NCT01077804

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

Completed Results posted Last updated 15 September 2017

What this trial tests

trial in Varicella in 7,585 participants. Completed in 1 November 2010.

Timeline

1 June 1995

Primary endpoint
1 September 2010

1 November 2010

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Status	Completed
Study type	OBSERVATIONAL
Enrollment	7,585
Start date	1 June 1995
Primary completion	1 September 2010
Estimated completion	1 November 2010

Conditions studied

• Varicella — all drugs for Varicella →
• Herpes Zoster — all drugs for Herpes Zoster →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 12 Months to 23 Months, any sex, with Varicella or Herpes Zoster. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With an Occurrence of Herpes Zoster Infection Secondary · From 6 weeks to 168 months (14 years) post vaccination

Herpes zoster cases were physician-diagnosed cases.

Group	Value	95% CI
Varivax Vaccinated Children	46

Number of Participants With an Occurrence of Breakthrough Varicella Primary · 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.

Any Varicella symptoms

Group	Value	95% CI
Varivax Vaccinated Children	1425

Varicella with >50 lesions

Group	Value	95% CI
Varivax Vaccinated Children	362

Varicella with >300 lesions

Group	Value	95% CI
Varivax Vaccinated Children	28

Incidence Rate of Breakthrough Varicella Primary · 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.

Any varicella

Group	Value	95% CI
Varivax Vaccinated Children	15.9	15.1 – 16.7

Varicella with > 50 lesions

Group	Value	95% CI
Varivax Vaccinated Children	4	3.6 – 4.9

Varicella with > 300 lesions

Group	Value	95% CI
Varivax Vaccinated Children	0.3	0.2 – 0.5

Incidence Rate of Herpes Zoster Infection Secondary · From 6 weeks to 168 months (14 years) post vaccination

Herpes zoster cases were physician-diagnosed.

Group	Value	95% CI
Varivax Vaccinated Children	0.45	0.33 – 0.60

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.