Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Conditions
Keywords
Primary vaccination, Safety, Pneumococcal vaccine., Pneumococcal disease, Immunogenicity
Brief summary
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Mexican infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine (Infanrix hexa) and rotavirus vaccine (Rotarix) in children during the first 6 months of age.
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALSynflorix
Intramuscular injection, 3 doses.
BIOLOGICALInfanrix hexa
Intramuscular injection, 3 doses.
BIOLOGICALRotarix
Oral, 2 doses.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects between and including 6-12 weeks of age at the time of the first vaccination. * 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. * Born after a gestation period of 36 to 42 weeks inclusive.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month after dose 3. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * A family history of congenital or hereditary immunodeficiency. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae; with the exception of vaccines where the first dose may be given at birth within the first two weeks of life according to national recommendations (e.g. Hepatitis B and BCG). * History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b disease. * Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). * Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of any neurological disorders or seizures. * Major congenital defects or serious chronic illness. * Acute disease at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Concentrations Against Pneumococcal Vaccine Serotypes | One month after the administration of the 3rd vaccine dose i.e. Month 5 | Concentrations were expressed as geometric mean concentration (GMC). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. |
| Antibody Concentrations Against Protein D | One month after the administration of the 3rd vaccine dose i.e. Month 5 | Concentrations were given as geometric mean concentration (GMC) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter | One month after the administration of the 3rd vaccine dose i.e. Month 5 | The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. |
| Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes | One month after the administration of the 3rd vaccine dose i.e. Month 5 | Antibody concentrations were expressed as Geometric Mean Concentrations against pneumococcal cross-reactive serotypes 6A and 19A. |
| Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes | One month after the administration of the 3rd vaccine dose i.e. Month 5 | The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cross-reactive pneumococcal serotypes assessed include 6A and 19A. |
| Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes | One month after the administration of the 3rd vaccine dose i.e. Month 5 | Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. |
| Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes | One month after the administration of the 3rd vaccine dose i.e. Month 5 | Seropositivity was defined as an opsonic titer greater than or equal to 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. |
| Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes | One month after the administration of the 3rd vaccine dose i.e. Month 5 | Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The cross-reactive pneumococcal serotypes assessed include 6A and 19A. |
| Number of Subjects Seropositive for Anti-Protein D Antibodies | One month after the administration of the 3rd vaccine dose i.e. Month 5 | Seropositivity was defined as antibody concentration greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Within 4 days following any vaccine dose | Grade 3 redness and swelling was \> 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of grade and whatever the number of injections. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Within 4 days following any vaccine dose | Any fever was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 fever was axillary temperature \> 39.5°C. Grade 3 drowsiness, irritability, and loss of appetite was general symptom which prevented normal everyday activities. Grade 3 diarrhea was ≥ 6 looser than normal stools/day and Grade 3 vomiting was ≥ 3 episodes of vomiting/day. Related was solicited general symptom considered by the investigator to have a causal relationship to study vaccination. |
| Number of Subjects Reporting Any Unsolicited AEs | Within 31 days after any vaccine dose | Unsolicited AE covers any AE 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. |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | Up to Month 5 | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes | One month after the administration of the 3rd vaccine dose i.e. Month 5 | Seropositivity was defined as anti-pneumococcal antibody opsonic titer greater than or equal to 8. The vaccine pneumococcal cross-reactive serotypes assessed include 6A and 19A. |
| Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes | One month after the administration of the 3rd vaccine dose i.e. Month 5 | The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Synflorix Vaccine Group Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age. | 230 |
| Total | 230 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Synflorix Vaccine Group |
|---|---|
| Age, Continuous | 8.2 weeks STANDARD_DEVIATION 1.63 |
| Sex: Female, Male Female | 123 Participants |
| Sex: Female, Male Male | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 229 / 230 |
| serious Total, serious adverse events | 15 / 230 |
Outcome results
Primary
Antibody Concentrations Against Pneumococcal Vaccine Serotypes
Concentrations were expressed as geometric mean concentration (GMC). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Vaccine Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes | Anti-1 antibody (N=219) | 2.13 microgram per milliliter |
| Synflorix Vaccine Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes | Anti-4 antibody (N=218) | 3.04 microgram per milliliter |
| Synflorix Vaccine Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes | Anti-5 antibody (N=218) | 3.24 microgram per milliliter |
| Synflorix Vaccine Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes | Anti-6B antibody (N=218) | 1.32 microgram per milliliter |
| Synflorix Vaccine Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes | Anti-7F antibody (N=218) | 3.72 microgram per milliliter |
| Synflorix Vaccine Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes | Anti-9V antibody (N=218) | 3.71 microgram per milliliter |
| Synflorix Vaccine Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes | Anti-14 antibody (N=218) | 5.27 microgram per milliliter |
| Synflorix Vaccine Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes | Anti-18C antibody (N=219) | 6.05 microgram per milliliter |
| Synflorix Vaccine Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes | Anti-19F antibody (N=219) | 5.49 microgram per milliliter |
| Synflorix Vaccine Group | Antibody Concentrations Against Pneumococcal Vaccine Serotypes | Anti-23F antibody (N=218) | 2.00 microgram per milliliter |
Primary
Antibody Concentrations Against Protein D
Concentrations were given as geometric mean concentration (GMC) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter.
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix Vaccine Group | Antibody Concentrations Against Protein D | 2923.2 ELISA units per milliliter |
Secondary
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes
Antibody concentrations were expressed as Geometric Mean Concentrations against pneumococcal cross-reactive serotypes 6A and 19A.
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Vaccine Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes | Anti-6A antibody | 0.28 microgram per milliliter |
| Synflorix Vaccine Group | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes | Anti-19A antibody | 0.26 microgram per milliliter |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 redness and swelling was \> 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of grade and whatever the number of injections.
