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The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a more immunogenic and effective response compared with conventional influenza vaccines in elderly and adults.
The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children 6 to <72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted trivalent influenza vaccine (TIV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aTIV | Experimental | aTIV is a trivalent influenza virus vaccine, adjuvanted with MF59C. |
|
| TIV | Active Comparator | TIV is trivalent influenza vaccine licensed in Mexico. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29) | Biological | A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV, a trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, administered at day 1 (for all subjects) and day 29 (for naïve subjects). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Number of naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination. | From Day 1 to Day 7 by vaccination |
| Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Number of non-naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination. | From Day 1 to Day 7 |
| Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Number of naive subjects ≥ 36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination. | From Day 1 to Day 7 by vaccination |
| Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Number of non-naive subjects ≥36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination. | From Day 1 to Day 7 |
| Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | Number of naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50. | From Day 1 to Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer <10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable. |
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Inclusion Criteria:
Exclusion Criteria:
Progressive, unstable or uncontrolled clinical conditions.
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
History of progressive or severe neurologic disorder, seizure disorder or Guillain-Barré syndrome.
Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule.
Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Any fatal prognosis of an underlying medical condition (<12 month life expectancy).
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
Abnormal function of the immune system resulting from:
Received immunoglobulins or any blood products within 180 days prior to informed consent.
Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
Study personnel as an immediate family or household member.
Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Received any influenza vaccine (licensed or investigational) or with laboratory confirmed influenza within 6 months prior enrollment.
Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 03, Centro Médico Universitario | Colonia Chamilpa, Cuernavaca | Morelos | Mexico | |||
| 02, Unidad de Atencion Medica E Investigacion En Salud S.C (Unamis) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28925801 | Derived | Cruz-Valdez A, Valdez-Zapata G, Patel SS, Castelli FV, Garcia MG, Jansen WT, Arora AK, Heijnen E. MF59-adjuvanted influenza vaccine (FLUAD(R)) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone(R)): A randomized, multicenter, Phase III pediatric trial in Mexico. Hum Vaccin Immunother. 2018 Feb 1;14(2):386-395. doi: 10.1080/21645515.2017.1373227. Epub 2018 Jan 3. |
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All enrolled subjects were included in study.
Subjects were enrolled from 3 study centers in Mexico.
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| ID | Title | Description |
|---|---|---|
| FG000 | aTIV (6 Months to < 72 Months) | A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered. |
| FG001 | TIV (6 Months to < 72 Months) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Non-adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29). | Biological | A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV , an egg-derived trivalent split influenza vaccine licensed in Mexico, administered at day 1 (for all subjects) and day 29 (for naïve subjects) |
|
| Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | Number of non-naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22. | From Day 1 to Day 22 |
| Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age. The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007). | Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination |
| Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination |
| Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to <72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67. | Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination |
| Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age. | Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination |
| Mérida |
| Yucatán |
| Mexico |
| 04, Medical Care and Research S.A. de C.V. | Mérida | Yucatán | Mexico |
A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | aTIV (6 Months to < 72 Months) | A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered. |
| BG001 | TIV (6 Months to < 72 Months) | A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Months |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| 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 | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Number of naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination. | Analysis performed on the Solicited Safety Set. | Posted | Number | Participants | From Day 1 to Day 7 by vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Number of non-naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination. | Analysis performed on the Solicited Safety Set. | Posted | Number | Participants | From Day 1 to Day 7 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Number of naive subjects ≥ 36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination. | Analysis performed on the Solicited Safety Set. | Posted | Number | Participants | From Day 1 to Day 7 by vaccination |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Number of non-naive subjects ≥36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination. | Analysis performed on the Solicited Safety Set. | Posted | Number | Participants | From Day 1 to Day 7 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | Number of naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50. | Analysis performed on the Unsolicited Safety Set. | Posted | Number | Participants | From Day 1 to Day 50 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | Number of non-naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22. | Analysis performed on the Unsolicited Safety Set. | Posted | Number | Participants | From Day 1 to Day 22 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age. The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007). | Analysis performed on the Per Protocol Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination |
|
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| Secondary | Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer <10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable. | Analysis performed on the Per Protocol Set. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination |
|
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| Secondary | Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to <72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67. | Analysis performed on the Per Protocol Set. | Posted | Geometric Mean | 95% Confidence Interval | Ratios | Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination |
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| Secondary | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age. | Analysis performed on the Per Protocol Set. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination |
|
|
Throughout the study; Day 1 - Day 50 (naive subjects) and Day 1 - Day 22 (non-naive subjects).
Solicited AEs were collected by the subject parent(s)/legal guardian(s) for 7 days from the day of vaccination/s (Day 1 & Day 29 for naive; Day 1 for non-naive). Unsolicited AEs were collected from Day 1 to Day 50 for naive, from Day 1 to Day 22 for non-naive.
All AEs were monitored until resolution or the investigator assesses them as stable.
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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 | Naive_aTIV (6 Months to < 72 Months) | A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered (Naive). | 0 | 77 | 58 | 77 | ||
| EG001 | Naive_TIV (6 Months to < 72 Months) | A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered (Naive). Enrolled subjects- 79 Exposed subjects- 78 Reason for discrepancy- Before vaccination one subject was withdrawn from study because of the suspected egg allergy. | 0 | 78 | 52 | 78 | ||
| EG002 | Non-naive_aTIV (6 Months to < 72 Months) | A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered (Non-naive). | 0 | 67 | 35 | 67 | ||
| EG003 | Non-naive_TIV (6 Months to < 72 Months) | A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered (Non-naive). | 0 | 64 | 31 | 64 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Crying | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Injection site swelling | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Eating disorder | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| MALE |
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| Injection site ecchymosis (Vac-1, N= 65,69) |
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| Injection site ecchymosis (Vac-2, N= 66,67) |
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| Injection site induration (Vac-1, N= 66,69) |
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| Injection site induration (Vac-2, N= 66,67) |
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| Injection site swelling (Vac-1, N= 65,69) |
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| Injection site swelling (Vac-2, N= 66,67) |
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| Injection site erythema (Vac-1, N= 64,69) |
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| Injection site erythema (Vac-2, N= 66,67) |
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| Injection site tenderness (Vac-1, N= 66,69) |
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| Injection site tenderness (Vac-1, N= 66,66) |
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| Any Systemic (Vac-1) |
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| Any Systemic (Vac-2, N=67,67) |
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| Body Temperature (>=40°C) (Vac-1, N= 67,68) |
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| Body Temperature (>=40°C) (Vac-2, N= 67,67) |
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| Fever (Vac-1) |
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| Fever (Vac-2, N= 67,67) |
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| Change in eating habits (Vac-1, N= 67,69) |
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| Change in eating habits (Vac-2, N= 66,67) |
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| Diarrhea (Vac-1, N= 67,69) |
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| Diarrhea (Vac-2, N= 66,67) |
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| Irritability (Vac-1, N= 67,69) |
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| Irritability (Vac-2, N= 66,67) |
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| Persistent Crying (Vac-1, N= 67,69) |
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| Persistent Crying (Vac-2, N= 66,67) |
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| Sleepiness (Vac-1, N= 67,68) |
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| Sleepiness (Vac-2, N= 65,67) |
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| Vomiting (Vac-1, N= 67,68) |
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| Vomiting (Vac-2, N= 65,67) |
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| Prevention of Pain and or Fever (Vac-1, N= 67,67) |
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| Prevention of Pain and or Fever (Vac-2, N= 64,67) |
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| Treatment of Pain and or Fever (Vac-1, N= 67,67) |
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| Treatment of Pain and or Fever (Vac-1, N= 66,67) |
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