Hepatitis A
Conditions
Brief summary
This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age.
Detailed description
An open, controlled comparison of Havrix administered alone or with Prevnar. The three groups evaluated are: 1) Havrix alone, 2) Havrix plus Prevnar and 3) Prevnar followed by Havrix one month later.
Interventions
BIOLOGICALGSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)
Two doses, administered intramuscularly in the right anterolateral thigh.
BIOLOGICALPrevnar™
One dose, administered intramuscularly in the left anterolateral thigh.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 13 Months
Healthy volunteers
Yes
Inclusion criteria
* A male or female child 12 or 13 months of age at the time of entry into the Enrollment Phase, * Free of obvious health problems, * Subjects must have previously received three doses of Prevnar in his/her first year of life.
Exclusion criteria
* Use of any investigational or non-registered drug or vaccine within 42 days preceding the first dose of study vaccine, or planned use during the study period, * Chronic administration of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, less than 0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.), * Administration of the ACIP-recommended fourth dose of Prevnar prior to entering the Enrollment Phase of the study, * Planned administration or administration of any vaccine not foreseen by the study protocol within the period of 42 days before and 30 days after each dose of study vaccine(s), * Previous vaccination against hepatitis A, * History of hepatitis A or known exposure to hepatitis A, * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, * A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection, * History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of Havrix (e.g., neomycin, 2-phenoxyethanol) or Prevnar (e.g., diphtheria toxoid), * Major congenital defects or serious chronic illness, * History of any neurologic disorder (history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject), * Acute disease, defined as the presence of a moderate or severe illness with or without fever, at the time of vaccination, * Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seropositive Subjects for Anti-HAV Antibodies | At one month after Dose 2 of Havrix® vaccine (Month 7-10) | Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination. |
| Concentrations for Anti-HAV Antibodies | At one month after Dose 2 of Havrix® vaccine (Month 7-10) | Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seropositive Subjects for Anti-HAV Antibodies | At one month after Dose 1 of Havrix® vaccine (Day 30) | Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination. |
| Concentrations for Anti-HAV Antibodies | At one month after Dose 1 of Havrix® vaccine (Day 30) | Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL). |
| Number of Subjects With Vaccine Response to Anti-HAV Antibodies | One month after Dose 2 of Havrix® vaccine (Month 7-10/8-10) | The vaccine response was defined as: 1. a detectable anti-HAV antibody concentration one month after Dose 2 in subjects who were initially seronegative (antibody concentrations \< 15 mIU/mL for anti-HAV); or 2. a 2-fold increase above the pre-vaccination concentration one month after Dose 2 in subjects who were initially seropositive (antibody concentrations ≥ 15 mIU/mL for anti-HAV). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses | 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. |
| Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | At one month after Prevnar™ vaccination (Day 30) | Antibody concentrations against pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL). |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 31-day (Day 0-30) follow-up period | 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 and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs) | During the Active Phase (from Day 0 to Day 30 after final vaccine dose for each subject) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects With SAEs, NCIs and MSEs | During the Extended Safety Follow-up (ESFU) Phase (from Day 30 to 6 months after final vaccine dose) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses | Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | At one month after Prevnar™ vaccination (Day 30) | The immune response was defined, with respect to anti-pneumococcal response rates, as an antibody concentration equal to or above (≥) 0.05 μg/mL. |
Countries
United States
Participant flow
Pre-assignment details
Out of a total of 521 subjects enrolled, 88 subjects were not administered a study vaccine dose and thus were not considered to have started the study.
Participants by arm
| Arm | Count |
|---|---|
| Havrix Group Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9. | 147 |
| Havrix+Prevnar Group Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9. | 137 |
| Prevnar Havrix Group Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10. | 149 |
| Total | 433 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Lost to follow-up (compl. vaccination) | 2 | 2 | 1 |
| Overall Study | Lost to follow-up (incompl. vaccination) | 4 | 4 | 5 |
| Overall Study | Migrated/moved from study area | 3 | 5 | 1 |
| Overall Study | Others | 3 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 5 | 7 |
Baseline characteristics
| Characteristic | Havrix Group | Havrix+Prevnar Group | Prevnar Havrix Group | Total |
|---|---|---|---|---|
| Age, Continuous | 15.0 Months STANDARD_DEVIATION 0.16 | 15.0 Months STANDARD_DEVIATION 0.09 | 15.0 Months STANDARD_DEVIATION 0.24 | 15.0 Months STANDARD_DEVIATION 0.18 |
| Sex: Female, Male Female | 77 Participants | 66 Participants | 79 Participants | 222 Participants |
| Sex: Female, Male Male | 70 Participants | 71 Participants | 70 Participants | 211 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 107 / 147 | 106 / 137 | 121 / 149 |
| serious Total, serious adverse events | 6 / 177 | 8 / 169 | 10 / 175 |
Outcome results
Primary
Concentrations for Anti-HAV Antibodies
Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time frame: At one month after Dose 2 of Havrix® vaccine (Month 7-10)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Havrix Group | Concentrations for Anti-HAV Antibodies | 1609.9 mIU/mL |
| Havrix+Prevnar Group | Concentrations for Anti-HAV Antibodies | 1526.4 mIU/mL |
Comparison: To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10).95% CI: [0.63, 1.31]ANCOVA
Primary
Number of Seropositive Subjects for Anti-HAV Antibodies
Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination.