Time frame: Within 4 days following any vaccine dose
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 196 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 80 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 91 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 0 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 178 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 10 subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any fever was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 fever was axillary temperature \> 39.5°C. Grade 3 drowsiness, irritability, and loss of appetite was general symptom which prevented normal everyday activities. Grade 3 diarrhea was ≥ 6 looser than normal stools/day and Grade 3 vomiting was ≥ 3 episodes of vomiting/day. Related was solicited general symptom considered by the investigator to have a causal relationship to study vaccination.
Time frame: Within 4 days following any vaccine dose
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fever | 0 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fever | 147 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any drowsiness | 156 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 drowsiness | 7 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related drowsiness | 153 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fever | 147 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any irritability | 198 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 irritability | 21 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related irritability | 196 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any loss of appetite | 113 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 loss of appetite | 1 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related loss of appetite | 111 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any vomiting | 56 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 vomiting | 7 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related vomiting | 56 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any diarrhea | 55 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 diarrhea | 5 subjects |
| Synflorix Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related diarrhea | 55 subjects |
Secondary
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Up to Month 5
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Vaccine Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 15 subjects |
Secondary
Number of Subjects Reporting Any Unsolicited AEs
Unsolicited AE covers any AE 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.
Time frame: Within 31 days after any vaccine dose
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Vaccine Group | Number of Subjects Reporting Any Unsolicited AEs | 174 subjects |
Secondary
Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes
Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Vaccine Group | Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes | Anti-6A antibody | 203 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes | Anti-19A antibody | 198 subjects |
Secondary
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes
Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Vaccine Group | Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes | Anti-1 antibody (N=219) | 219 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes | Anti-4 antibody (N=218) | 218 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes | Anti-5 antibody (N=218) | 218 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes | Anti-6B antibody (N=218) | 212 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes | Anti-7F antibody (N=218) | 218 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes | Anti-9V antibody (N=218) | 218 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes | Anti-14 antibody (N=218) | 218 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes | Anti-18C antibody (N=219) | 218 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes | Anti-19F antibody (N=219) | 219 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes | Anti-23F antibody (N=218) | 212 subjects |
Secondary
Number of Subjects Seropositive for Anti-Protein D Antibodies
Seropositivity was defined as antibody concentration greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter.
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix Vaccine Group | Number of Subjects Seropositive for Anti-Protein D Antibodies | 219 subjects |
Secondary
Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes
Seropositivity was defined as anti-pneumococcal antibody opsonic titer greater than or equal to 8. The vaccine pneumococcal cross-reactive serotypes assessed include 6A and 19A.
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Vaccine Group | Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes | Opsono-6A titer (N=91) | 69 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes | Opsono-19A titer (N=81) | 19 subjects |
Secondary
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes
Seropositivity was defined as an opsonic titer greater than or equal to 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Vaccine Group | Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes | Opsono-1 titer (N=97) | 83 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes | Opsono-4 titer (N=97) | 93 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes | Opsono-5 titer (N=94) | 93 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes | Opsono-6B titer (N=96) | 76 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes | Opsono-7F titer (N=96) | 96 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes | Opsono-9V titer (N=96) | 96 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes | Opsono-14 titer (N=94) | 93 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes | Opsono-18C titer (N=94) | 91 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes | Opsono-19F titer (N=92) | 90 subjects |
| Synflorix Vaccine Group | Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes | Opsono-23F titer (N=95) | 90 subjects |
Secondary
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix Vaccine Group | Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter | Anti-19F antibody (N=219) | 217 subjects |
| Synflorix Vaccine Group | Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter | Anti-1 antibody (N=219) | 219 subjects |
| Synflorix Vaccine Group | Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter | Anti-4 antibody (N=218) | 218 subjects |
| Synflorix Vaccine Group | Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter | Anti-5 antibody (N=218) | 218 subjects |
| Synflorix Vaccine Group | Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter | Anti-6B antibody (N=218) | 203 subjects |
| Synflorix Vaccine Group | Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter | Anti-7F antibody (N=218) | 218 subjects |
| Synflorix Vaccine Group | Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter | Anti-9V antibody (N=218) | 218 subjects |
| Synflorix Vaccine Group | Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter | Anti-14 antibody (N=218) | 216 subjects |
| Synflorix Vaccine Group | Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter | Anti-18C antibody (N=219) | 218 subjects |
| Synflorix Vaccine Group | Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter | Anti-23F antibody (N=218) | 207 subjects |
Secondary
Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes
The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Vaccine Group | Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes | Opsono-6A titer (N=91) | 159.2 titer |
| Synflorix Vaccine Group | Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes | Opsono-19A titer (N=81) | 11.6 titer |
Secondary
Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes
The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Vaccine Group | Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes | Opsono-1 titer (N=97) | 94.1 titer |
| Synflorix Vaccine Group | Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes | Opsono-4 titer (N=97) | 670.8 titer |
| Synflorix Vaccine Group | Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes | Opsono-5 titer (N=94) | 148.8 titer |
| Synflorix Vaccine Group | Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes | Opsono-6B titer (N=96) | 345.4 titer |
| Synflorix Vaccine Group | Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes | Opsono-7F titer (N=96) | 4435.4 titer |
| Synflorix Vaccine Group | Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes | Opsono-9V titer (N=96) | 1186.1 titer |
| Synflorix Vaccine Group | Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes | Opsono-14 titer (N=94) | 1168.3 titer |
| Synflorix Vaccine Group | Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes | Opsono-18C titer (N=94) | 222.9 titer |
| Synflorix Vaccine Group | Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes | Opsono-19F titer (N=92) | 589.2 titer |
| Synflorix Vaccine Group | Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes | Opsono-23F titer (N=95) | 1876.3 titer |