Varicella, Rubella, Mumps, Measles
Conditions
Keywords
Vaccines, Rubella, Varicella Vaccine, Children, Humans, Mumps, Immunogenicity, Safety, Measles, Combined Vaccine
Brief summary
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.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 14 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol. * Male or female between 12 and 14 months of age at the time of first vaccination. * Written informed consent obtained from the parent/guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Have previously received 3 doses of 7-valent pneumococcal conjugate vaccine within the first year of life.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * 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-investigational product. * 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 from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine. * Previous vaccination against measles, mumps, rubella and/or varicella. * Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine. * History of measles, mumps, rubella and/or varicella/zoster diseases. * Known exposure to measles, mumps, rubella and/or varicella/zoster 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, including human immunodeficiency virus infection. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. Uncomplicated febrile convulsions are not an exclusion criterion. * Residence in the same household as the following persons: * New-born infants (0-4 weeks of age). * Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox. * Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history. * Persons with known immunodeficiency. * Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness. * Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period. * Contra-indications to commercially available vaccines used in this study (Havrix®, Prevnar®, ProQuad®).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV) | At Day 42 after vaccination | 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. |
| Concentration of Antibodies to Varicella Virus (VZV) | At Day 42 after vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs). |
| Number of Subjects With Seroresponse for Antibodies to Mumps Virus | At Day 42 after vaccination | 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. |
| Number of Subjects With Seroresponse for Antibodies to Measles Virus | At Day 42 after vaccination | 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. |
| Number of Subjects With Seroresponse for Antibodies to Rubella Virus | At Day 42 after vaccination | 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. |
| Concentration of Antibodies to Hepatitis A Virus (HAV) | At Day 42 after vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs). |
| Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | At Day 42 after vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | During the 43-day follow-up period following vaccination | Fever was measured rectally. |
| Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash | During the 43-day follow-up period after vaccination | — |
| Number of Subjects Reporting Investigator-confirmed Varicella-like Rash | During the 43-day follow-up period after vaccination | — |
| Antibody Titers to Mumps Virus | At Day 42 after vaccination | 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. |
| Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling) | During the 43-day follow-up period after vaccination | 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. |
| Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits | For approximately 6 months (Day 0-180) | New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies. |
| Number of Subjects Reporting Serious Adverse Events | For approximately 6 months (Day 0-180) | 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. |
| Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling | During the 43-day follow-up period after vaccination | — |
| Concentration of Antibodies to Measles Virus | At Day 42 after vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs). |
| Concentration of Antibodies to Rubella Virus | At Day 42 after vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs). |
| Number of Subjects With Vaccine Response to Havrix | At Day 42 after vaccination | 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. |
| 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 | At Day 42 after vaccination | Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL). |
| Number of Subjects Reporting Solicited Local Symptoms | During the 4 day follow up period following vaccination | Solicited local symptoms assessed include pain, redness and swelling. |
| 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 | During the 15-day follow-up period following vaccination | Fever was measured rectally. |
Countries
United States
Participant flow
Pre-assignment details
While the total numbers of subjects enrolled in the study was of 1851, the total number of subjects that entered the study was 1783. The remaining 67 subjects received a subject number but no vaccine dose and were therefore excluded from the analysis and group assignment.
Participants by arm
| Arm | Count |
|---|---|
| Refrigerator-stored Priorix-Tetra Group Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh. | 705 |
| Freezer-stored Priorix-Tetra Group Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh. | 689 |
| Proquad Group Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly. | 389 |
| Total | 1,783 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 |
| Overall Study | Other reasons | 70 | 42 | 23 |
Baseline characteristics
| Characteristic | Refrigerator-stored Priorix-Tetra Group | Freezer-stored Priorix-Tetra Group | Proquad Group | Total |
|---|---|---|---|---|
| Age, Continuous | 12.3 months STANDARD_DEVIATION 0.58 | 12.3 months STANDARD_DEVIATION 0.59 | 12.3 months STANDARD_DEVIATION 0.61 | 12.3 months STANDARD_DEVIATION 0.59 |
| Sex: Female, Male Female | 356 Participants | 346 Participants | 186 Participants | 888 Participants |
| Sex: Female, Male Male | 349 Participants | 343 Participants | 203 Participants | 895 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 705 | 0 / 689 | 0 / 389 |
| other Total, other adverse events | 547 / 705 | 541 / 689 | 297 / 389 |
| serious Total, serious adverse events | 14 / 705 | 20 / 689 | 7 / 389 |
Outcome results
Primary
Concentration of Antibodies to Hepatitis A Virus (HAV)
Concentrations are given as Geometric Mean Concentrations (GMCs).