Time frame: At one month after Dose 2 of Havrix® vaccine (Month 7-10)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Havrix Group | Number of Seropositive Subjects for Anti-HAV Antibodies | 106 Participants |
| Havrix+Prevnar Group | Number of Seropositive Subjects for Anti-HAV Antibodies | 94 Participants |
Comparison: Difference in seropositivity rates for anti-HAV:~To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10).95% CI: [-5.78, 2.45]
Secondary
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations
Antibody concentrations against pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL).
Time frame: At one month after Prevnar™ vaccination (Day 30)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Havrix Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-9V | 6.8 μg/mL |
| Havrix Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-18C | 5.8 μg/mL |
| Havrix Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-6B | 7.1 μg/mL |
| Havrix Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-19F | 2.8 μg/mL |
| Havrix Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-14 | 9.8 μg/mL |
| Havrix Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-23F | 9.0 μg/mL |
| Havrix Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-4 | 3.3 μg/mL |
| Havrix+Prevnar Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-23F | 7.9 μg/mL |
| Havrix+Prevnar Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-4 | 3.1 μg/mL |
| Havrix+Prevnar Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-6B | 6.1 μg/mL |
| Havrix+Prevnar Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-9V | 7.4 μg/mL |
| Havrix+Prevnar Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-14 | 11.2 μg/mL |
| Havrix+Prevnar Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-18C | 5.7 μg/mL |
| Havrix+Prevnar Group | Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations | Anti-19F | 2.6 μg/mL |
Secondary
Concentrations for Anti-HAV Antibodies
Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).
Time frame: At one month after Dose 2 of Havrix® vaccine (Month 8-11)
Population: The analysis was performed on the ATP Cohort for Immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Havrix Group | Concentrations for Anti-HAV Antibodies | 1391.2 mIU/mL |
Secondary
Concentrations for Anti-HAV Antibodies
Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).
Time frame: At one month after Dose 1 of Havrix® vaccine (Day 30)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Havrix Group | Concentrations for Anti-HAV Antibodies | 48.0 mIU/mL |
| Havrix+Prevnar Group | Concentrations for Anti-HAV Antibodies | 61.0 mIU/mL |
Secondary
Number of Seropositive Subjects for Anti-HAV Antibodies
Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.
Time frame: At one month after Dose 1 of Havrix® vaccine (Day 30)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Havrix Group | Number of Seropositive Subjects for Anti-HAV Antibodies | 100 Participants |
| Havrix+Prevnar Group | Number of Seropositive Subjects for Anti-HAV Antibodies | 91 Participants |
Secondary
Number of Seropositive Subjects for Anti-HAV Antibodies
Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.
Time frame: At one month after Dose 2 of Havrix® vaccine (Month 8-11)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Havrix Group | Number of Seropositive Subjects for Anti-HAV Antibodies | 113 Participants |
Secondary
Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
The immune response was defined, with respect to anti-pneumococcal response rates, as an antibody concentration equal to or above (≥) 0.05 μg/mL.
