Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)

January 12, 2021 updated by: Merck Sharp & Dohme LLC

A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34) Process Administered Concomitantly With M-M-R™ II

This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with the VARIVAX® 2016 commercial 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® PE34 Process are non-inferior to those induced by VARIVAX® 2016 commercial process, and that antibody response rate induced by VARIVAX® PE34 Process is acceptable.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Alabama Clinical Therapeutics ( Site 0018)
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Children's Clinic of Jonesboro, PA ( Site 0030)
    • California
      • Anaheim, California, United States, 92804
        • Southland Clinical Research Center ( Site 0017)
      • Downey, California, United States, 90240
        • Premier Health Research Center, LLC ( Site 0044)
      • San Diego, California, United States, 92123
        • California Research Foundation ( Site 0003)
    • Colorado
      • Thornton, Colorado, United States, 80233
        • IMMUNOe Research Centers ( Site 0046)
    • Florida
      • Lake Mary, Florida, United States, 32746
        • Children's Research at Altamonte Pediatric Associates ( Site 0040)
      • Tampa, Florida, United States, 33606
        • University of South Florida ( Site 0042)
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research ( Site 0038)
    • Kansas
      • Augusta, Kansas, United States, 67010
        • Heartland Research Associates, LLC ( Site 0029)
      • Newton, Kansas, United States, 67114
        • Heartland Research Associates, LLC ( Site 0015)
      • Topeka, Kansas, United States, 66604
        • Cotton O'Neil Research Center ( Site 0014)
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric/Adult Research Inc ( Site 0012)
      • Louisville, Kentucky, United States, 40202
        • University of Louisville: Pediatric Clinical Trials Unit ( Site 0025)
    • Louisiana
      • Haughton, Louisiana, United States, 71037
        • ACC Pediatric Research ( Site 0041)
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center For Pharmaceutical Research PC ( Site 0011)
    • New York
      • East Syracuse, New York, United States, 13057
        • Child Health Care Associates ( Site 0045)
    • North Carolina
      • Boone, North Carolina, United States, 28607
        • Blue Ridge Pediatric & Adolescent Medicine ( Site 0001)
      • Winston-Salem, North Carolina, United States, 27103
        • Ford, Simpson, Lively & Rice Pediatrics, PLLC ( Site 0037)
    • Ohio
      • Cleveland, Ohio, United States, 44121
        • Senders Pediatrics ( Site 0034)
      • Dayton, Ohio, United States, 45414
        • Ohio Pediatric Research Association ( Site 0035)
    • Pennsylvania
      • Hermitage, Pennsylvania, United States, 16148
        • Kid's Way Pediatrics ( Site 0047)
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Coastal Pediatric Research ( Site 0006)
      • Charleston, South Carolina, United States, 29406
        • Palmetto Pediatrics, PA ( Site 0023)
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group Pediatrics ( Site 0024)
    • Texas
      • Austin, Texas, United States, 78705
        • Benchmark Research ( Site 0005)
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch at Galveston ( Site 0032)
      • Houston, Texas, United States, 77055
        • West Houston Clinical Research Services ( Site 0009)
      • Tomball, Texas, United States, 77375
        • Pediatric Healthcare of Northwest Houston ( Site 0027)
    • Utah
      • Layton, Utah, United States, 84041
        • Tanner Clinic ( Site 0010)
      • Roy, Utah, United States, 84067
        • Wee Care Pediatrics-Roy ( Site 0043)
      • Salt Lake City, Utah, United States, 84109
        • J Lewis Research Inc / Foothill Family Clinic ( Site 0016)
      • Salt Lake City, Utah, United States, 84121
        • J Lewis Research Inc/Foothill Family Clinic South ( Site 0004)
      • South Jordan, Utah, United States, 84095
        • J Lewis Research Inc/Jordan River Family Medicine ( Site 0019)
      • Syracuse, Utah, United States, 84075
        • Wee Care Pediatrics ( Site 0036)
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research ( Site 0020)
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Pediatric Research of Charlottesville, LLC ( Site 0039)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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®
  • Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic systems
  • 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
  • Has a diagnosis of active untreated tuberculosis
  • Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®
VARIVAX® Passage Extension (PE34) Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91
Biological: VARIVAX® PE34 Process
Varicella virus vaccine live manufactured with a new passage extension process (PE34)
Biological: M-M-R II®
Measles, Mumps, and Rubella virus vaccine live
Active Comparator: VARIVAX® 2016 Commercial Process + M-M-R II®
VARIVAX® 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91
Biological: M-M-R II®
Measles, Mumps, and Rubella virus vaccine live
Biological: VARIVAX® 2016 Commercial Process
Varicella virus vaccine live manufactured with the 2016 commercial process

