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The purpose of this study is to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.
In this study Influenza vaccine GSK1562902A is the primary study vaccine and Havrix™ will be administered as the active comparator and not co-administered along with the study vaccine.Therefore, there exist no relation between the vaccines administered in this study. As the study will be carried out in Philippines, Havrix™ vaccine will be used as an active comparator instead of saline placebo to offer an advantage to the subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group | Experimental | Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
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| GSK1562902A Formulation 1 - Havrix / Havrix Jr Group | Experimental | Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
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| GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Active Comparator | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
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| Havrix / Havrix Jr Group | Active Comparator | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine GSK1562902A Formulation 1 | Biological | Intramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group |
| Measure | Description | Time Frame |
|---|---|---|
| Haemagglutination Inhibition (HI) Antibody Titers for the A/Turkey/Turkey/01/2005 (H5N1) Vaccine Strain. | Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. | At Day 192. |
| Number of Subjects With Any Medically Attended Adverse Events (MAEs) | Any = occurrence of the symptom regardless of intensity grade. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. | From Day 0 to Day 182 |
| Number of Subjects With Any Medically Attended Adverse Events (MAEs) | Any = occurrence of the symptom regardless of intensity grade. | From Day 0 to Day 364. |
| Measure | Description | Time Frame |
|---|---|---|
| H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains | The antibody titres were given as Geometric Mean Titer (GMT). A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK. | At Days 0, 42, 182, 192, 364 |
| H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains |
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Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
Subjects for whom the investigator believes that the parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol .
A male or female child 3 to 17 years of age inclusive, at the time of the first vaccination.
Written informed consent obtained from the subject's parent or guardian. Assent obtained from the subject when applicable.
Good general health as established by medical history and clinical examination before entering into the study.
Comprehension by the subject's parent or guardian of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Alabang, Muntinlupa | 1781 | Philippines | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26551446 | Derived | Izurieta P, Uy-Aragon MJ, Drame M, Vaughn DW. Assessment of Prime-boost Vaccination Using an AS03B-adjuvanted Influenza A (H5N1) Vaccine: A Randomized Trial in Children of Three to Less Than Eighteen Years of Age. Pediatr Infect Dis J. 2016 Feb;35(2):e35-47. doi: 10.1097/INF.0000000000000968. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 115115 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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The study was of an overall duration 364 days for all subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group | Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Influenza vaccine GSK1562902A Formulation 2 | Biological | Intramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group |
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| Havrix™ | Biological | Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group |
|
| Havrix™ Junior | Biological | Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group |
|
Antibody titers were given as GMTs. A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK. |
| At Days 0, 42, 182, 192, 364 |
| Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed. | During a 7-day (Day 0-6) follow-up period after each vaccination |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were diarrhea/vomiting, drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged less than 6 years. | During a 7-day (Day 0-6) follow-up period after each vaccination |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia and temperature[defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged 6 years or more. | During a 7-day (Day 0-6) follow-up period after vaccination |
| 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. | During a 21-day (Days 0 - 20) follow-up period after vaccination |
| 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. | During Day 0 to Telephone Contact (TC) Day 84 overall. |
| Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | During the entire study period (Day 0 to 364) |
| Number of Subjects With Serious Adverse Events (SAEs). | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (Day 0 to 364) |
| Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10 | Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182, 192 and 364. | At Days 0, 42, 182, 192 and 364 |
| Number of Seroconverted Subjects Against the A/Indonesia/05/2005 Strains of H5N1 Influenza Disease | A seroconverted subject was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Seroconversion rates against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. | At Days 42, 182, 192 and 364 |
| Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Seroprotection rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated 95% CI on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 -Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seroprotection rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182 and 192. | At Days 0,42, 182, 192 and 364 |
| Mean Geometric Increase for Anti-H5N1 Antibody Titers | MGI against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. MGI against the A/turkey/Turkey/01/2005 (H5N1 virus) strain were tabulated on Days 42, 182 and 364. | At Days 42, 182, 192 and 364 |
| Number of Seroconverted Subjects Against the A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease | Booster seroconversion rates against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated on Days 192 and 364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. | At Days 192 and 364 |
| Booster Factor for Hemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/01/2005 Strain of H5N1 Influenza Disease | Boooster factor against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated 95% CI on Days 192,364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. | At Days 192 and 364 |
| Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers | Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 0, 42,182, 192 and 364. | At Days 0, 42, 182 192 and 364 |
| Number of Subjects With Vaccine Response Rates (VRR) for H5N1 Neutralizing Antibodies | At Days 42, 182 192 and 364 |
| Number of Subjects With Booster Vaccine Response for H5N1 Neutralizing Antibodies | This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. | At Days 192 and 364 |
| Quezon City |
| 1113 |
| Philippines |
For additional information about this study please refer to the GSK Clinical Study Register |
| 115115 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115115 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115115 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115115 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115115 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 |
| GSK1562902A Formulation 1 - Havrix / Havrix Jr Group |
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| FG002 | GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| FG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group | Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| BG001 | GSK1562902A Formulation 1 - Havrix / Havrix Jr Group | Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| BG002 | GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| BG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Haemagglutination Inhibition (HI) Antibody Titers for the A/Turkey/Turkey/01/2005 (H5N1) Vaccine Strain. | Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 192. |
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| Primary | Number of Subjects With Any Medically Attended Adverse Events (MAEs) | Any = occurrence of the symptom regardless of intensity grade. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. | The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | From Day 0 to Day 182 |
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| Primary | Number of Subjects With Any Medically Attended Adverse Events (MAEs) | Any = occurrence of the symptom regardless of intensity grade. | The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | From Day 0 to Day 364. |