Time frame: At Day 42 after vaccination
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Concentration of Antibodies to Hepatitis A Virus (HAV) | 40.5 milli-international units per milliliter |
| Freezer-stored Priorix-Tetra Group | Concentration of Antibodies to Hepatitis A Virus (HAV) | 40.3 milli-international units per milliliter |
| Proquad Group | Concentration of Antibodies to Hepatitis A Virus (HAV) | 40.0 milli-international units per milliliter |
Primary
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
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.6B (n= 460, 464, 265) | 5.65 micrograms per milliliter (µg/mL) |
| Refrigerator-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.18C (n= 458, 465, 263) | 5.50 micrograms per milliliter (µg/mL) |
| Refrigerator-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.14 (n= 460, 465, 266) | 9.71 micrograms per milliliter (µg/mL) |
| Refrigerator-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.4 (n= 461, 463, 266) | 3.35 micrograms per milliliter (µg/mL) |
| Refrigerator-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.23F (n= 459, 464, 266) | 10.10 micrograms per milliliter (µg/mL) |
| Refrigerator-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.19F (n= 454, 460, 261) | 2.52 micrograms per milliliter (µg/mL) |
| Refrigerator-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.9V (n=461, 468, 266) | 5.81 micrograms per milliliter (µg/mL) |
| Freezer-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.14 (n= 460, 465, 266) | 9.54 micrograms per milliliter (µg/mL) |
| Freezer-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.4 (n= 461, 463, 266) | 3.31 micrograms per milliliter (µg/mL) |
| Freezer-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.6B (n= 460, 464, 265) | 5.91 micrograms per milliliter (µg/mL) |
| Freezer-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.9V (n=461, 468, 266) | 5.66 micrograms per milliliter (µg/mL) |
| Freezer-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.18C (n= 458, 465, 263) | 5.80 micrograms per milliliter (µg/mL) |
| Freezer-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.19F (n= 454, 460, 261) | 2.52 micrograms per milliliter (µg/mL) |
| Freezer-stored Priorix-Tetra Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.23F (n= 459, 464, 266) | 10.85 micrograms per milliliter (µg/mL) |
| Proquad Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.18C (n= 458, 465, 263) | 5.51 micrograms per milliliter (µg/mL) |
| Proquad Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.6B (n= 460, 464, 265) | 5.43 micrograms per milliliter (µg/mL) |
| Proquad Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.23F (n= 459, 464, 266) | 9.79 micrograms per milliliter (µg/mL) |
| Proquad Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.19F (n= 454, 460, 261) | 2.31 micrograms per milliliter (µg/mL) |
| Proquad Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.14 (n= 460, 465, 266) | 8.96 micrograms per milliliter (µg/mL) |
| Proquad Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.9V (n=461, 468, 266) | 5.54 micrograms per milliliter (µg/mL) |
| Proquad Group | Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | S.Pneu.4 (n= 461, 463, 266) | 3.02 micrograms per milliliter (µg/mL) |
Primary
Concentration of Antibodies to Varicella Virus (VZV)
Concentrations are given as Geometric Mean Concentrations (GMCs).
