A Phase 4 interventional study of Fluzone Quadrivalent vaccine and Fluzone Quadrivalent vaccine in Influenza and Flu, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 3 sites in United States. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 4, Interventional, and Prevention
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Among 139 studies in Influenza, Human by Sanofi — 4 open to participants now, 6 under way, 1 of them phase 3. Influenza, Human · Sanofi.
Among the 139 studies in Influenza, Human by Sanofi, this one is the 73rd largest by enrollment of the 126 interventional ones that give a count, is one of 5 that started in 2017, is one of 33 in phase 4, and was the 88th registered.
2,358 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
Browse Influenza, Human studies →4 of the 139 studies in Influenza, Human by Sanofi are open now, in 3 countries. Recruiting first, the newest first:
Sanofi · Sites in Poland
Ages 60+ · Healthy volunteers
Sanofi · Sites in Korea, Republic of
Ages 65+ · Healthy volunteers
Sanofi · Sites in United States
Ages 18+ · Healthy volunteers
Sanofi · Sites in Korea, Republic of
Ages 65+ · Healthy volunteers
By country, each count listing its studies:
Of the 121 Influenza, Human studies recruiting now, 66 (55%) set no upper age limit and 45 (37%) stop at 75 or younger; 33 take children under 18; 67 take healthy volunteers.
This study: 6 Months and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
139 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 47 · Phase 3 35 · Phase 4 33
First in 2003; this study’s year is marked. 5 started in 2017.
This study's enrollment of 240 is close to the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Median enrollment 305 across the 126 interventional studies, 1,001 across the 13 observational. Of the 133 that completed or were terminated, 73 (55%) have results posted.
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This study is registered under Sanofi Pasteur, a Sanofi Company, one of the names counted as Sanofi. Under that name alone:
Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
2 of the studies in Influenza, Human by Sanofi that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06907511SanofiStudy to Evaluate the Safety and the Immunogenicity of a Second Generation Structurally Designed mRNA Vaccine Candidate Against Pandemic Influenza H5 HA Strain in Healthy Adult Participants Aged 18 Years and Older | 2026-12-01 |
| NCT07516418SanofiStudy of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age | 2027-04-04 |
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Among the 139 studies in Influenza, Human by Sanofi, from their registry updates:
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The aim of the study was to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Quadrivalent vaccine in children 6 months to \< 9 years of age, and in adults 18 to \< 65 years of age, and to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
All participants received 1 intramuscular dose of their assigned vaccine during Visit 1. For participants, for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of the same volume as the first dose was administered during Visit 2 (28 days after Visit 1). Solicited adverse reaction (AR) information was collected for 7 days following each vaccination. Unsolicited non-serious adverse event (AE) and serious adverse event (SAE) information was collected from Visit 1 to Visit 2 or from Visit 1 to Visit 3 for those participants receiving 2 doses of study vaccine.
Immunogenicity was evaluated in all participants prior to vaccination on Day 0 (Visit 1) and after the final vaccination (Day 28 post-final vaccination for participants 6 months to \< 9 years of age and Day 21 post-vaccination for participants ≥ 18 years of age).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children aged 6 to \< 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Biological: Fluzone Quadrivalent vaccine
Children aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Biological: Fluzone Quadrivalent vaccine
Adults aged 18 to \< 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Biological: Fluzone Quadrivalent vaccine
Adults aged \>= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Biological: Fluzone High-Dose vaccine
0.25 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months)
Solicited injection site reactions: Pain, Erythema and Swelling (Grade 3: Pain: cries when injected limb moved/ limb movement reduced, erythema and swelling \>= 50 mm). Solicited systemic reactions: Fever, vomiting, abnormal crying, drowsiness, appetite lost, Irritability (Grade 3: Fever: \>= 39.5 degrees Celsius \[103.1 degree Fahrenheit {°F}\], vomiting \>= six episodes per 24 hours, abnormal crying : \> 3 hours, drowsiness: sleeping most of the time or difficult to wake up, appetite lost: refuses \>= 3 feeds/meals or refuses most feeds/meals, Irritability: Inconsolable).
Time frame: Within 7 days after any vaccination
Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years)
Solicited injection site reactions: Pain (Group 2: Grade 3: Incapacitating; Group 3 and 4: Grade 3: significant; prevents daily activity), erythema \& swelling (Group 2: Grade 3: \>= 50 mm, Group 3 and 4: Grade 3: \> 100 mm). Solicited systemic reactions: Fever (Grade 3: \>= 39.0 degrees Celsius \[102.2°F\]), headache, malaise \& myalgia (Grade 3: significant interference with daily activities).