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Time Frame: 6 weeks (43 days) after vaccination 1
The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers <1.25 gpELISA units/mL) at baseline.
6 weeks (43 days) after vaccination 1
Geometric Mean Titer of VZV Antibodies
Time Frame: 6 weeks (43 days) after vaccination 1
The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA.
6 weeks (43 days) after vaccination 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)
Time Frame: Up to 42 days after vaccination 1; Up to 42 days after vaccination 2
The percentage of participants with fever ≥102.2 °F oral equivalent for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Up to 42 days after vaccination 1; Up to 42 days after vaccination 2
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%)
Time Frame: Up to 42 days after vaccination 1
The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Up to 42 days after vaccination 1
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%)
Time Frame: Up to 42 days after vaccination 2
The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Up to 42 days after vaccination 2
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1
Time Frame: Up to 5 days after vaccination 1
The percentage of participants with solicited (on a Vaccine Report Card) injection-site erythema, injection-site swelling, or injection-site pain/tenderness was assessed.
Up to 5 days after vaccination 1
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
The percentage of participants with solicited (Vaccine Report Card) injection-site erythema, injection-site swelling, and injection-site pain/tenderness was assessed.
Up to 5 days after vaccination 2
Percentage of Participants With One or More Adverse Events
Time Frame: Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
Percentage of Participants With One or More Serious Adverse Events
Time Frame: Up to ~180 days after vaccination 2 (Up to ~285 days)
A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAEs ~180 days after vaccination 2 was reported.
Up to ~180 days after vaccination 2 (Up to ~285 days)
Percentage of Participants With One or More Vaccine-Related Adverse Events
Time Frame: Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
The percentage of participants with one or more vaccine-related adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4)
Time Frame: Up to 42 days after vaccination 1
All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 1. The percentage of participants with one or more systemic adverse events (incidence ≥4 participants in one or more of the vaccination groups) was reported.
Up to 42 days after vaccination 1
Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence > 0)
Time Frame: Up to 42 days after vaccination 2
All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 2. The percentage of participants with one or more systemic adverse events was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Up to 42 days after vaccination 2
Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL)
Time Frame: 6 weeks (~43 days) after vaccination 1
The percentage of participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and postvaccination serology contributing to the per-protocol analysis was assessed. Confidence interval is calculated if there are at least 5 subjects who are seropositive. Antibody titers were assessed using gpELISA.
6 weeks (~43 days) after vaccination 1
Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody
Time Frame: Baseline and 6 weeks (~43 days) after vaccination 1
Blood samples were taken at pre-vaccination (baseline) and approximately 43 days after vaccination 1 to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The geometric mean fold rise (GMFR) was calculated as GMT post vaccination 1/GMT pre-vaccination (baseline). Confidence interval is calculated if there are at least 5 subjects who are seropositive.
Baseline and 6 weeks (~43 days) after vaccination 1
Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody
Time Frame: Baseline and 6 weeks (~43 days) after vaccination 1
The percentage of participants with a geometric mean ≥4-fold rise from baseline of ≥1.25gpELISA units/mL in VZV antibody titer at approximately 43 days after vaccination 1 was assessed.
Baseline and 6 weeks (~43 days) after vaccination 1
Percentage of Participants With One or More Vaccine-Related Serious Adverse Events
Time Frame: Up to ~180 days after vaccination 2
The percentage of participants with one or more vaccine-related serious adverse events up to ~180 days after vaccination 2 was reported. The study investigator determines whether the serious adverse event is related to the vaccine.
Up to ~180 days after vaccination 2
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
Time Frame: Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
The percentage of participants discontinued from the study due to an adverse event for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence > 0%)
Time Frame: Up to 42 days after vaccination 1
The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Up to 42 days after vaccination 1
Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence > 0%)
Time Frame: Up to 42 days after vaccination 2
The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
Up to 42 days after vaccination 2
Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%)
Time Frame: Up to ~180 days after vaccination 2 (Up to ~285 days)
The percentage of participants with medically-attended AEs up to ~180 days after vaccination 2 that did not meet the definition of serious adverse event (incidence ≥5% in one or more vaccination groups) was reported.
Up to ~180 days after vaccination 2 (Up to ~285 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V210-A03 (Other Identifier: Merck)
  • 2017-001910-27 (Other Identifier: EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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