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CompletedNCT02062502Updated Oct 30, 2018Results posted

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

A Phase 3 interventional study of VARIVAX™ New Seed Process and VARIVAX™ 2007 process in Varicella, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 12 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-30.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
611
Allocation
Randomized
Ages
12 Months to 23 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Varicella

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03

In context

Chickenpox

152 studies on the registry are indexed under Chickenpox; 26 are open to participants now.

This study's enrollment of 611 is above the median of 478 across 126 interventional studies indexed under Chickenpox.

Browse Chickenpox studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 23 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
611 participants (actual)

Study arms

  • Experimental
    VARIVAX™ NSP + M-M-R II™

    VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91

    Biological: VARIVAX™ New Seed Process · Biological: M-M-R II™

  • Active comparator
    VARIVAX™ 2007 Process + M-M-R II™

    VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91

    Biological: VARIVAX™ 2007 process · Biological: M-M-R II™

Interventions

  • BiologicalVARIVAX™ New Seed Process

    Varicella virus vaccine live manufactured with a new seed process

  • BiologicalVARIVAX™ 2007 process

    Varicella virus vaccine live manufactured with the 2007 process

  • BiologicalM-M-R II™

    Measles, Mumps, and Rubella virus vaccine live

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL

    Time frame: 6 weeks (43 days) after vaccination 1

  2. Geometric Mean Titer of VZV Antibodies

    Antibody titers were measured with gpELISA.

    Time frame: 6 weeks (43 days) after vaccination 1

Secondary outcomes

  1. Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)

    Time frame: Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)

  2. Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1

    Time frame: Up to 42 days after Vaccination 1

  3. Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2

    Time frame: Up to 42 days after Vaccination 2

  4. Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1

    Time frame: Up to 5 days after Vaccination 1

  5. Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2

    Time frame: Up to 5 days after Vaccination 2

07

Results

Posted Mar 1, 2016

Participant flow

Participant flow — Overall Study
MilestoneVARIVAX™ New Seed Process + M-M-R II™VARIVAX™ 2007 Process + M-M-R II™
Started306305
Vaccinated dose 1306305
Completed263270
Not completed4335

Outcome measures

PrimaryPercentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Time frame:
6 weeks (43 days) after vaccination 1
Reported as:
Number · Percentage of participants
Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Percentage of participantsVARIVAX™ New Seed Process + M-M-R II™VARIVAX™ 2007 Process + M-M-R II™
Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL97.297.2
Statistical analysis
  • VARIVAX™ New Seed Process + M-M-R II™ vs VARIVAX™ 2007 Process + M-M-R II™ · Miettinen and Nurminen · p = <0.001 · Risk difference (rd): 0.0 · 95% CI -3.2 to 3.2
PrimaryGeometric Mean Titer of VZV Antibodies

Antibody titers were measured with gpELISA.