Time frame: Within 7 days after any vaccination
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Anti-influenza antibodies were measured using the hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage.
Time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4).
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage, measured using the HAI assay.
Time frame: Day 0 (pre-vaccination) and Day 28 (post-final vaccination)
GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4), measured using the HAI assay.
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer \>=40 (1/ dilution) at pre-vaccination or at post-final vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroprotection was defined as antibody titer \>= 40 (1/ dilution) at pre-vaccination or at post-final vaccination.
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-final vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-final vaccination titer.
Time frame: Day 0 (pre-vaccination) and Day 28 (post-final vaccination)
Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-final vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-final vaccination titer.
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Study participants were enrolled in 3 centers in the United States from 11 September 2017 to 25 October 2017.
| Milestone | Group 1: 6 to < 36 Months | Group 2: 3 to < 9 Years | Group 3: 18 to < 65 Years | Group 4: >= 65 Years |
|---|---|---|---|---|
| Started | 59 | 61 | 60 | 60 |
| Completed | 57 | 57 | 59 | 60 |
| Not completed | 2 | 4 | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 2 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 2 | 0 | 0 |
Solicited injection site reactions: Pain, Erythema and Swelling (Grade 3: Pain: cries when injected limb moved/ limb movement reduced, erythema and swelling \>= 50 mm). Solicited systemic reactions: Fever, vomiting, abnormal crying, drowsiness, appetite lost, Irritability (Grade 3: Fever: \>= 39.5 degrees Celsius \[103.1 degree Fahrenheit {°F}\], vomiting \>= six episodes per 24 hours, abnormal crying : \> 3 hours, drowsiness: sleeping most of the time or difficult to wake up, appetite lost: refuses \>= 3 feeds/meals or refuses most feeds/meals, Irritability: Inconsolable).
| Participants | Group 1: 6 to < 36 Months |
|---|---|
| Tenderness | 16 |
| Tenderness : Grade 3 | 1 |
| Erythema | 4 |
| Erythema : Grade 3 | 0 |
| Swelling | 2 |
| Swelling : Grade 3 | 0 |
| Fever | 6 |
| Fever : Grade 3 | 0 |
| Vomiting | 2 |
| Vomiting : Grade 3 | 0 |
| Crying Abnormal | 10 |
| Crying Abnormal : Grade 3 | 0 |
| Drowsiness | 11 |
| Drowsiness : Grade 3 | 0 |
| Appetite Lost | 7 |
| Appetite Lost : Grade 3 | 0 |
| Irritability | 13 |
| Irritability : Grade 3 | 0 |
Solicited injection site reactions: Pain (Group 2: Grade 3: Incapacitating; Group 3 and 4: Grade 3: significant; prevents daily activity), erythema \& swelling (Group 2: Grade 3: \>= 50 mm, Group 3 and 4: Grade 3: \> 100 mm). Solicited systemic reactions: Fever (Grade 3: \>= 39.0 degrees Celsius \[102.2°F\]), headache, malaise \& myalgia (Grade 3: significant interference with daily activities).
| Participants | Group 2: 3 to < 9 Years | Group 3: 18 to < 65 Years | Group 4: >= 65 Years |
|---|---|---|---|
| Pain | 25 | 27 | 20 |
| Pain: Grade 3 | 1 | 1 | 0 |
| Erythema | 9 | 0 | 3 |
| Erythema : Grade 3 | 3 | 0 | 0 |
| Swelling | 11 | 1 | 2 |
| Swelling : Grade 3 | 2 | 0 | 0 |
| Fever | 1 | 0 | 1 |
| Fever : Grade 3 | 1 | 0 | 1 |
| Headache | 2 | 10 | 6 |
| Headache : Grade 3 | 0 | 1 | 0 |
| Malaise | 3 | 5 | 9 |
| Malaise: Grade 3 | 1 | 1 | 0 |
| Myalgia | 11 | 13 | 17 |
| Myalgia : Grade 3 | 0 | 1 | 1 |
Anti-influenza antibodies were measured using the hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage.
