A Phase 2 interventional study of Priorix-Tetra™ (MMRV vaccine 208136) and ProQuad® in Varicella, Rubella and Mumps, sponsored by GlaxoSmithKline. Completed at 141 sites in United States. Open to participants aged 12 Months to 14 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
The purpose of this observer blinded study is to provide information on vaccine immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when administered with Hepatitis A vaccine and Pneumococcal vaccine.
180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.
This study's enrollment of 1,851 is above the median of 475 across 149 interventional studies indexed under Chickenpox.
Browse Chickenpox 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:
Residence in the same household as the following persons:
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.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects received refrigerator-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation A) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180
Biological: Priorix-Tetra™ (MMRV vaccine 208136) · Biological: Havrix® · Biological: Prevnar®
Subjects received freezer-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation B) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180
Biological: Priorix-Tetra™ (MMRV vaccine 208136) · Biological: Havrix® · Biological: Prevnar®
Subjects received ProQuad® co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180
Biological: ProQuad® · Biological: Havrix® · Biological: Prevnar®
Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)
Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies \[concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.
Time frame: At Day 42 after vaccination
Concentration of Antibodies to Varicella Virus (VZV)
Concentrations are given as Geometric Mean Concentrations (GMCs).
Time frame: At Day 42 after vaccination
Number of Subjects With Seroresponse for Antibodies to Mumps Virus
Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies \[titer greater than or equal to the threshold of 51 Effective Doses (ED50)\] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.
Time frame: At Day 42 after vaccination
Number of Subjects With Seroresponse for Antibodies to Measles Virus
Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies \[concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.
Time frame: At Day 42 after vaccination
Number of Subjects With Seroresponse for Antibodies to Rubella Virus
Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies \[concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)\] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.
Time frame: At Day 42 after vaccination
Concentration of Antibodies to Hepatitis A Virus (HAV)
Concentrations are given as Geometric Mean Concentrations (GMCs).
Time frame: At Day 42 after vaccination
Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Concentrations are given as Geometric Mean Concentrations (GMCs).
Time frame: At Day 42 after vaccination
Antibody Titers to Mumps Virus
Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.
Time frame: At Day 42 after vaccination
Concentration of Antibodies to Measles Virus
Concentrations are given as Geometric Mean Concentrations (GMCs).
Time frame: At Day 42 after vaccination
Concentration of Antibodies to Rubella Virus
Concentrations are given as Geometric Mean Concentrations (GMCs).
Time frame: At Day 42 after vaccination
Number of Subjects With Vaccine Response to Havrix
Vaccine response to Havrix is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies \[concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)\] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.
Time frame: At Day 42 after vaccination
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).
Time frame: At Day 42 after vaccination
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).
Time frame: At Day 42 after vaccination
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).
Time frame: At Day 42 after vaccination
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).
Time frame: At Day 42 after vaccination
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Time frame: During the 4 day follow up period following vaccination
Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination
Fever was measured rectally.
Time frame: During the 15-day follow-up period following vaccination
Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination
Fever was measured rectally.
Time frame: During the 43-day follow-up period following vaccination
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash
Time frame: During the 43-day follow-up period after vaccination
Number of Subjects Reporting Investigator-confirmed Varicella-like Rash
Time frame: During the 43-day follow-up period after vaccination
Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling
Time frame: During the 43-day follow-up period after vaccination
Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)
Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel.
Time frame: During the 43-day follow-up period after vaccination
Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits
New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.
Time frame: For approximately 6 months (Day 0-180)
Number of Subjects Reporting Serious Adverse Events
Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: For approximately 6 months (Day 0-180)
| Milestone | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group |
|---|---|---|---|
| Started | 705 | 689 | 389 |
| Completed | 635 | 646 | 365 |
| Not completed | 70 | 43 | 24 |
| Withdrew: Adverse event | 0 | 1 | 1 |
| Withdrew: Other reasons | 70 | 42 | 23 |
Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies \[concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group |
|---|---|---|---|
| Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV) | 355 | 440 | 301 |
Concentrations are given as Geometric Mean Concentrations (GMCs).
| milli-international units per milliliter | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group |
|---|---|---|---|
| Concentration of Antibodies to Varicella Virus (VZV) | 83.6 (77.0 to 90.8) | 109.9 (102.1 to 118.3) | 164.3 (152.3 to 177.3) |
Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies \[titer greater than or equal to the threshold of 51 Effective Doses (ED50)\] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group |
|---|---|---|---|
| Number of Subjects With Seroresponse for Antibodies to Mumps Virus | 491 | 498 | 256 |
Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies \[concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group |
|---|---|---|---|
| Number of Subjects With Seroresponse for Antibodies to Measles Virus | 616 | 633 | 342 |
Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies \[concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)\] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group |
|---|---|---|---|
| Number of Subjects With Seroresponse for Antibodies to Rubella Virus | 616 | 622 | 349 |
Concentrations are given as Geometric Mean Concentrations (GMCs).
