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| ID | Type | Description | Link |
|---|---|---|---|
| 6115A1-3020 |
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The purpose of this study will be to assess the safety, tolerability, and immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50 years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | => 65 years of age |
|
| Group 2 | Experimental | 50 to 64 years of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaccine-13vPnC | Biological | Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination | Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5*limit of detection (LOD [8]) = (titer of 4) for the purpose of calculating the OPA GMT. | One month (28 to 42 days) after vaccination |
| Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination | Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters [cm]), Moderate (5.1 to 10.0 cm), Severe (>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity). | Within 14 days after vaccination |
| Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination | Systemic events reported using electronic diary. Fever-Any:>=38 degrees Celsius (C), Mild (M):>=38 to <38.5 degrees C, Moderate(Mod):>=38.5 to <39 degrees C, Severe (S):>=39 to <=40 degrees C, Potentially life threatening:>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:>=6/d. All reports of fever >40 degrees C were confirmed as data entry errors. | Within 14 days after vaccination |
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination | Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using microcolony OPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Mexicano de Investigación ClÃnica, S.A. de C.V | México | D.f. | 06700 | Mexico | ||
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25499011 | Derived | Tinoco JC, Juergens C, Ruiz Palacios GM, Vazquez-Narvaez J, Enkerlin-Pauwells HL, Sundaraiyer V, Pathirana S, Kalinina E, Gruber WC, Scott DA, Schmoele-Thoma B. Open-label trial of immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults >/= 50 years of age in Mexico. Clin Vaccine Immunol. 2015 Feb;22(2):185-92. doi: 10.1128/CVI.00711-14. Epub 2014 Dec 10. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC, Cohort 1 | Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1. |
| FG001 | 13vPnC, Cohort 2 | Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC, Cohort 1 | Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1. |
| BG001 | 13vPnC, Cohort 2 |
| 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 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination | Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5*limit of detection (LOD [8]) = (titer of 4) for the purpose of calculating the OPA GMT. | Evaluable Immunogenicity Population (EIP): eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month (28 to 42 days) after vaccination |
|
Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 post 13vPnC.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 13vPnC, Cohort 1 | Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| vaccine-13vPnC | Biological | Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1) |
|
|
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state. |
| Baseline up to 1 Month (28 to 42 days) after vaccination |
| One month (28 to 42 days) after vaccination |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination | Geometric mean fold rises (GMFRs) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from pre-vaccination to 1 month post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. | Pre-vaccination to 1 month (28 to 42 days) after vaccination |
| Mexico City |
| Mexico City |
| 14000 |
| Mexico |
| Star Medica | Morelia | Michoacán | CP 58070 | Mexico |
| Hospital General de Durango | Durango | 34000 | Mexico |
Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| 13vPnC, Cohort 1 |
Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1. |
| OG001 | 13vPnC, Cohort 2 | Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1. |
|
|
| Primary | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination | Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters [cm]), Moderate (5.1 to 10.0 cm), Severe (>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity). | Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified local reaction for each group respectively. Participants may be represented in >1 category. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 14 days after vaccination |
|
|
|
| Primary | Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination | Systemic events reported using electronic diary. Fever-Any:>=38 degrees Celsius (C), Mild (M):>=38 to <38.5 degrees C, Moderate(Mod):>=38.5 to <39 degrees C, Severe (S):>=39 to <=40 degrees C, Potentially life threatening:>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:>=6/d. All reports of fever >40 degrees C were confirmed as data entry errors. | Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified systemic event for each group respectively. Participants may be represented in >1 category. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 14 days after vaccination |
|
|
|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state. | Safety Population included all participants who received the vaccine. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 1 Month (28 to 42 days) after vaccination |
|
|
|
| Secondary | Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination | Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using microcolony OPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13. | EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations. | Posted | Number | 95% Confidence Interval | percentage of participants | One month (28 to 42 days) after vaccination |
|
|
|
