Herpes Zoster, Varicella
Conditions
Brief 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.
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.
Interventions
None listed
Sponsors
Kaiser Permanente
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Months to 23 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Occurrence of Breakthrough Varicella | 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. |
| Incidence Rate of Breakthrough Varicella | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Occurrence of Herpes Zoster Infection | From 6 weeks to 168 months (14 years) post vaccination | Herpes zoster cases were physician-diagnosed cases. |
| Incidence Rate of Herpes Zoster Infection | From 6 weeks to 168 months (14 years) post vaccination | Herpes zoster cases were physician-diagnosed. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7,585 |
| Total | 7,585 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 18 |
| Overall Study | Refused to continue | 79 |
| Overall Study | Unreachable | 102 |
Baseline characteristics
| Characteristic | Varivax Vaccinated Children |
|---|---|
| Age, Customized | 7585 Participants |
| Region of Enrollment United States | 7585 participants |
| Sex: Female, Male Female | 3714 Participants |
| Sex: Female, Male Male | 3871 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: From 6 weeks to 168 months (14 years) post vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varivax Vaccinated Children | Incidence Rate of Breakthrough Varicella | Any varicella | 15.9 Rate per 1000 person years |
| Varivax Vaccinated Children | Incidence Rate of Breakthrough Varicella | Varicella with > 50 lesions | 4 Rate per 1000 person years |
| Varivax Vaccinated Children | Incidence Rate of Breakthrough Varicella | Varicella with > 300 lesions | 0.3 Rate per 1000 person years |
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.
Time frame: From 6 weeks to 168 months (14 years) post vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varivax Vaccinated Children | Number of Participants With an Occurrence of Breakthrough Varicella | Any Varicella symptoms | 1425 Participants |
| Varivax Vaccinated Children | Number of Participants With an Occurrence of Breakthrough Varicella | Varicella with >300 lesions | 28 Participants |
| Varivax Vaccinated Children | Number of Participants With an Occurrence of Breakthrough Varicella | Varicella with >50 lesions | 362 Participants |
Secondary
Incidence Rate of Herpes Zoster Infection
Herpes zoster cases were physician-diagnosed.
Time frame: From 6 weeks to 168 months (14 years) post vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varivax Vaccinated Children | Incidence Rate of Herpes Zoster Infection | 0.45 Rate per 1000 person years |
Secondary
Number of Participants With an Occurrence of Herpes Zoster Infection
Herpes zoster cases were physician-diagnosed cases.
Time frame: From 6 weeks to 168 months (14 years) post vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varivax Vaccinated Children | Number of Participants With an Occurrence of Herpes Zoster Infection | 46 Participants |