| milli-international units per milliliter | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group |
|---|---|---|---|
| Concentration of Antibodies to Hepatitis A Virus (HAV) | 40.5 (37.1 to 44.2) | 40.3 (37.0 to 44.0) | 40.0 (35.7 to 44.9) |
Concentrations are given as Geometric Mean Concentrations (GMCs).
| micrograms per milliliter (µg/mL) | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group |
|---|---|---|---|
| S.Pneu.4 (n= 461, 463, 266) | 3.35 (3.10 to 3.63) | 3.31 (3.04 to 3.59) | 3.02 (2.72 to 3.34) |
| S.Pneu.6B (n= 460, 464, 265) | 5.65 (5.16 to 6.19) | 5.91 (5.40 to 6.45) | 5.43 (4.90 to 6.02) |
| S.Pneu.9V (n=461, 468, 266) | 5.81 (5.37 to 6.29) | 5.66 (5.23 to 6.13) | 5.54 (5.02 to 6.12) |
| S.Pneu.14 (n= 460, 465, 266) | 9.71 (8.99 to 10.50) | 9.54 (8.81 to 10.34) | 8.96 (8.07 to 9.95) |
| S.Pneu.18C (n= 458, 465, 263) | 5.50 (5.04 to 6.01) | 5.80 (5.30 to 6.34) | 5.51 (4.95 to 6.12) |
| S.Pneu.19F (n= 454, 460, 261) | 2.52 (2.32 to 2.74) | 2.52 (2.32 to 2.73) | 2.31 (2.06 to 2.59) |
| S.Pneu.23F (n= 459, 464, 266) | 10.10 (9.22 to 11.06) | 10.85 (9.87 to 11.91) | 9.79 (8.65 to 11.07) |
Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.
| titer | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Antibody Titers to Mumps Virus | 222.4 (202.5 to 244.3) | 224.6 (206.9 to 243.9) | 253.1 (222.7 to 287.7) |
Concentrations are given as Geometric Mean Concentrations (GMCs).
| milli-international units per milliliter | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Concentration of Antibodies to Measles Virus | 4723.1 (4436.4 to 5028.4) | 4650.3 (4430.9 to 4880.5) | 4207.1 (3823.3 to 4629.3) |
Concentrations are given as Geometric Mean Concentrations (GMCs).
| International units per milliliter | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Concentration of Antibodies to Rubella Virus | 59.9 (55.9 to 64.1) | 57.9 (54.4 to 61.7) | 71.4 (65.5 to 77.8) |
Vaccine response to Havrix is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies \[concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)\] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Number of Subjects With Vaccine Response to Havrix | 344 | 345 | 195 |
Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Anti-S.Pneu-4 (n= 461, 463, 266) | 461 | 463 | 266 |
| Anti-S.Pneu-6B (n= 460, 464, 265) | 459 | 463 | 265 |
| Anti-S.Pneu-9V (n= 461, 468, 266) | 461 | 468 | 266 |
| Anti-S.Pneu-14 (n= 460, 465, 266) | 460 | 465 | 266 |
| Anti-S.Pneu-18C (n= 458, 465, 263) | 458 | 465 | 263 |
| Anti-S.Pneu-19F (n= 454, 460, 261) | 454 | 460 | 261 |
| Anti-S.Pneu-23F (n= 459, 464, 266) | 459 | 464 | 266 |
Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Anti-S.Pneu-4 (n= 461, 463, 266) | 461 | 463 | 266 |
| Anti-S.Pneu-6B (n= 460, 464, 265) | 458 | 460 | 265 |
| Anti-S.Pneu-9V (n= 461, 468, 266) | 461 | 468 | 266 |
| Anti-S.Pneu-14 (n= 460, 465, 266) | 460 | 465 | 266 |
| Anti-S.Pneu-18C (n= 458, 465, 263) | 458 | 464 | 263 |
| Anti-S.Pneu-19F (n= 454, 460, 261) | 451 | 459 | 259 |
| Anti-S.Pneu-23F (n= 459, 464, 266) | 459 | 464 | 266 |
Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Anti-S.Pneu-4 (n= 461, 463, 266) | 456 | 459 | 265 |
| Anti-S.Pneu-6B (n= 460, 464, 265) | 453 | 459 | 264 |
| Anti-S.Pneu-9V (n= 461, 468, 266) | 459 | 466 | 266 |
| Anti-S.Pneu-14 (n= 460, 465, 266) | 459 | 464 | 266 |
| Anti-S.Pneu-18C (n= 458, 465, 263) | 458 | 463 | 263 |
| Anti-S.Pneu-19F (n= 454, 460, 261) | 431 | 448 | 249 |
| Anti-S.Pneu-23F (n= 459, 464, 266) | 458 | 462 | 266 |
Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Anti-S.Pneu-4 (n= 461, 463, 266) | 437 | 423 | 249 |
| Anti-S.Pneu-6B (n= 460, 464, 265) | 442 | 453 | 259 |
| Anti-S.Pneu-9V (n= 461, 468, 266) | 450 | 459 | 265 |
| Anti-S.Pneu-14 (n= 460, 465, 266) | 458 | 463 | 266 |
| Anti-S.Pneu-18C (n= 458, 465, 263) | 446 | 455 | 259 |
| Anti-S.Pneu-19F (n= 454, 460, 261) | 390 | 390 | 214 |
| Anti-S.Pneu-23F (n= 459, 464, 266) | 446 | 458 | 265 |
Solicited local symptoms assessed include pain, redness and swelling.
