A Phase 3 interventional study of TBE vaccine 0.5 mL and TBE vaccine 0.25 mL in Tick-Borne Encephalitis, sponsored by Pfizer. Completed at 6 sites in Japan. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Pfizer · Phase 3, Interventional, and Prevention
The main purpose of this study is to provide safety and immunogenicity data in Japanese participants.
51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.
This study's enrollment of 165 is below the median of 192 across 32 interventional studies indexed under Encephalitis, Tick-Borne.
Browse Encephalitis, Tick-Borne studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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 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.
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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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 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.
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.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TBE vaccine 0.5 mL (intramuscular injection).
Biological: TBE vaccine 0.5 mL
TBE vaccine 0.25ｍL (intramuscular injection).
Biological: TBE vaccine 0.25 mL
TBE vaccine 0.5 mL (intramuscular injection).
TBE vaccine 0.25 mL (intramuscular injection).
Percentage of Seropositive Participants at 4 Weeks After Dose 3
Seropositivity rate based on the immune response was determined by neutralization test (NT). Participants who achieved tick-borne encephalitis virus (TBEV) NT titers \>=1: 10 were considered as seropositive. Exact 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
Time frame: 4 weeks after Dose 3
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1
LR:participant or legally acceptable representative/parent/legal guardian using an electronic diary (e-diary). LR included redness, swelling and pain at injection site. Redness and swelling were measured using measuring device units. 1 measuring device unit =0.5 centimeter(cm). Redness and swelling were graded as: for participants \>=12 years of age, mild(greater than\[\>\] 2.0 to 5.0 cm), moderate(\>5.0 to 10.0 cm) and severe (\>10.0 cm); for participants less than (\<)12 years of age, mild(\>0 to 2.0 cm), moderate(\>2.0 to7.0 cm) and severe(\>7.0 cm). Pain at the injection site was graded as: for participants \>2 years of age, mild(does not interfere with activity), moderate(interferes with activity) and severe(prevents daily activity); for participants less than or equal to (\<=)2 years of age, mild(hurts if gently touched) moderate(hurts if gently touched with crying) and severe(causes limitation of limb movement). Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: Within 7 days after Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Local reactions were collected by participant or legally acceptable representative/parent/legal guardian using an e-diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured using measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as: for participants \>=12 years of age, mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm); for participants \<12 years of age, mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at the injection site was graded as: for participants \>2 years of age, mild (does not interfere with activity), moderate (interferes with activity) and severe (prevents daily activity); for participants \<=2 years of age, mild (hurts if gently touched) moderate (hurts if gently touched with crying) and severe (causes limitation of limb movement). Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: Within 7 days after Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Local reactions were collected by participant or legally acceptable representative/parent/legal guardian using an e-diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured using measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as: for participants \>=12 years of age, mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm); for participants \<12 years of age, mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at the injection site was graded as: for participants \>2 years of age, mild (does not interfere with activity), moderate (interferes with activity) and severe (prevents daily activity); for participants \<=2 years of age, mild (hurts if gently touched) moderate (hurts if gently touched with crying) and severe (causes limitation of limb movement). Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: Within 7 days after Dose 3
Percentage of Participants With Systemic Events (SE) Within 7 Days After Dose 1
SE:participants or legally acceptable representative/parent/legal guardian using e-diary \& included fever:temperature \>=37.5 degree Celsius(C)\&categorized as 37.5to38.4, 38.5 to 38.9,39.0 to 40.0,\>40.0 degree C.Fatigue, headache, muscle pain, joint pain: mild(didn't interfere with activity), moderate(some interference with activity), severe(prevented daily activity). Vomiting: mild(1-2 times in 24 hours\[hrs\]), moderate(\>2 times in 24hrs), severe(required intravenous hydration). Diarrhea: mild(2-3 loose stools in 24hrs), moderate(4-5 loose stools in 24hrs), severe(6 or more loose stools in 24hrs). Decreased appetite:mild(decreased interest in eating),moderate(decreased oral intake), severe(refusal to feed).Drowsiness: mild(Increased sleeping bouts),moderate(slightly subdued interfering with daily activity),severe(disabling not interested in usual daily activity).Irritability:mild(easily consolable), moderate(required increased attention),severe(inconsolable, crying can't be comforted).
