Infections, Streptococcal
Conditions
Keywords
Immunogenicity, Pneumococcal disease, Safety, Booster vaccination, Pneumococcal vaccine
Brief summary
This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination. This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALSynflorix
Intramuscular injection, 1 or 2 doses
BIOLOGICALInfanrix Hexa
1 Intramuscular injection
BIOLOGICALHavrix
1 Intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Months to 21 Months
Healthy volunteers
Yes
Inclusion criteria
* Male or female between, and including, 18-21 months of age at the time of vaccination. * Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study. * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up). * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)). * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease. * Acute disease at the time of enrolment. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster doses of study vaccines. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * Administration of immunoglobulins and/or any blood products within the last 3 months prior to booster or follow-up vaccination or planned administration during the active phase of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) | Within 4 days after the administration of any study vaccine dose | Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited General Symptoms | Within 4 days after the administration of any study vaccine dose | Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as rectal temperature ≥ 38 degrees Celsius. |
| Number of Subjects Reporting Unsolicited Adverse Events | Within 31 days after the administration of any study vaccine dose | An Adverse Event is 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. |
| Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study | Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose) | A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
| Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period | Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
| Number of Subjects Reporting Solicited Local Symptoms | Within 4 days after the administration of any study vaccine dose | Solicited local symptoms assessed include pain, redness and swelling. |
| Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Before (pre) and one month after (post) the administration of Dose 2 | Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8 The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. |
| Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Before (pre) and one month after (post) the administration of Dose 2 | Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL). |
| Anti-hepatitis A Virus Antibodies Concentration | Before (pre) and one month after (post) the administration of Dose 2 | Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL). |
| Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value | Before (pre) and one month after (post) the administration of Dose 2 | Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL. |
| Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Before (pre) and one month after (post) the administration of Dose 2 | Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. |
Countries
Chile
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Synflorix Booster Group Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2). | 84 |
| Synflorix Catch-up Group Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2). | 79 |
| Total | 163 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Visit 3 not done | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Synflorix Booster Group | Synflorix Catch-up Group | Total |
|---|---|---|---|
| Age, Continuous | 18.3 Months STANDARD_DEVIATION 0.44 | 18.3 Months STANDARD_DEVIATION 0.5 | 18.3 Months STANDARD_DEVIATION 0.47 |
| Sex: Female, Male Female | 39 Participants | 44 Participants | 83 Participants |
| Sex: Female, Male Male | 45 Participants | 35 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 78 / 84 | 75 / 79 |
| serious Total, serious adverse events | 1 / 84 | 0 / 79 |
Outcome results
Primary
Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)
Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).
Time frame: Within 4 days after the administration of any study vaccine dose
Population: Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Booster Group | Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) | General symptoms | 6 subjects |
| Synflorix Booster Group | Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) | Any symptoms | 32 subjects |
| Synflorix Booster Group | Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) | Local symptoms | 30 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) | General symptoms | 14 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) | Any symptoms | 36 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) | Local symptoms | 32 subjects |
Secondary
Anti-hepatitis A Virus Antibodies Concentration
Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).
Time frame: Before (pre) and one month after (post) the administration of Dose 2
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Booster Group | Anti-hepatitis A Virus Antibodies Concentration | Pre (N=18; 21) | 30.3 mIU/mL |
| Synflorix Booster Group | Anti-hepatitis A Virus Antibodies Concentration | Post (N=19; 19) | 495.5 mIU/mL |
| Synflorix Catch-up Group | Anti-hepatitis A Virus Antibodies Concentration | Pre (N=18; 21) | 539.9 mIU/mL |
| Synflorix Catch-up Group | Anti-hepatitis A Virus Antibodies Concentration | Post (N=19; 19) | 478.5 mIU/mL |
Secondary
Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study
A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Booster Group | Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study | 1 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study | 0 subjects |
Secondary
Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Booster Group | Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period | 1 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period | 0 subjects |
Secondary
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as rectal temperature ≥ 38 degrees Celsius.
Time frame: Within 4 days after the administration of any study vaccine dose
Population: Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Booster Group | Number of Subjects Reporting Solicited General Symptoms | Irritability | 56 subjects |
| Synflorix Booster Group | Number of Subjects Reporting Solicited General Symptoms | Drowsiness | 33 subjects |
| Synflorix Booster Group | Number of Subjects Reporting Solicited General Symptoms | Loss of appetite | 35 subjects |
| Synflorix Booster Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 30 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Solicited General Symptoms | Loss of appetite | 37 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Solicited General Symptoms | Drowsiness | 36 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Solicited General Symptoms | Irritability | 55 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 40 subjects |
Secondary
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Time frame: Within 4 days after the administration of any study vaccine dose
Population: Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Booster Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 57 subjects |
| Synflorix Booster Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 49 subjects |
| Synflorix Booster Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 44 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 63 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 52 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 47 subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events
An Adverse Event is 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.
Time frame: Within 31 days after the administration of any study vaccine dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Booster Group | Number of Subjects Reporting Unsolicited Adverse Events | 47 subjects |
| Synflorix Catch-up Group | Number of Subjects Reporting Unsolicited Adverse Events | 47 subjects |
Secondary
Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value
Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.