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Pain | 136 | 114 | 65 |
| Redness | 111 | 120 | 54 |
| Swelling | 50 | 49 | 21 |
Fever was measured rectally.
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| ≥ 38.0°C/100.4°F | 248 | 241 | 120 |
| > 39.5°C/103.1°F | 33 | 48 | 14 |
Fever was measured rectally.
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| ≥ 38.0°C/100.4°F | 312 | 301 | 162 |
| > 39.5°C/103.1°F | 52 | 71 | 24 |
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash | 37 | 25 | 15 |
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Number of Subjects Reporting Investigator-confirmed Varicella-like Rash | 10 | 9 | 6 |
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling | 14 | 7 | 5 |
Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel.
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Unsolicited adverse events | 338 | 332 | 191 |
| Medically-attended adverse events | 217 | 213 | 124 |
New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| New onsets of chronic diseases | 11 | 11 | 7 |
| Emergency room visits | 63 | 63 | 44 |
Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
| subjects | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | ProQuad Group |
|---|---|---|---|
| Number of Subjects Reporting Serious Adverse Events | 14 | 20 | 7 |
Collected over Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | 0/705 (0%) | 14/705 (2%) | 547/705 (77.6%) |
| Freezer-stored Priorix-Tetra Group | 0/689 (0%) | 20/689 (2.9%) | 541/689 (78.5%) |
| Proquad Group | 0/389 (0%) | 7/389 (1.8%) | 297/389 (76.3%) |
| Event | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group |
|---|---|---|---|
| PneumoniaInfections and infestations | 0/705 | 0/689 | 2/389 |
| GastroenteritisInfections and infestations | 1/705 | 2/689 | 0/389 |
| Bronchial hyperreactivityRespiratory, thoracic and mediastinal disorders | 0/705 | 2/689 | 0/389 |
| Febrile convulsionNervous system disorders | 0/705 | 2/689 | 0/389 |
| Groin abscessInfections and infestations | 0/705 | 2/689 | 0/389 |
| CellulitisInfections and infestations | 2/705 | 0/689 | 0/389 |
| Acute sinusitisInfections and infestations | 0/705 | 0/689 | 1/389 |
| BronchiolitisInfections and infestations | 0/705 | 0/689 | 1/389 |
| Foreign body traumaInjury, poisoning and procedural complications | 0/705 | 0/689 | 1/389 |
| Gastroenteritis rotavirusInfections and infestations | 0/705 | 0/689 | 1/389 |
| Event | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group |
|---|---|---|---|
| FeverGeneral disorders | 312/676 | 302/668 | 163/379 |
| RashGeneral disorders | 221/676 | 219/668 | 128/379 |
| PainGeneral disorders | 136/673 | 114/666 | 65/378 |
| RednessGeneral disorders | 111/673 | 120/666 | 54/378 |
| Uper respiratory tract infectionInfections and infestations | 49/705 | 58/689 | 42/389 |
| Otitis mediaInfections and infestations | 71/705 | 62/689 | 34/389 |
| TeethingGastrointestinal disorders | 42/705 | 53/689 | 28/389 |
| DiarrhoeaGastrointestinal disorders | 37/705 | 46/689 | 29/389 |
| SwellingGeneral disorders | 50/673 | 49/666 | 21/378 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 29/705 | 21/689 | 24/389 |
| Age, Continuous(months) | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group | Total |
|---|---|---|---|---|
| Mean | 12.3 ± 0.58 | 12.3 ± 0.59 | 12.3 ± 0.61 | 12.3 ± 0.59 |
| Sex: Female, Male(Participants) | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group | Total |
|---|---|---|---|---|
| Female | 356 | 346 | 186 | 888 |
| Male | 349 | 343 | 203 | 895 |
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