Time frame: At Day 42 after vaccination
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Concentration of Antibodies to Varicella Virus (VZV) | 83.6 milli-international units per milliliter |
| Freezer-stored Priorix-Tetra Group | Concentration of Antibodies to Varicella Virus (VZV) | 109.9 milli-international units per milliliter |
| Proquad Group | Concentration of Antibodies to Varicella Virus (VZV) | 164.3 milli-international units per milliliter |
Primary
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
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects With Seroresponse for Antibodies to Measles Virus | 616 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects With Seroresponse for Antibodies to Measles Virus | 633 subjects |
| Proquad Group | Number of Subjects With Seroresponse for Antibodies to Measles Virus | 342 subjects |
Primary
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
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects With Seroresponse for Antibodies to Mumps Virus | 491 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects With Seroresponse for Antibodies to Mumps Virus | 498 subjects |
| Proquad Group | Number of Subjects With Seroresponse for Antibodies to Mumps Virus | 256 subjects |
Primary
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
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects With Seroresponse for Antibodies to Rubella Virus | 616 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects With Seroresponse for Antibodies to Rubella Virus | 622 subjects |
| Proquad Group | Number of Subjects With Seroresponse for Antibodies to Rubella Virus | 349 subjects |
Primary
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
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV) | 355 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV) | 440 subjects |
| Proquad Group | Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV) | 301 subjects |
Secondary
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
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Antibody Titers to Mumps Virus | 222.4 titer |
| Freezer-stored Priorix-Tetra Group | Antibody Titers to Mumps Virus | 224.6 titer |
| Proquad Group | Antibody Titers to Mumps Virus | 253.1 titer |
Secondary
Concentration of Antibodies to Measles Virus
Concentrations are given as Geometric Mean Concentrations (GMCs).
Time frame: At Day 42 after vaccination
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Concentration of Antibodies to Measles Virus | 4723.1 milli-international units per milliliter |
| Freezer-stored Priorix-Tetra Group | Concentration of Antibodies to Measles Virus | 4650.3 milli-international units per milliliter |
| Proquad Group | Concentration of Antibodies to Measles Virus | 4207.1 milli-international units per milliliter |
Secondary
Concentration of Antibodies to Rubella Virus
Concentrations are given as Geometric Mean Concentrations (GMCs).
Time frame: At Day 42 after vaccination
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Concentration of Antibodies to Rubella Virus | 59.9 International units per milliliter |
| Freezer-stored Priorix-Tetra Group | Concentration of Antibodies to Rubella Virus | 57.9 International units per milliliter |
| Proquad Group | Concentration of Antibodies to Rubella Virus | 71.4 International units per milliliter |
Secondary
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
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | 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 | ≥ 38.0°C/100.4°F | 248 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | > 39.5°C/103.1°F | 33 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | ≥ 38.0°C/100.4°F | 241 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | > 39.5°C/103.1°F | 48 subjects |
| Proquad Group | 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 | ≥ 38.0°C/100.4°F | 120 subjects |
| Proquad Group | 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 | > 39.5°C/103.1°F | 14 subjects |
Secondary
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
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | 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 | ≥ 38.0°C/100.4°F | 312 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | > 39.5°C/103.1°F | 52 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | ≥ 38.0°C/100.4°F | 301 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | > 39.5°C/103.1°F | 71 subjects |
| Proquad Group | 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 | ≥ 38.0°C/100.4°F | 162 subjects |
| Proquad Group | 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 | > 39.5°C/103.1°F | 24 subjects |
Secondary
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash
Time frame: During the 43-day follow-up period after vaccination
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash | 37 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash | 25 subjects |
| Proquad Group | Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash | 15 subjects |
Secondary
Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling
Time frame: During the 43-day follow-up period after vaccination
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling | 14 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling | 7 subjects |
| Proquad Group | Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling | 5 subjects |
Secondary
Number of Subjects Reporting Investigator-confirmed Varicella-like Rash
Time frame: During the 43-day follow-up period after vaccination
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects Reporting Investigator-confirmed Varicella-like Rash | 10 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects Reporting Investigator-confirmed Varicella-like Rash | 9 subjects |