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| Secondary | H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains | The antibody titres were given as Geometric Mean Titer (GMT). A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Days 0, 42, 182, 192, 364 |
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| Secondary | H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains | Antibody titers were given as GMTs. A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Days 0, 42, 182, 192, 364 |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed. | The analysis was based on the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | During a 7-day (Day 0-6) follow-up period after each vaccination |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were diarrhea/vomiting, drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged less than 6 years. | The analysis was based on subjects aged less than 6 years, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | During a 7-day (Day 0-6) follow-up period after each vaccination |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia and temperature[defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged 6 years or more. | The analysis was based on subjects aged 6 years or more, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | During a 7-day (Day 0-6) follow-up period after vaccination |
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| 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. | The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | During a 21-day (Days 0 - 20) follow-up period after vaccination |
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| 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. | The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | During Day 0 to Telephone Contact (TC) Day 84 overall. |
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| Secondary | Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | During the entire study period (Day 0 to 364) |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs). | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | During the entire study period (Day 0 to 364) |
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| Secondary | Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10 | Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182, 192 and 364. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine. | Posted | Number | Subjects | At Days 0, 42, 182, 192 and 364 |
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| Secondary | Number of Seroconverted Subjects Against the A/Indonesia/05/2005 Strains of H5N1 Influenza Disease | A seroconverted subject was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Seroconversion rates against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine. | Posted | Number | Subjects | At Days 42, 182, 192 and 364 |
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| Secondary | Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Seroprotection rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated 95% CI on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 -Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seroprotection rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182 and 192. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine. | Posted | Number | Subjects | At Days 0,42, 182, 192 and 364 |
| |||||||||||||||||||||||||||||||
| Secondary | Mean Geometric Increase for Anti-H5N1 Antibody Titers | MGI against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. MGI against the A/turkey/Turkey/01/2005 (H5N1 virus) strain were tabulated on Days 42, 182 and 364. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Days 42, 182, 192 and 364 |
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| Secondary | Number of Seroconverted Subjects Against the A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease | Booster seroconversion rates against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated on Days 192 and 364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine. | Posted | Number | Subjects | At Days 192 and 364 |
| |||||||||||||||||||||||||||||||
| Secondary | Booster Factor for Hemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/01/2005 Strain of H5N1 Influenza Disease | Boooster factor against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated 95% CI on Days 192,364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Days 192 and 364 |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers | Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 0, 42,182, 192 and 364. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine. | Posted | Number | Subjects | At Days 0, 42, 182 192 and 364 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Vaccine Response Rates (VRR) for H5N1 Neutralizing Antibodies | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine. | Posted | Number | Subjects | At Days 42, 182 192 and 364 |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Booster Vaccine Response for H5N1 Neutralizing Antibodies | This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine. | Posted | Number | Subjects | At Days 192 and 364 |
|
Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group | Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. | 4 | 156 | 138 | 156 | ||
| EG001 | GSK1562902A Formulation 1 - Havrix / Havrix Jr Group | Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. | 1 | 156 | 145 | 156 | ||
| EG002 | GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. | 0 | 104 | 87 | 104 | ||
| EG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. | 0 | 104 | 77 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Open wound | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Typhoid fever | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea/vomiting | General disorders | MedDRA | Systematic Assessment | AE reported for subjects aged less than 6 years. |
|
| Drowsiness | General disorders | MedDRA | Systematic Assessment | AE reported for subjects aged less than 6 years. |
|
| Irritability / fussiness | General disorders | MedDRA | Systematic Assessment | AE reported for subjects aged less than 6 years. |
|
| Loss of appetite | General disorders | MedDRA | Systematic Assessment | AE reported for subjects aged less than 6 years. |
|
| Temperature | General disorders | MedDRA | Systematic Assessment | AE reported for subjects aged less than 6 years. |
|
| Arthralgia | General disorders | MedDRA | Systematic Assessment | AE reported for subjects aged 6 years or more. |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment | AE reported for subjects aged 6 years or more. |
|
| Gastrointestinal symptoms | General disorders | MedDRA | Systematic Assessment | AE reported for subjects aged 6 years or more. |
|
| Headache | General disorders | MedDRA | Systematic Assessment | AE reported for subjects aged 6 years or more. |
|
| Myalgia | General disorders | MedDRA | Systematic Assessment | AE reported for subjects aged 6 years or more. |
|
| Temperature | General disorders | MedDRA | Systematic Assessment | AE reported for subjects aged 6 years or more. |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment | AE reported within 21 days post-vaccination. |
|
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment | AE reported within 21 days post-vaccination. |
|
| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment | AE reported within 21 days post-vaccination. |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment | AE reported from Day 0 up to Day 84 post-vaccination. |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment | AE reported from Day 0 up to Day 84 post-vaccination. |
|
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment | AE reported from Day 0 up to Day 84 post-vaccination. |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| Participants |
|
|
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
| GSK1562902A Formulation 2 - Havrix / Havrix Jr Group |
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
| OG002 | GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
| OG002 | GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
| OG002 | GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
| OG002 | GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region |
|
|
| OG003 |
| Havrix / Havrix Jr Group |
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
| OG002 | GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG002 | GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG002 | GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
| OG002 | GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
|
|
|
|
| OG002 | GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
| OG003 | Havrix / Havrix Jr Group | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|