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VaricellaPhase 3NCT00969436

Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM

A Phase 3 study testing GSK Biological's investigational MMRV vaccine 208136, Priorix™ and Varilrix™ in people with Varicella and Rubella, run by GlaxoSmithKline at 6 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™ administered at 9 months of age followed by… Read more about this study

Who is it for?
Ages 9 to 10 monthsHealthy volunteers can take part
Conditions the study is for
Varicella, Rubella, Mumps
What is being tested?
GSK Biological's investigational MMRV vaccine 208136, Priorix™ and Varilrix™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
6 sitesIndia
Study dates
9 Nov 2009to 21 Feb 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 10 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • Male or female subjects between and including 9 and 10 months of age at the time of the first vaccination.
  • Written informed consent obtained from the the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Who cannot join

  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days prior to administration of any dose of the study vaccine, up to 42 days after the vaccine dose with the exception of hepatitis A vaccine and oral poliovirus vaccine .
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-registered product.
  • Previous vaccination against measles, mumps, rubella and varicella.
  • History of measles, mumps, rubella and/or varicella diseases.
Show all 16Show fewer
  • Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines including neomycin.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  • Axillary temperature > 37.5°C (99.5°F) / Rectal temperature > 38°C (100.4°F).
  • Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
  • Presence of a susceptible high-risk person in the same household during the study period.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

India6 sites

  • GSK Investigational Site

    Bangalore, 560034

  • GSK Investigational Site

    Chennai

  • GSK Investigational Site

    Goa, 403202

  • GSK Investigational Site

    Kolkata, 700073

  • GSK Investigational Site

    Pune, 411 011

  • GSK Investigational Site

    Pune

Other trials in India

About this study

Official title: A Phase IIIb, Open, Randomised, Multicentre, Primary Study in Healthy Children, to Establish the Non-inferiority of GlaxoSmithKline (GSK) Biologicals' MeMuRu-OKA Vaccine (Administered at 9 and 15 Months of Age) Versus Priorix™ (9 Months of Age) and Priorix™ Co-administered With Varilrix™ at 15 Months of Age (Comparator) and Also to Evaluate the Non-inferiority of Priorix™ (9 Months of Age) and MeMuRu-OKA Vaccine (15 Months of Age) Versus the Comparator, All Administered Subcutaneously as Two-dose Primary Vaccination Course

The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™ administered at 9 months of age followed by concomitant administration of Priorix™ with Varilrix™ at 15 months of age in a measles endemic environment such as India.

Being tested
GSK Biological's investigational MMRV vaccine 208136, Priorix™, Varilrix™
Keywords
Mumps, Immunogenicity, Vaccines, Safety, Rubella, Combined Vaccine, Varicella Vaccine, Children, Measles, Humans
Medical subject headings
Chickenpox, Rubella, Mumps, Measles

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK Biological's investigational MMRV vaccine 208136Biological

    Subcutaneous injection

  • Priorix™Biological

    Subcutaneous injection

  • Varilrix™Biological

    Subcutaneous injection

Study groups in NCT00969436
Study groupRoleWhat they receive
Priorix-Tetra GroupExperimentalSubjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
Receives: Biological: GSK Biological's investigational MMRV vaccine 208136
Priorix/ Priorix-Tetra GroupExperimentalSubjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
Receives: Biological: GSK Biological's investigational MMRV vaccine 208136; Biological: Priorix™
Control GroupActive comparatorSubjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Receives: Biological: Priorix™; Biological: Varilrix™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies

    Seroconversion was defined as the appearance of antibodies [i.e. concentration/titre greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.

    Measured: At 42 - 56 days after the second vaccination dose at week 30

Secondary outcomes (8)

  1. Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies

    Seroconversion was defined as the appearance of antibodies (i.e. concentration/titre ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and for IgG varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.

    Measured: Approximately 42 to 56 days after the first vaccine dose at week 6

  2. Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses

    Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs).

    Measured: At 42 - 56 days after the first (at Week 6) and second (at Week 30) vaccination dose

  3. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

    Measured: During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2)

  4. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

    Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related = symptom assessed by the investigator as related to the vaccination.

    Measured: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)

  5. Number of Subjects Reporting Any, Grade 3 and Related Fever

    Any fever was defined as fever ≥ 38.0°C and grade 3 fever was defined as fever > 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.

    Measured: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)

  6. Number of Subjects Reporting Any, Grade 3 and Related Rash

    Any rash was defined as incidence of a rash regardless of intensity grade or relationship to vaccination and grade 3 rash greater than (>) 150 lesions. Related rash was defined as rash assessed by the investigator as causally related to the vaccination

    Measured: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)

  7. Number of Subjects Reporting Any Unsolicited Adverse Event

    An unsolicited Adverse Event (AE) covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

    Measured: Within 43-day (Days 0-42) after the first and second vaccination dose

  8. Number of Subjects With Serious Adverse Events (SAEs)

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.

    Measured: From the first study dose up to study end (Month 0 to Month 7.5 approximately)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2009 (estimated)
  2. Study start9 Nov 2009
  3. Primary completion21 Feb 2011
  4. Study completion21 Feb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00969436
Sponsor's protocol ID
109995
Status last verified
May 2017
First submitted
20 Aug 2009
Last updated
8 Jun 2018
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Lalwani S, Chatterjee S, Balasubramanian S, Bavdekar A, Mehta S, Datta S, Povey M, Henry O. Immunogenicity and safety of early vaccination with two doses of a combined measles-mumps-rubella-varicella vaccine in healthy Indian children from 9 months of age: a phase III, randomised, non-inferiority trial. BMJ Open. 2015 Sep 11;5(9):e007202. doi: 10.1136/bmjopen-2014-007202.

    PubMed 26362659

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK Biological's investigational MMRV vaccine 208136, Priorix™ and Varilrix™ in people with Varicella and Rubella, run by GlaxoSmithKline at 6 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies (time frame: At 42 - 56 days after the second vaccination dose at week 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00969436, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.

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