| Proquad Group | Number of Subjects Reporting Investigator-confirmed Varicella-like Rash | 6 subjects |
Secondary
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)
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits | Emergency room visits | 63 subjects |
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits | New onsets of chronic diseases | 11 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits | Emergency room visits | 63 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits | New onsets of chronic diseases | 11 subjects |
| Proquad Group | Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits | Emergency room visits | 44 subjects |
| Proquad Group | Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits | New onsets of chronic diseases | 7 subjects |
Secondary
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)
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects Reporting Serious Adverse Events | 14 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects Reporting Serious Adverse Events | 20 subjects |
| Proquad Group | Number of Subjects Reporting Serious Adverse Events | 7 subjects |
Secondary
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
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 50 subjects |
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 111 subjects |
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 136 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 120 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 114 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 49 subjects |
| Proquad Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 65 subjects |
| Proquad Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 21 subjects |
| Proquad Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 54 subjects |
Secondary
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
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling) | Medically-attended adverse events | 217 subjects |
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling) | Unsolicited adverse events | 338 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling) | Medically-attended adverse events | 213 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling) | Unsolicited adverse events | 332 subjects |
| Proquad Group | Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling) | Unsolicited adverse events | 191 subjects |
| Proquad Group | Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling) | Medically-attended adverse events | 124 subjects |
Secondary
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
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-6B (n= 460, 464, 265) | 453 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-19F (n= 454, 460, 261) | 431 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-23F (n= 459, 464, 266) | 458 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-18C (n= 458, 465, 263) | 458 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-4 (n= 461, 463, 266) | 456 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-9V (n= 461, 468, 266) | 459 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-14 (n= 460, 465, 266) | 459 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-18C (n= 458, 465, 263) | 463 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-14 (n= 460, 465, 266) | 464 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-19F (n= 454, 460, 261) | 448 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-6B (n= 460, 464, 265) | 459 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-9V (n= 461, 468, 266) | 466 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-23F (n= 459, 464, 266) | 462 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-4 (n= 461, 463, 266) | 459 subjects |
| Proquad Group | 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 | Anti-S.Pneu-23F (n= 459, 464, 266) | 266 subjects |
| Proquad Group | 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 | Anti-S.Pneu-4 (n= 461, 463, 266) | 265 subjects |
| Proquad Group | 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 | Anti-S.Pneu-6B (n= 460, 464, 265) | 264 subjects |
| Proquad Group | 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 | Anti-S.Pneu-9V (n= 461, 468, 266) | 266 subjects |
| Proquad Group | 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 | Anti-S.Pneu-14 (n= 460, 465, 266) | 266 subjects |
| Proquad Group | 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 | Anti-S.Pneu-18C (n= 458, 465, 263) | 263 subjects |
| Proquad Group | 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 | Anti-S.Pneu-19F (n= 454, 460, 261) | 249 subjects |
Secondary
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
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-18C (n= 458, 465, 263) | 458 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-19F (n= 454, 460, 261) | 454 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-23F (n= 459, 464, 266) | 459 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-6B (n= 460, 464, 265) | 459 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-9V (n= 461, 468, 266) | 461 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-14 (n= 460, 465, 266) | 460 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-4 (n= 461, 463, 266) | 461 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-18C (n= 458, 465, 263) | 465 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-14 (n= 460, 465, 266) | 465 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-19F (n= 454, 460, 261) | 460 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-4 (n= 461, 463, 266) | 463 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-9V (n= 461, 468, 266) | 468 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-23F (n= 459, 464, 266) | 464 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-6B (n= 460, 464, 265) | 463 subjects |