| Secondary | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination | Geometric mean fold rises (GMFRs) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from pre-vaccination to 1 month post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. | EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result, received no prohibited vaccines, and had no other major protocol violations. Here "N" signifies participants with valid and determinate assay results at both pre-vaccination and post-vaccination. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Pre-vaccination to 1 month (28 to 42 days) after vaccination |
|
|
|
| 0 |
| 162 |
| 119 |
| 162 |
| EG001 | 13vPnC, Cohort 2 | Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1. | 2 | 161 | 88 | 161 |
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Fever Any | General disorders | Systemic Events | Systematic Assessment |
|
| Fever Mild | General disorders | Systemic Events | Systematic Assessment |
|
| Fever Moderate | General disorders | Systemic Events | Systematic Assessment |
|
| Fever Severe | General disorders | Systemic Events | Systematic Assessment |
|
| Fever Potentially life threatening | General disorders | Systemic Events | Systematic Assessment | All 'Fever Potentially life threatening' events were confirmed as data entry errors. |
|
| Fatigue Any | General disorders | Systemic Events | Systematic Assessment |
|
| Fatigue Mild | General disorders | Systemic Events | Systematic Assessment |
|
| Fatigue Moderate | General disorders | Systemic Events | Systematic Assessment |
|
| Fatigue Severe | General disorders | Systemic Events | Systematic Assessment |
|
| Headache Any | General disorders | Systemic Events | Systematic Assessment |
|
| Headache Mild | General disorders | Systemic Events | Systematic Assessment |
|
| Headache Moderate | General disorders | Systemic Events | Systematic Assessment |
|
| Headache Severe | General disorders | Systemic Events | Systematic Assessment |
|
| Vomiting Any | General disorders | Systemic Events | Systematic Assessment |
|
| Vomiting Mild | General disorders | Systemic Events | Systematic Assessment |
|
| Vomiting Moderate | General disorders | Systemic Events | Systematic Assessment |
|
| Vomiting Severe | General disorders | Systemic Events | Systematic Assessment |
|
| Diarrhea Any | General disorders | Systemic Events | Systematic Assessment |
|
| Diarrhea Mild | General disorders | Systemic Events | Systematic Assessment |
|
| Diarrhea Moderate | General disorders | Systemic Events | Systematic Assessment |
|
| Diarrhea Severe | General disorders | Systemic Events | Systematic Assessment |
|
| Muscle pain Any | General disorders | Systemic Events | Systematic Assessment |
|
| Muscle pain Mild | General disorders | Systemic Events | Systematic Assessment |
|
| Muscle pain Moderate | General disorders | Systemic Events | Systematic Assessment |
|
| Muscle pain Severe | General disorders | Systemic Events | Systematic Assessment |
|
| Joint pain Any | General disorders | Systemic Events | Systematic Assessment |
|
| Joint pain Mild | General disorders | Systemic Events | Systematic Assessment |
|
| Joint pain Moderate | General disorders | Systemic Events | Systematic Assessment |
|
| Joint pain Severe | General disorders | Systemic Events | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Urethral pain | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Redness Any | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Redness Mild | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Redness Moderate | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Redness Severe | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Swelling Any | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Swelling Mild | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Swelling Moderate | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Swelling Severe | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Pain at injection site Any | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Pain at injection site Mild | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Pain at injection site Moderate | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Pain at injection site Severe | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D007239 | Infections |
| Redness: Moderate (n=125, 115) |
|
| Redness: Severe (n=125, 112) |
|
| Swelling: Any (n=130, 120) |
|
| Swelling: Mild (n=127, 120) |
|
| Swelling: Moderate (n=127, 114) |
|
| Swelling: Severe (n=125, 113) |
|
| Pain at injection site: Any (n=151, 137) |
|
| Pain at injection site: Mild (n=151, 136) |
|
| Pain at injection site: Moderate (n=130, 117) |
|
| Pain at injection site: Severe (n=125, 113) |
|
| Fever: Moderate (n=125, 113) |
|
| Fever: Severe (n=124, 113) |
|
| Fever: Potentially life threatening (n=124, 116) |
|
| Fatigue: Any (n=144, 132) |
|
| Fatigue: Mild (n=142, 130) |
|
| Fatigue: Moderate (n=134, 125) |
|
| Fatigue: Severe (n=126, 113) |
|
| Headache: Any (n=140, 129) |
|
| Headache: Mild (n=140, 128) |
|
| Headache: Moderate (n=129, 119) |
|
| Headache: Severe (n=126, 115) |
|
| Vomiting: Any (n=125, 113) |
|
| Vomiting: Mild (n=125, 113) |
|
| Vomiting: Moderate (n=124, 113) |
|
| Vomiting: Severe (n=124, 112) |
|
| Diarrhea: Any (n=134, 120) |
|
| Diarrhea: Mild (n=129, 120) |
|
| Diarrhea: Moderate (n=129, 113) |
|
| Diarrhea: Severe (n=125, 112) |
|
| Muscle pain: Any (n=147, 132) |
|
| Muscle pain: Mild (n=146, 129) |
|
| Muscle pain: Moderate (n=132, 123) |
|
| Muscle pain: Severe (n=125, 116) |
|
| Joint pain: Any (n=139, 129) |
|
| Joint pain: Mild (n=137, 127) |
|
| Joint pain: Moderate (n=130, 123) |
|
| Joint pain: Severe (n=125, 116) |
|
| Use of medication to treat fever (n=129, 118) |
|
| Use of medication to treat pain (n=130, 121) |
|
| 4 |
|
| 5 |
|
| 6A |
|
| 6B |
|
| 7F |
|
| 9V |
|
| 14 |
|
| 18C |
|
| 19A |
|
| 19F |
|
| 23F |
|
| 4 |
|
| 5 |
|
| 6A |
|
| 6B |
|
| 7F |
|
| 9V |
|
| 14 |
|
| 18C |
|
| 19A |
|
| 19F |
|
| 23F |
|