| Titers (1/dilutions) | Group 1: 6 to < 36 Months | Group 2: 3 to < 9 Years |
|---|---|---|
| Pre-Vaccination: A/H1N1 | 19.9 (11.9 to 33.1) | 306 (198 to 473) |
| Pre-Vaccination: A/H3N2 | 49.7 (27.7 to 89.2) | 415 (253 to 681) |
| Pre-Vaccination: B Victoria | 32.0 (19.7 to 52.0) | 180 (112 to 290) |
| Pre-Vaccination: B Yamagata | 43.5 (27.6 to 68.5) | 334 (219 to 510) |
| Post-Final Vaccination: A/H1N1 | 450 (301 to 671) | 1606 (1198 to 2153) |
| Post-Final Vaccination: A/H3N2 | 568 (336 to 958) | 2370 (1712 to 3282) |
| Post-Final Vaccination: B Victoria | 481 (313 to 738) | 1668 (1142 to 2436) |
| Post-Final Vaccination: B Yamagata | 698 (465 to 1047) | 2187 (1610 to 2971) |
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4).
| Titers (1/dilutions) | Group 3: 18 to < 65 Years | Group 4: >= 65 Years |
|---|---|---|
| Pre-Vaccination: A/H1N1 | 165 (110 to 248) | 74.6 (52.3 to 106) |
| Pre-Vaccination: A/H3N2 | 231 (150 to 356) | 194 (130 to 291) |
| Pre-Vaccination: B Victoria | 276 (185 to 412) | 215 (151 to 305) |
| Pre-Vaccination: B Yamagata | 425 (308 to 587) | — |
| Post-Final Vaccination: A/H1N1 | 756 (539 to 1062) | 393 (275 to 561) |
| Post-Final Vaccination: A/H3N2 | 1128 (791 to 1610) | 864 (612 to 1218) |
| Post-Final Vaccination: B Victoria | 1117 (853 to 1463) | 644 (465 to 892) |
| Post-Final Vaccination: B Yamagata | 1312 (1010 to 1704) | — |
GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage, measured using the HAI assay.
| Titer Ratio | Group 1: 6 to < 36 Months | Group 2: 3 to < 9 Years |
|---|---|---|
| A/H1N1 | 17.6 (12.1 to 25.6) | 5.05 (3.56 to 7.16) |
| A/H3N2 | 10.8 (7.54 to 15.4) | 5.54 (3.67 to 8.37) |
| B Victoria | 13.1 (8.86 to 19.3) | 9.02 (6.06 to 13.4) |
| B Yamagata | 14.0 (9.44 to 20.8) | 6.46 (4.70 to 8.88) |
GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4), measured using the HAI assay.
| Titer Ratio | Group 3: 18 to < 65 Years | Group 4: Adults >= 65 Years |
|---|---|---|
| A/H1N1 | 4.31 (2.91 to 6.40) | 5.15 (3.50 to 7.57) |
| A/H3N2 | 4.44 (2.88 to 6.85) | 4.45 (3.09 to 6.40) |
| B Victoria | 4.05 (2.55 to 6.43) | 2.96 (2.26 to 3.88) |
| B Yamagata | 3.09 (2.16 to 4.42) | — |
Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer \>=40 (1/ dilution) at pre-vaccination or at post-final vaccination.
| Participants | Group 1: 6 to < 36 Months | Group 2: 3 to < 9 Years |
|---|---|---|
| Pre-Vaccination: A/H1N1 | 15 | 48 |
| Pre-Vaccination: A/H3N2 | 24 | 46 |
| Pre-Vaccination: B Victoria | 21 | 44 |
| Pre-Vaccination: B Yamagata | 31 | 50 |
| Post-Final Vaccination: A/H1N1 | 51 | 54 |
| Post-Final Vaccination: A/H3N2 | 50 | 54 |
| Post-Final Vaccination: B Victoria | 50 | 54 |
| Post-Final Vaccination: B Yamagata | 50 | 55 |
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroprotection was defined as antibody titer \>= 40 (1/ dilution) at pre-vaccination or at post-final vaccination.
| Participants | Group 3: 18 to < 65 Years | Group 4: >= 65 Years |
|---|---|---|
| Pre-Vaccination: A/H1N1 | 45 | 40 |
| Pre-Vaccination: A/H3N2 | 48 | 49 |
| Pre-Vaccination: B Victoria | 48 | 55 |
| Pre-Vaccination: B Yamagata | 54 | — |
| Post-Final Vaccination: A/H1N1 | 55 | 57 |
| Post-Final Vaccination: A/H3N2 | 55 | 59 |
| Post-Final Vaccination: B Victoria | 56 | 58 |
| Post-Final Vaccination: B Yamagata | 56 | — |
Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-final vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-final vaccination titer.
| Participants | Group 1: 6 to < 36 Months | Group 2: 3 to < 9 Years |
|---|---|---|
| A/H1N1 | 45 | 28 |
| A/H3N2 | 42 | 30 |
| B Victoria | 44 | 39 |
| B Yamagata | 46 | 36 |
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-final vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-final vaccination titer.
