Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)

Varicella Clinical Trial

Official title:

A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ New Seed Process (NSP) Administered Concomitantly With M-M-R™ II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062502
• Other study ID #: V210-063
• Status: Completed
• Phase: Phase 3
• Start date: March 7, 2014
• Est. completion date: October 13, 2015

Study information

• Verified date: October 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: October 13, 2015
• Est. primary completion date: February 24, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 23 Months

Eligibility

Inclusion Criteria:

• Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella

Exclusion Criteria:

• Received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study

• Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity

• Received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to receive them during the course of the study

• History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX™ or M-M-R II™

• Received salicylates within 14 days prior to study vaccination

• Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination

• Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination

• History of seizure disorder, including febrile seizure

• Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination

• History of thrombocytopenia

• Born to a human immunodeficiency virus (HIV)-infected mother

• Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.

Related Conditions & MeSH terms

• Varicella

Intervention

Biological:
• VARIVAX™ New Seed Process
Varicella virus vaccine live manufactured with a new seed process
• VARIVAX™ 2007 process
Varicella virus vaccine live manufactured with the 2007 process
• M-M-R II™
Measles, Mumps, and Rubella virus vaccine live

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Senders SD, Bundick ND, Li J, Zecca C, Helmond FA. Evaluation of immunogenicity and safety of VARIVAX™ New Seed Process (NSP) in children. Hum Vaccin Immunother. 2018 Feb 1;14(2):442-449. doi: 10.1080/21645515.2017.1388479. Epub 2017 Dec 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL		6 weeks (43 days) after vaccination 1
Primary	Geometric Mean Titer of VZV Antibodies	Antibody titers were measured with gpELISA.	6 weeks (43 days) after vaccination 1
Secondary	Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)		Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)
Secondary	Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1		Up to 42 days after Vaccination 1
Secondary	Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2		Up to 42 days after Vaccination 2
Secondary	Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1		Up to 5 days after Vaccination 1
Secondary	Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2		Up to 5 days after Vaccination 2