A Phase 2 interventional study of Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine) and GSK Biologicals' 208136, new formulation in Measles, Varicella and Mumps, sponsored by GlaxoSmithKline. Completed at 6 sites in 2 countries. Open to participants aged 11 Months to 21 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-15.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator.
A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's enrollment of 501 is below the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
Biological: GSK Biologicals' 208136, new formulation
Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Biological: Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine)
Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
Time frame: At 42-56 days after the first dose of study vaccine (Week 6)
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
Time frame: At 42-56 days after the second dose of study vaccine (Week 18)
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals.
Time frame: At 42-56 days after the first and second dose of study vaccine(s).
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.
Time frame: Within 4 days after each vaccination (Days 0-3)
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities.
Time frame: Within 43 days (Days 0-42) after each vaccination
Number of Subjects Reporting Any, Grade 3 and Related Fever
Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (\>) 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.
Time frame: Within 43 days (Days 0-42) after each vaccination
Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes
Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination.
Time frame: Within 43 days (Days 0-42) after each vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs)
An unsolicited 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 adverse event (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. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
Time frame: Within 43 days (Days 0-42) after first vaccination dose
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs)
An unsolicited 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 adverse event (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. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
Time frame: Within 43 days (Days 86-128) after second vaccination dose
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject.
Time frame: From first study dose (Day 0) until study end (Week 18)
| Milestone | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| Started | 332 | 166 |
| Completed | 327 | 165 |
| Not completed | 5 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Subject difficulties with blood drawing | 1 | 0 |
| Withdrew: Disclaimer/ withdrawal caused by h1n1 | 1 | 0 |
| Withdrew: Migrated/ moved from study area | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
| Participants | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| Anti-measles ≥ 150 mIU/mL | 312 | 157 |
| Anti-mumps ≥ 231 U/ML | 279 | 142 |
| Anti-rubella ≥ 4 IU/mL | 313 | 157 |
| IgG varicella antibodies ≥ 1:4 dilution | 284 | 131 |
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
| Participants | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| Anti-measles ≥ 150 mIU/mL | 308 | 156 |
| Anti-mumps ≥ 231 U/ML | 307 | 155 |
| Anti-rubella ≥ 4 IU/mL | 308 | 156 |
| IgG varicella antibodies ≥ 1:4 dilution | 286 | 138 |
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals.
| Titres | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| Anti-Measles (mIU/mL); Dose 1 | 3291.2 (3054 to 3546.8) | 3460.1 (3145.6 to 3806) |
| Anti-Mumps (U/mL); Dose 1 | 924.4 (821.9 to 1039.7) | 994.4 (851.7 to 1161) |
| Anti-Rubella (IU/mL); Dose 1 | 71.7 (66.1 to 77.9) | 66.6 (59.3 to 74.9) |
| Anti-Varicella (1/dil); Dose 1 | 104.8 (90.8 to 120.9) | 69.6 (53.6 to 90.2) |
| Anti-Measles (mIU/mL); Dose 2 | 4247.6 (3911.5 to 4612.6) | 4297.1 (3867.9 to 4774) |
| Anti-Mumps (U/mL); Dose 2 | 3379.5 (3121.3 to 3659) | 3216.2 (2870.9 to 3603) |
| Anti-Rubella (IU/mL); Dose 2 | 125.7 (117.4 to 134.5) | 115.2 (104.2 to 127.4) |
| Anti-Varicella (1/dil); Dose 2 | 6570.6 (5746.7 to 7512.7) | 5134.8 (4153.8 to 6347.4) |
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.
| Participants | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| Any Pain; Dose 1 | 62 | 28 |
| Grade 3 Pain; Dose 1 | 0 | 0 |
| Any Redness; Dose 1 | 92 | 44 |
| Grade 3 Redness; Dose 1 | 2 | 3 |
| Any Swelling; Dose 1 | 22 | 11 |
| Grade 3 Swelling; Dose 1 | 0 | 0 |
| Any Pain; Dose 2 | 46 | 24 |
| Grade 3 Pain; Dose 2 | 0 | 0 |
| Any Redness; Dose 2 | 79 | 43 |
| Grade 3 Redness; Dose 2 | 4 | 5 |
| Any Swelling; Dose 2 | 37 | 25 |
| Grade 3 Swelling; Dose 2 | 1 | 0 |
Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities.