| Proquad Group | 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 | Anti-S.Pneu-23F (n= 459, 464, 266) | 266 subjects |
| Proquad Group | 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 | Anti-S.Pneu-6B (n= 460, 464, 265) | 265 subjects |
| Proquad Group | 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 | Anti-S.Pneu-18C (n= 458, 465, 263) | 263 subjects |
| Proquad Group | 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 | Anti-S.Pneu-4 (n= 461, 463, 266) | 266 subjects |
| Proquad Group | 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 | Anti-S.Pneu-9V (n= 461, 468, 266) | 266 subjects |
| Proquad Group | 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 | Anti-S.Pneu-14 (n= 460, 465, 266) | 266 subjects |
| Proquad Group | 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 | Anti-S.Pneu-19F (n= 454, 460, 261) | 261 subjects |
Secondary
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
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-4 (n= 461, 463, 266) | 461 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-18C (n= 458, 465, 263) | 458 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-9V (n= 461, 468, 266) | 461 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-14 (n= 460, 465, 266) | 460 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-23F (n= 459, 464, 266) | 459 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-19F (n= 454, 460, 261) | 451 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-6B (n= 460, 464, 265) | 458 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-9V (n= 461, 468, 266) | 468 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-14 (n= 460, 465, 266) | 465 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-4 (n= 461, 463, 266) | 463 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-6B (n= 460, 464, 265) | 460 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-18C (n= 458, 465, 263) | 464 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-19F (n= 454, 460, 261) | 459 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-23F (n= 459, 464, 266) | 464 subjects |
| Proquad Group | 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 | Anti-S.Pneu-18C (n= 458, 465, 263) | 263 subjects |
| Proquad Group | 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 | Anti-S.Pneu-4 (n= 461, 463, 266) | 266 subjects |
| Proquad Group | 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 | Anti-S.Pneu-23F (n= 459, 464, 266) | 266 subjects |
| Proquad Group | 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 | Anti-S.Pneu-19F (n= 454, 460, 261) | 259 subjects |
| Proquad Group | 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 | Anti-S.Pneu-9V (n= 461, 468, 266) | 266 subjects |
| Proquad Group | 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 | Anti-S.Pneu-6B (n= 460, 464, 265) | 265 subjects |
| Proquad Group | 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 | Anti-S.Pneu-14 (n= 460, 465, 266) | 266 subjects |
Secondary
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
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-14 (n= 460, 465, 266) | 458 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-18C (n= 458, 465, 263) | 446 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-9V (n= 461, 468, 266) | 450 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-4 (n= 461, 463, 266) | 437 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-23F (n= 459, 464, 266) | 446 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-19F (n= 454, 460, 261) | 390 subjects |
| Refrigerator-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-6B (n= 460, 464, 265) | 442 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-9V (n= 461, 468, 266) | 459 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-4 (n= 461, 463, 266) | 423 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-14 (n= 460, 465, 266) | 463 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-6B (n= 460, 464, 265) | 453 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-18C (n= 458, 465, 263) | 455 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-19F (n= 454, 460, 261) | 390 subjects |
| Freezer-stored Priorix-Tetra Group | 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 | Anti-S.Pneu-23F (n= 459, 464, 266) | 458 subjects |
| Proquad Group | 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 | Anti-S.Pneu-18C (n= 458, 465, 263) | 259 subjects |
| Proquad Group | 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 | Anti-S.Pneu-14 (n= 460, 465, 266) | 266 subjects |
| Proquad Group | 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 | Anti-S.Pneu-23F (n= 459, 464, 266) | 265 subjects |
| Proquad Group | 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 | Anti-S.Pneu-19F (n= 454, 460, 261) | 214 subjects |
| Proquad Group | 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 | Anti-S.Pneu-9V (n= 461, 468, 266) | 265 subjects |
| Proquad Group | 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 | Anti-S.Pneu-6B (n= 460, 464, 265) | 259 subjects |
| Proquad Group | 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 | Anti-S.Pneu-4 (n= 461, 463, 266) | 249 subjects |
Secondary
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
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Refrigerator-stored Priorix-Tetra Group | Number of Subjects With Vaccine Response to Havrix | 344 subjects |
| Freezer-stored Priorix-Tetra Group | Number of Subjects With Vaccine Response to Havrix | 345 subjects |
| Proquad Group | Number of Subjects With Vaccine Response to Havrix | 195 subjects |