Time frame: At one month after Prevnar™ vaccination (Day 30)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Havrix Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-9V | 101 Participants |
| Havrix Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-18C | 101 Participants |
| Havrix Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-6B | 100 Participants |
| Havrix Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-19F | 101 Participants |
| Havrix Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-14 | 101 Participants |
| Havrix Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-23F | 100 Participants |
| Havrix Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-4 | 102 Participants |
| Havrix+Prevnar Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-23F | 115 Participants |
| Havrix+Prevnar Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-4 | 115 Participants |
| Havrix+Prevnar Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-6B | 115 Participants |
| Havrix+Prevnar Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-9V | 116 Participants |
| Havrix+Prevnar Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-14 | 116 Participants |
| Havrix+Prevnar Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-18C | 114 Participants |
| Havrix+Prevnar Group | Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Anti-19F | 116 Participants |
Secondary
Number of Subjects With 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: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 30 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 31 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 39 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 0 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 12 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 34 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 19 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 0 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 9 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 0 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 57 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 45 Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 5 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 48 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 62 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 3 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 34 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 64 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 8 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 47 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 6 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 54 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 28 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 18 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 7 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 39 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 2 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 2 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 61 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 64 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 7 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 38 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 2 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 35 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 37 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 17 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 29 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 | 32 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 0 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 16 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 76 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 2 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 78 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 7 Participants |
| Prevnar Havrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 48 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 18 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 2 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 34 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 12 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 11 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 48 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 44 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 36 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 1 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 31 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 40 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 16 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 12 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 12 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 28 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 1 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 26 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 15 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 1 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 14 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | NA Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across | 48 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across | 2 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across | 41 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across | 21 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across | 1 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across | 20 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across | 60 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across | 1 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across | 55 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across | 42 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across | 2 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across | 37 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across | 4 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 6 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 36 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across | 47 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 34 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 20 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across | 24 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 2 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 17 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across | 45 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across | 2 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across | 17 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across | 36 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across | 65 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 35 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 2 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 34 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across | 4 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 19 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 1 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 11 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across | 0 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 47 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 44 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 33 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 2 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 24 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 27 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across | 49 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 2 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 25 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across | 63 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 7 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across | 82 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 1 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 2 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across | 6 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 45 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 7 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across | 79 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across | 63 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 42 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 50 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 3 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 1 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across | 58 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 27 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 40 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across | 49 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across | 3 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 24 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 39 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 28 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across | 31 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 35 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 21 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 23 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 10 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 20 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 25 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 2 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across | 4 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 16 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 18 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across | 54 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 2 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 10 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 18 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 14 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 1 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across | 26 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 9 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 58 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 27 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 27 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across | 3 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 2 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (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 and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 31-day (Day 0-30) follow-up period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 3 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 82 Participants |
| Havrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 8 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 5 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 72 Participants |
| Havrix+Prevnar Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 8 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 87 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 12 Participants |
| Prevnar Havrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 8 Participants |
Secondary
Number of Subjects With SAEs, NCIs and MSEs
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: During the Extended Safety Follow-up (ESFU) Phase (from Day 30 to 6 months after final vaccine dose)
Population: The analysis was performed on the ESFU cohort, which included all vaccinated subjects for whom safety data were available during the extended safety follow-up period (from Day 30 up to 6 months after last vaccine dose).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Havrix Group | Number of Subjects With SAEs, NCIs and MSEs | Any NCI(s) | NA Participants |
| Havrix Group | Number of Subjects With SAEs, NCIs and MSEs | Any SAE(s) | 0 Participants |
| Havrix Group | Number of Subjects With SAEs, NCIs and MSEs | Any MSE(s) | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With SAEs, NCIs and MSEs | Any NCI(s) | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With SAEs, NCIs and MSEs | Any SAE(s) | 2 Participants |
| Havrix+Prevnar Group | Number of Subjects With SAEs, NCIs and MSEs | Any MSE(s) | NA Participants |
| Prevnar Havrix Group | Number of Subjects With SAEs, NCIs and MSEs | Any SAE(s) | 3 Participants |
| Prevnar Havrix Group | Number of Subjects With SAEs, NCIs and MSEs | Any MSE(s) | NA Participants |
| Prevnar Havrix Group | Number of Subjects With SAEs, NCIs and MSEs | Any NCI(s) | NA Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: During the Active Phase (from Day 0 to Day 30 after final vaccine dose for each subject)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Havrix Group | Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs) | Any NCI(s) | NA Participants |
| Havrix Group | Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs) | Any SAE(s) | 3 Participants |
| Havrix Group | Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs) | Any MSE(s) | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs) | Any NCI(s) | NA Participants |
| Havrix+Prevnar Group | Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs) | Any SAE(s) | 5 Participants |
| Havrix+Prevnar Group | Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs) | Any MSE(s) | NA Participants |
| Prevnar Havrix Group | Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs) | Any SAE(s) | 5 Participants |
| Prevnar Havrix Group | Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs) | Any MSE(s) | NA Participants |
| Prevnar Havrix Group | Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs) | Any NCI(s) | NA Participants |
Secondary
Number of Subjects With Vaccine Response to Anti-HAV Antibodies
The vaccine response was defined as: 1. a detectable anti-HAV antibody concentration one month after Dose 2 in subjects who were initially seronegative (antibody concentrations \< 15 mIU/mL for anti-HAV); or 2. a 2-fold increase above the pre-vaccination concentration one month after Dose 2 in subjects who were initially seropositive (antibody concentrations ≥ 15 mIU/mL for anti-HAV).
Time frame: One month after Dose 2 of Havrix® vaccine (Month 7-10/8-10)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Havrix Group | Number of Subjects With Vaccine Response to Anti-HAV Antibodies | 102 Participants |
| Havrix+Prevnar Group | Number of Subjects With Vaccine Response to Anti-HAV Antibodies | 89 Participants |
| Prevnar Havrix Group | Number of Subjects With Vaccine Response to Anti-HAV Antibodies | 110 Participants |