| Participants | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| Any Meningism; Dose 1 | 2 | 1 |
| Grade 3 Meningism; Dose 1 | 0 | 0 |
| Any Parotid gland; Dose 1 | 0 | 0 |
| Grade 3 Parotid gland; Dose 1 | 0 | 0 |
| Any Meningism; Dose 2 | 2 | 0 |
| Grade 3 Meningism; Dose 2 | 1 | 0 |
| Any Parotid gland; Dose 2 | 0 | 0 |
| Grade 3 Parotid gland; Dose 2 | 0 | 0 |
Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (\>) 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.
| Participants | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| Any temperature; Dose 1 | 231 | 104 |
| Grade 3 temperature; Dose 1 | 54 | 23 |
| Related temperature; Dose 1 | 160 | 70 |
| Any temperature; Dose 2 | 115 | 62 |
| Grade 3 temperature; Dose 2 | 31 | 13 |
| Related temperature; Dose 2 | 29 | 28 |
Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination.
| Participants | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| Any, rash type; Dose 1 | 88 | 42 |
| Grade 3 rash type; Dose 1 | 9 | 6 |
| Related rash type; Dose 1 | 37 | 23 |
| Any, rash type; Dose 2 | 40 | 17 |
| Grade 3 rash type; Dose 2 | 6 | 1 |
| Related rash type; Dose 2 | 12 | 7 |
An unsolicited 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 adverse event (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. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
| Participants | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| Any AE(s) | 165 | 73 |
| Grade 3 AE(s) | 8 | 5 |
| Related AE(s) | 21 | 8 |
An unsolicited 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 adverse event (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. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
| Participants | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| Any AE(s) | 146 | 76 |
| Grade 3 AE(s) | 6 | 6 |
| Related AE(s) | 10 | 6 |
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject.
| Participants | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | 27 | 12 |
Collected over Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Priorix-Tetra New WS Group | 0/332 (0%) | 27/332 (8.1%) | 246/332 (74.1%) |
| Priorix-Tetra Current WS Group | 0/166 (0%) | 12/166 (7.2%) | 117/166 (70.5%) |
| Event | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| BronchiolitisInfections and infestations | 4/332 | 4/166 |
| Febrile convulsionNervous system disorders | 4/332 | 1/166 |
| Acute tonsillitisInfections and infestations | 4/332 | 0/166 |
| GastroenteritisInfections and infestations | 2/332 | 2/166 |
| Otitis media acuteInfections and infestations | 3/332 | 0/166 |
| Viral infectionInfections and infestations | 3/332 | 0/166 |
| Band neutrophil count increasedInvestigations | 0/332 | 1/166 |
| ConjunctivitisEye disorders | 0/332 | 1/166 |
| EnterocolitisGastrointestinal disorders | 2/332 | 1/166 |
| ConstipationGastrointestinal disorders | 0/332 | 1/166 |
| Event | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group |
|---|---|---|
| Fever; Dose 1Infections and infestations | 231/330 | 104/166 |
| Fever; Dose 2Infections and infestations | 115/327 | 62/164 |
| Redness; Dose 1General disorders | 92/330 | 44/166 |
| Rash; Dose 1Skin and subcutaneous tissue disorders | 88/330 | 42/166 |
| Redness; Dose 2General disorders | 79/327 | 43/164 |
| Pain; Dose 1General disorders | 62/330 | 28/166 |
| Upper respiratory tract infection; Dose 2Infections and infestations | 30/332 | 31/166 |
| Swelling; Dose 2General disorders | 37/327 | 25/164 |
| Upper respiratory tract infection; Dose 1Infections and infestations | 50/332 | 22/166 |
| Pain; Dose 2General disorders | 46/327 | 24/164 |
| Age, Continuous(Months) | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group | Total |
|---|---|---|---|
| Mean | 13 ± 1.94 | 12.9 ± 1.7 | 12.97 ± 1.86 |
| Sex: Female, Male(Participants) | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group | Total |
|---|---|---|---|
| Female | 166 | 84 | 250 |
| Male | 166 | 82 | 248 |
| Race/Ethnicity, Customized(Participants) | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group | Total |
|---|---|---|---|
| Asian - East Asian heritage | 165 | 83 | 248 |
| Asian - South East Asian heritage | 162 | 81 | 243 |
| White - Caucasian / European heritage | 3 | 1 | 4 |
| Unspecified | 2 | 1 | 3 |
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Jun 2009 to primary completion in Sep 2010, 15 months.
Results were first posted in Oct 2017, 7 years after primary completion. A results delay was requested in Jun 2011.
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