| Participants | Group 3: 18 to < 65 Years | Group 4: >= 65 Years |
|---|---|---|
| A/H1N1 | 26 | 33 |
| A/H3N2 | 22 | 33 |
| B Victoria | 19 | 18 |
| B Yamagata | 22 | — |
Collected over Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Groups 1 and 2; up to Day 21 for Groups 3 and 4.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: 6 to < 36 Months | 0/59 (0%) | 0/59 (0%) | 30/59 (50.8%) |
| Group 2: 3 to < 9 Years | 0/61 (0%) | 0/61 (0%) | 30/61 (49.2%) |
| Group 3: 18 to < 65 Years | 0/60 (0%) | 2/60 (3.3%) | 29/60 (48.3%) |
| Group 4: >= 65 Years | 0/60 (0%) | 0/60 (0%) | 30/60 (50%) |
| Event | Group 1: 6 to < 36 Months | Group 2: 3 to < 9 Years | Group 3: 18 to < 65 Years | Group 4: >= 65 Years |
|---|---|---|---|---|
| Abortion SpontaneousPregnancy, puerperium and perinatal conditions | 0/59 | 0/61 | 1/60 | 0/60 |
| AnxietyPsychiatric disorders | 0/59 | 0/61 | 1/60 | 0/60 |
| DepressionPsychiatric disorders | 0/59 | 0/61 | 1/60 | 0/60 |
| Event | Group 1: 6 to < 36 Months | Group 2: 3 to < 9 Years | Group 3: 18 to < 65 Years | Group 4: >= 65 Years |
|---|---|---|---|---|
| Injection Site PainGeneral disorders | 16/59 | 26/61 | 27/60 | 20/60 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/59 | 11/61 | 13/60 | 17/60 |
| IrritabilityPsychiatric disorders | 13/59 | 1/61 | 0/60 | 0/60 |
| SomnolenceNervous system disorders | 11/59 | 1/61 | 0/60 | 0/60 |
| Injection Site SwellingGeneral disorders | 2/59 | 11/61 | 1/60 | 2/60 |
| CryingGeneral disorders | 10/59 | 1/61 | 0/60 | 0/60 |
| HeadacheNervous system disorders | 1/59 | 2/61 | 10/60 | 7/60 |
| MalaiseGeneral disorders | 0/59 | 3/61 | 5/60 | 9/60 |
| Injection Site ErythemaGeneral disorders | 4/59 | 9/61 | 0/60 | 3/60 |
| PyrexiaGeneral disorders | 8/59 | 2/61 | 0/60 | 1/60 |
Safety Analysis set included all participants who received at least 1 dose of study vaccine, according to the vaccine they actually received.
| Age, Categorical(Participants) | Group 1: 6 to < 36 Months | Group 2: 3 to < 9 Years | Group 3: 18 to < 65 Years | Group 4: >= 65 Years | Total |
|---|---|---|---|---|---|
| <=18 years | 59 | 61 | 1 | 0 | 121 |
| Between 18 and 65 years | 0 | 0 | 59 | 0 | 59 |
| >=65 years | 0 | 0 | 0 | 60 | 60 |
| Sex: Female, Male(Participants) | Group 1: 6 to < 36 Months | Group 2: 3 to < 9 Years | Group 3: 18 to < 65 Years | Group 4: >= 65 Years | Total |
|---|---|---|---|---|---|
| Female | 25 | 31 | 46 | 39 | 141 |
| Male | 34 | 30 | 14 | 21 | 99 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: 6 to < 36 Months | Group 2: 3 to < 9 Years | Group 3: 18 to < 65 Years | Group 4: >= 65 Years | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 6 | 0 | 1 | 10 |
| Not Hispanic or Latino | 56 | 55 | 60 | 59 | 230 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group 1: 6 to < 36 Months | Group 2: 3 to < 9 Years | Group 3: 18 to < 65 Years | Group 4: >= 65 Years | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 29 | 30 | 16 | 5 | 80 |
| White | 29 | 25 | 43 | 53 | 150 |
| More than one race | 1 | 6 | 1 | 1 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Ran from Sep 2017 to primary completion in Nov 2017, 2 months.
Results were first posted in Dec 2018, 1 year after primary completion.
Of 37 industry-sponsored phase 4 interventional studies under Influenza, Human, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 6. This study's 2 months is below that.
Counting every sponsor, half of 138 studies reached it within 14 months; a quarter within 3 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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