Trial · NCT04024228
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Day 28 post-vaccination | GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution. |
| Secondary | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution. |
| Secondary | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution. |
| Secondary | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). |
| Secondary | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). |
| Secondary | Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | Day 28 post-vaccination | Neutralizing Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of participants (all age group participants) with neutralizing antibody titers \>=40 (1/dilution) is reported in the outcome measure. |
| Secondary | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | Day 28 post-vaccination | Neutralizing Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of participants (aged 60-64 Years and \>=65 Years) with neutralizing antibody titers \>=40 (1/dilution) is reported in the outcome measure. |
| Secondary | Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens | Day 28 post-vaccination | Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 1:10 (1/dilution) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. Percentage of participants (all age group participants) achieving seroconversion is reported in the outcome measure. |
| Secondary | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | Day 28 post-vaccination | Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 (1/dilution) and a post-vaccination titer \>= 1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. Percentage of participants (aged 60-64 Years and \>=65 Years) achieving seroconversion is reported in the outcome measure. |
| Secondary | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes post-vaccination | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. |
| Secondary | Number of Participants Reporting Solicited Injection Site Reactions | Within 7 days post-vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included induration, bruising, pain, erythema, and swelling. |
| Secondary | Number of Participants Reporting Solicited Systemic Reactions | Within 7 days post-vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering. |
| Secondary | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Within 28 days post-vaccination | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. |
| Secondary | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | From Day 0 up to 6 months post-vaccination | A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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