases were physician-diagnosed.
| Enrollment: | 7585 |
| Study Start Date: | June 1995 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 12 Months to 23 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
15 years prospective follow-up of the original study cohort
Criteria
Inclusion Criteria:
- Subject was a member of Kaiser Permanente Northern California, age 12-23 months, received a dose of varicella vaccine between June and November 1995, and parents accepted to participate in 15-year follow-up
Exclusion Criteria:
- Subjects diagnosed with varicella before study enrollment
- Subject's parents unable to complete telephone interviews in English, Spanish, or Cantonese
Contacts and Locations More Information
Publications:
| 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 |
Additional relevant MeSH terms:
|
Chickenpox Herpes Zoster Herpesviridae Infections DNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 23, 2013