Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001510-10 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synflorix Vaccine Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synflorix | Biological | Intramuscular injection, 3 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
| Antibody Concentrations Against Protein D | Concentrations were given as geometric mean concentration (GMC) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter. | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mexico City | 14000 | Mexico | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Ruiz-Palacios G et al. Immunogenicity, safety and reactogenicity of the new 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) in Mexican infants. Abstract presented at the XIII Congreso Latinoamericano de InfectologÃa Pediátrica (SLIPE). Guayaquil, Ecuador, 12-15 August 2009. | ||
| 22048109 | Background | Ruiz-Palacios GM, Guerrero ML, Hernandez-Delgado L, Lavalle-Villalobos A, Casas-Munoz A, Cervantes-Apolinar Y, Moreira M, Schuerman L. Immunogenicity, reactogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Mexican infants. Hum Vaccin. 2011 Nov;7(11):1137-45. doi: 10.4161/hv.7.11.17984. Epub 2011 Nov 1. | |
| Background | Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010. |
| 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 |
|---|---|---|---|
| 109661 | Statistical Analysis Plan | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below).
IPD is available via the Clinical Study Data Request site (click on the link provided below).
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | microgram per milliliter | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
|
Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Not provided
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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C547294 | PHiD-CV vaccine |
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| C492457 | RIX4414 vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Infanrix hexa | Biological | Intramuscular injection, 3 doses. |
|
| Rotarix | Biological | Oral, 2 doses. |
|
| 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. | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
| Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes | Antibody concentrations were expressed as Geometric Mean Concentrations against pneumococcal cross-reactive serotypes 6A and 19A. | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
| 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. | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
| 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. | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
| 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. | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
| 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. | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
| 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. | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
| 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. | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
| 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. | Within 4 days following any vaccine dose |
| 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. | Within 4 days following any vaccine dose |
| 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. | Within 31 days after any vaccine dose |
| 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. | Up to Month 5 |
| México |
| 14000 |
| Mexico |
| Background | Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010. |
| 26954689 | Background | Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109661 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109661 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109661 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109661 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109661 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | ELISA units per milliliter | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
|
|
|
| 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. | Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
|
|
|
| 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. | Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available. | Posted | Number | subjects | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
|
|
|
| Secondary | Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes | Antibody concentrations were expressed as Geometric Mean Concentrations against pneumococcal cross-reactive serotypes 6A and 19A. | Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | microgram per milliliter | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
|
|
|
| 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. | Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
|
|
|
| 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. | Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available. | Posted | Number | subjects | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
|
|
|
| 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. | Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available. | Posted | Number | subjects | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
|
|
|
| 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. | Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available. | Posted | Number | subjects | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
|
|
|
| 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. | Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available. | Posted | Number | subjects | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
|
|
|
| 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. | Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available. | Posted | Number | subjects | One month after the administration of the 3rd vaccine dose i.e. Month 5 |
|
|
|
| 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. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Number | subjects | Within 4 days following any vaccine dose |
|
|
|
| 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. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Number | subjects | Within 4 days following any vaccine dose |
|
|
|
| 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. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Number | subjects | Within 31 days after any vaccine dose |
|
|
|
| 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. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Number | subjects | Up to Month 5 |
|
|
|
| 15 |
| 230 |
| 229 |
| 230 |
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | Non-systematic Assessment |
|
| Herpangina | Infections and infestations | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia viral | Infections and infestations | Non-systematic Assessment |
|
| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Diarrhea | General disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Loss of appetite | General disorders | Systematic Assessment |
|
| Vomiting | General disorders | Systematic Assessment |
|
| Nasopharyngitis | General disorders | Non-systematic Assessment |
|
| Pharyngitis | General disorders | Non-systematic Assessment |
|
| Conjunctivitis | General disorders | Non-systematic Assessment |
|
| Cough | General disorders | Non-systematic Assessment |
|
| Gastroenteritis | General disorders | Non-systematic Assessment |
|
| Diarrhea | General disorders | Non-systematic Assessment |
|
| Laryngitis | General disorders | Non-systematic Assessment |
|
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.
|
| Opsono-6B titer (N=96) |
|
| Opsono-7F titer (N=96) |
|
| Opsono-9V titer (N=96) |
|
| Opsono-14 titer (N=94) |
|
| Opsono-18C titer (N=94) |
|
| Opsono-19F titer (N=92) |
|
| Opsono-23F titer (N=95) |
|
| Title | Measurements |
|---|---|
|
| Anti-6B antibody (N=218) |
|
| Anti-7F antibody (N=218) |
|
| Anti-9V antibody (N=218) |
|
| Anti-14 antibody (N=218) |
|
| Anti-18C antibody (N=219) |
|
| Anti-19F antibody (N=219) |
|
| Anti-23F antibody (N=218) |
|
| Title | Measurements |
|---|---|
|
| Anti-6B antibody (N=218) |
|
| Anti-7F antibody (N=218) |
|
| Anti-9V antibody (N=218) |
|
| Anti-14 antibody (N=218) |
|
| Anti-18C antibody (N=219) |
|
| Anti-19F antibody (N=219) |
|
| Anti-23F antibody (N=218) |
|
| Title | Measurements |
|---|---|
|
| Opsono-6B titer (N=96) |
|
| Opsono-7F titer (N=96) |
|
| Opsono-9V titer (N=96) |
|
| Opsono-14 titer (N=94) |
|
| Opsono-18C titer (N=94) |
|
| Opsono-19F titer (N=92) |
|
| Opsono-23F titer (N=95) |
|
| Title | Measurements |
|---|---|
|
| Grade 3 redness |
|
| Any swelling |
|
| Grade 3 swelling |
|
| Title | Measurements |
|---|---|
|
| Any drowsiness |
|
| Grade 3 drowsiness |
|
| Related drowsiness |
|
| Any fever |
|
| Grade 3 fever |
|
| Related fever |
|
| Any irritability |
|
| Grade 3 irritability |
|
| Related irritability |
|
| Any loss of appetite |
|
| Grade 3 loss of appetite |
|
| Related loss of appetite |
|
| Any vomiting |
|
| Grade 3 vomiting |
|
| Related vomiting |
|