Time frame:
6 weeks (43 days) after vaccination 1
Reported as:
Geometric mean · gpELISA units/mL
Geometric Mean Titer of VZV Antibodies
gpELISA units/mLVARIVAX™ New Seed Process + M-M-R II™VARIVAX™ 2007 Process + M-M-R II™
Geometric Mean Titer of VZV Antibodies16.28 (15.11 to 17.55)17.2 (15.86 to 18.65)
Statistical analysis
  • VARIVAX™ New Seed Process + M-M-R II™ vs VARIVAX™ 2007 Process + M-M-R II™ · t-test, 2 sided · p = <0.001 · Risk difference (rd): 0.95 · 95% CI 0.85 to 1.06
  • VARIVAX™ New Seed Process + M-M-R II™ · Exact CI method/binomial proportion · p = <0.001 · Antibody response rate: 97.2 · 95% CI 94.4 to 98.9
SecondaryPercentage of Participants With Fever (>=102.2 °F Oral Equivalent)
Time frame:
Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)
Reported as:
Number · Percentage of participants
Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)
Percentage of participantsVARIVAX™ New Seed Process + M-M-R II™VARIVAX™ 2007 Process + M-M-R II™
Up to 42 days after Vaccination 1: n=285, 2879.510.5
Up to 42 days after Vaccination 2: n=258, 2678.18.6
SecondaryPercentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
Time frame:
Up to 42 days after Vaccination 1
Reported as:
Number · Percentage of participants
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
Percentage of participantsVARIVAX™ New Seed Process + M-M-R II™VARIVAX™ 2007 Process + M-M-R II™
Measles-like Rash0.32.4
Rubella-like Rash0.00.0
Varicella-like Rash0.00.3
Mumps-like Symptoms0.00.0
Injection-site Rash0.31.4
SecondaryPercentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
Time frame:
Up to 42 days after Vaccination 2
Reported as:
Number · Percentage of participants
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
Percentage of participantsVARIVAX™ New Seed Process + M-M-R II™VARIVAX™ 2007 Process + M-M-R II™
Measles-like Rash0.00.0
Rubella-like Rash0.00.0
Varicella-like Rash0.40.0
Mumps-like Symptoms0.00.0
Injection-site Rash0.70.0
SecondaryPercentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1
Time frame:
Up to 5 days after Vaccination 1
Reported as:
Number · Percentage of participants
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1
Percentage of participantsVARIVAX™ New Seed Process + M-M-R II™VARIVAX™ 2007 Process + M-M-R II™
Injection-site Erythema20.319.8
Injection-site Swelling10.010.6
Injection-site Pain/Tenderness29.928.0
SecondaryPercentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
Time frame:
Up to 5 days after Vaccination 2
Reported as:
Number · Percentage of participants
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
Percentage of participantsVARIVAX™ New Seed Process + M-M-R II™VARIVAX™ 2007 Process + M-M-R II™
Injection-site Erythema20.622.5
Injection-site Swelling16.212.0
Injection-site Pain/Tenderness22.424.3

Adverse events

Collected over SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
VARIVAX™ New Seed Process + M-M-R II™—6/291 (2.1%)225/291 (77.3%)
VARIVAX™ 2007 Process + M-M-R II™—9/293 (3.1%)224/293 (76.5%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventVARIVAX™ New Seed Process + M-M-R II™VARIVAX™ 2007 Process + M-M-R II™
BronchiolitisInfections and infestations0/2913/293
GastroenteritisInfections and infestations2/2910/293
Respiratory syncytial virus bronchiolitisInfections and infestations2/2911/293
Lobar pneumoniaInfections and infestations1/2910/293
PneumoniaInfections and infestations1/2910/293
DehydrationMetabolism and nutrition disorders1/2911/293
HypoglycaemiaMetabolism and nutrition disorders1/2910/293
Respiratory distressRespiratory, thoracic and mediastinal disorders1/2910/293
DrowningGeneral disorders0/2911/293
Groin abscessInfections and infestations0/2911/293
Most frequent other events
Showing 10 of 17
Most frequent other events
EventVARIVAX™ New Seed Process + M-M-R II™VARIVAX™ 2007 Process + M-M-R II™
Injection site painGeneral disorders106/291117/293
Injection site erythemaGeneral disorders95/29194/293
Injection site swellingGeneral disorders61/29159/293
PyrexiaGeneral disorders60/29160/293
Upper respiratory tract infectionInfections and infestations46/29144/293
DiarrhoeaGastrointestinal disorders37/29122/293
Otitis mediaInfections and infestations35/29133/293
RhinorrhoeaRespiratory, thoracic and mediastinal disorders31/29126/293
VomitingGastrointestinal disorders28/29118/293
Dermatitis diaperSkin and subcutaneous tissue disorders25/29127/293

Baseline characteristics

All randomized participants

Age, Continuous
Age, Continuous(Months)VARIVAX™ New Seed Process + M-M-R II™VARIVAX™ 2007 Process + M-M-R II™Total
Mean12.9 ± 1.912.8 ± 1.712.9 ± 1.8
Sex: Female, Male
Sex: Female, Male(Participants)VARIVAX™ New Seed Process + M-M-R II™VARIVAX™ 2007 Process + M-M-R II™Total
Female140139279
Male166166332
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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. PubMed 29087781 ↗

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02062502
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Feb 13, 2014
Start date
Mar 7, 2014
Primary completion
Feb 24, 2015
Completion
Oct 13, 2015
Results posted
Mar 1, 2016
Last update
Oct 30, 2018

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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