Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01077804
Other study ID # V210-036
Secondary ID 2010_014EP08005.
Status Completed
Phase N/A
First received February 26, 2010
Last updated October 22, 2015
Start date June 1995
Est. completion date November 2010

Study information

Verified date October 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 7585
Est. completion date November 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Months to 23 Months
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp. Kaiser Permanente

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
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. From 6 weeks to 168 months (14 years) post vaccination No
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. From 6 weeks to 168 months (14 years) post vaccination No
Secondary 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 No
Secondary Incidence Rate of Herpes Zoster Infection Herpes zoster cases were physician-diagnosed. From 6 weeks to 168 months (14 years) post vaccination No
See also
  Status Clinical Trial Phase
Completed NCT03120364 - Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over Phase 3
Completed NCT01165203 - Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects Phase 2
Recruiting NCT06088745 - A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine Phase 3
Completed NCT01385566 - A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2) Phase 1
Completed NCT01911065 - T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020 Phase 4
Completed NCT01137669 - ZOSTAVAX® in Renal Transplant Patients Phase 1
Completed NCT00550745 - ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020) Phase 4
Completed NCT01132729 - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions N/A
Completed NCT01132716 - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions N/A
Completed NCT02852876 - Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food Phase 1
Completed NCT00231816 - A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011) Phase 3
Completed NCT05082688 - Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX) Phase 2
Completed NCT04099706 - Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT N/A
Active, not recruiting NCT04091451 - A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles Phase 3
Completed NCT02519855 - Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062) Phase 3
Completed NCT04523246 - Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents Early Phase 1
Completed NCT05047770 - A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine Phase 3
Completed NCT03314103 - Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age Phase 3
Completed NCT01527370 - Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025) Phase 3
Completed NCT01954251 - Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older Phase 3