Time frame: Before (pre) and one month after (post) the administration of Dose 2
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Booster Group | Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value | Post (N=19; 19) | 18 subjects |
| Synflorix Booster Group | Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value | Pre (N=18; 21) | 12 subjects |
| Synflorix Catch-up Group | Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value | Post (N=19; 19) | 19 subjects |
| Synflorix Catch-up Group | Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value | Pre (N=18; 21) | 21 subjects |
Secondary
Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value
Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Time frame: Before (pre) and one month after (post) the administration of Dose 2
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Booster Group | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Pre (N= 73; 69) | 72 subjects |
| Synflorix Booster Group | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Post (N= 77; 70) | 77 subjects |
| Synflorix Catch-up Group | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Pre (N= 73; 69) | 44 subjects |
| Synflorix Catch-up Group | Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Post (N= 77; 70) | 70 subjects |
Secondary
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8 The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
Time frame: Before (pre) and one month after (post) the administration of Dose 2
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6B Pre (N=22; 25) | 12 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-18C Post (N=26; 27) | 25 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6B Post (N=24; 27) | 22 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-4 Post (N=24; 18) | 24 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-9V Pre (N=20; 17) | 20 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-1 Pre (N=28; 25) | 12 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-9V Post (N=23; 23) | 23 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-5 Pre (N=19; 23) | 13 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-14 Pre (N=16; 11) | 14 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-7F Pre (N=17; 12) | 16 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-14 Post (N=21; 25) | 21 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-5 Post (N=20; 25) | 20 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-18C Pre (N=29; 28) | 12 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-1 Post (N=25; 25) | 25 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19A Pre (N=18; 18) | 0 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19A Post (N=23; 19) | 14 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6A Pre (N=20; 25) | 12 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19F Pre (N=22; 23) | 17 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19F Post (N=20; 21) | 20 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-7F Post (N=25; 26) | 25 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-23F Pre (N=21; 16) | 18 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6A Post (N=19; 19) | 14 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-23F Post (N=25; 25) | 25 subjects |
| Synflorix Booster Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-4 Pre (N=17; 19) | 7 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-23F Post (N=25; 25) | 25 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-7F Pre (N=17; 12) | 4 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-18C Post (N=26; 27) | 27 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19A Pre (N=18; 18) | 0 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19F Pre (N=22; 23) | 2 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-1 Pre (N=28; 25) | 1 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-1 Post (N=25; 25) | 13 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-4 Pre (N=17; 19) | 1 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-4 Post (N=24; 18) | 18 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-5 Pre (N=19; 23) | 1 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-5 Post (N=20; 25) | 21 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6A Pre (N=20; 25) | 2 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6A Post (N=19; 19) | 12 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6B Pre (N=22; 25) | 3 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-7F Post (N=25; 26) | 26 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-9V Pre (N=20; 17) | 11 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-9V Post (N=23; 23) | 22 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-14 Pre (N=16; 11) | 5 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-14 Post (N=21; 25) | 25 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-18C Pre (N=29; 28) | 3 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19A Post (N=23; 19) | 5 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-19F Post (N=20; 21) | 20 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-23F Pre (N=21; 16) | 8 subjects |
| Synflorix Catch-up Group | Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Opsono-6B Post (N=24; 27) | 13 subjects |
Secondary
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
Time frame: Before (pre) and one month after (post) the administration of Dose 2
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-23F Pre (N=76; 71) | 59 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-4 Pre (N=75; 73) | 45 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-4 Post (N=77; 70) | 77 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-5 Pre (N=76; 70) | 58 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19A Post (N=78; 70) | 78 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19F Pre (N=80; 72) | 76 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19F Post (N=78; 70) | 78 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-1 Post (N=78; 70) | 78 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-1 Pre (N=79; 72) | 43 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-5 Post (N=78; 70) | 77 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6A Pre (N=76; 72) | 66 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6A Post (N=77; 70) | 71 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6B Pre (N=76; 73) | 55 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6B Post (N=78; 70) | 76 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-7F Pre (N=70; 68) | 60 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-7F Post (N=78; 70) | 77 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-9V Pre (N=78; 72) | 71 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-9V Post (N=79; 70) | 79 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-14 Pre (N=76; 71) | 69 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-14 Post (N=79; 70) | 79 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-18C Pre (N=77; 73) | 68 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-18C Post (N=78; 70) | 78 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19A Pre (N=78; 73) | 72 subjects |
| Synflorix Booster Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-23F Post (N=78; 70) | 78 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-14 Post (N=79; 70) | 70 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-1 Post (N=78; 70) | 70 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6B Post (N=78; 70) | 59 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-4 Pre (N=75; 73) | 3 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19A Post (N=78; 70) | 70 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-4 Post (N=77; 70) | 70 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-7F Pre (N=70; 68) | 8 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6A Post (N=77; 70) | 64 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-18C Pre (N=77; 73) | 5 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-7F Post (N=78; 70) | 70 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19F Pre (N=80; 72) | 19 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19F Post (N=78; 70) | 70 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-9V Pre (N=78; 72) | 6 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-23F Post (N=78; 70) | 66 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-18C Post (N=78; 70) | 70 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-1 Pre (N=79; 72) | 1 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-5 Pre (N=76; 70) | 7 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-9V Post (N=79; 70) | 69 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-5 Post (N=78; 70) | 70 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-23F Pre (N=76; 71) | 3 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6A Pre (N=76; 72) | 36 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-14 Pre (N=76; 71) | 20 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-19A Pre (N=78; 73) | 50 subjects |
| Synflorix Catch-up Group | Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-6B Pre (N=76; 73) | 1 subjects |