Time frame: Within 7 days after Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
SE:participants or a legally acceptable representative/parent/legal guardian using e-diary and included fever:temperature \>=37.5 degreeC \& categorized as 37.5 to 38.4,38.5 to 38.9,39.0 to 40.0,\>40.0 degreeC.Fatigue, headache, muscle pain, joint pain: mild(didn't interfere with activity),moderate(some interference with activity), severe(prevented daily activity). Vomiting: mild(1-2 times in 24 hours\[hrs\]), moderate(\>2 times in 24hrs),severe(required intravenous hydration).Diarrhea: mild(2-3 loose stools in 24hrs), moderate(4-5 loose stools in 24hrs), severe(6 or more loose stools in 24hrs). Decreased appetite: mild(decreased interest in eating), moderate(decreased oral intake), severe(refusal to feed). Drowsiness: mild(Increased sleeping bouts), moderate(slightly subdued interfering with daily activity), severe(disabling not interested in usual daily activity).Irritability: mild(easily consolable), moderate(required increased attention),severe(inconsolable, crying can't be comforted).
Time frame: Within 7 days after Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Systemic events collected by participant using e-diary and included fever defined as temperature \>=37.5 degree C and categorized as 37.5 to 38.4, 38.5 to 38.9, 39.0 to 40.0, \>40.0 degree C. Fatigue, headache, muscle pain, joint pain: mild(didn't interfere with activity), moderate(some interference with activity), severe(prevented daily activity). Vomiting: mild(1-2 times in 24 hours\[hrs\]), moderate(\>2 times in 24hrs), severe(required intravenous hydration). Diarrhea: mild(2-3 loose stools in 24hrs), moderate(4-5 loose stools in 24hrs), severe(6 or more loose stools in 24hrs). Decreased appetite: mild(decreased interest in eating), moderate(decreased oral intake), severe(refusal to feed). Drowsiness: mild(Increased sleeping bouts), moderate(slightly subdued interfering with daily activity), severe(disabling not interested in usual daily activity). Irritability: mild(easily consolable), moderate(required increased attention), severe(inconsolable, crying can't be comforted).
Time frame: Within 7 days after Dose 3
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 1
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: Within 1 month after Dose 1
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 2
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: Within 1 month after Dose 2
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 3
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: Within 1 month after Dose 3
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Any Dose
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: Within 1 month after any Dose
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
An SAE was defined as any untoward medical occurrence that, at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that is considered to be an important medical event. Percentage of participants with SAEs and the exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: From Day 1 up to end of study (up to approximately 13 months)
Percentage of Seropositive Participants at 4 Weeks After Dose 2
Seropositivity rate based on the immune response was determined by NT. Participants who achieved TBEV NT titers \>=1: 10 were considered as seropositive. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: 4 weeks after Dose 2
Geometric Mean Titers (GMTs) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 2 and Dose 3
GMTs and associated 2-sided 95% CIs were calculated as the mean of the assay results on the natural logarithmic scale based on Student's t distribution and then exponentiating the results. The lower limit of quantitation (LLOQ) value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ.
Time frame: 4 weeks after Dose 2 and Dose 3
Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 2 as Compared to Baseline
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). The LLOQ value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ.
Time frame: From Baseline to 4 weeks after Dose 2
Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 3 as Compared to Baseline
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). The LLOQ value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ.
Time frame: From Baseline to 4 weeks after Dose 3
Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 3 as Compared to 4 Weeks After Dose 2
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). The LLOQ value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ.
Time frame: From 4 weeks after Dose 2 to 4 weeks after Dose 3
Percentage of Participants With Neutralizing Antibody Titers >= Lower Limit of Quantification (LLOQ)
The LLOQ value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ. Percentage of participants with NT\>=LLOQ and exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time frame: Before Dose 1, 4 weeks after Dose 2, Before Dose 3 and 4 weeks after Dose 3
This study was conducted as part of the Phase 3 clinical development plan to support the use of tick-borne encephalitis (TBE) vaccine 0.5 milliliter (mL) in healthy Japanese adults (greater than or equal to \[\>=\] 16 years old) and 0.25 mL in pediatric participants (\>=1 and less than \[\<\] 16 years old) at investigator sites in Japan.
| Milestone | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Started | 100 | 65 |
| Completed | 99 | 65 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
Seropositivity rate based on the immune response was determined by neutralization test (NT). Participants who achieved tick-borne encephalitis virus (TBEV) NT titers \>=1: 10 were considered as seropositive. Exact 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Percentage of Seropositive Participants at 4 Weeks After Dose 3 | 98.0 (92.9 to 99.8) | 100 (94.5 to 100) |
LR:participant or legally acceptable representative/parent/legal guardian using an electronic diary (e-diary). LR included redness, swelling and pain at injection site. Redness and swelling were measured using measuring device units. 1 measuring device unit =0.5 centimeter(cm). Redness and swelling were graded as: for participants \>=12 years of age, mild(greater than\[\>\] 2.0 to 5.0 cm), moderate(\>5.0 to 10.0 cm) and severe (\>10.0 cm); for participants less than (\<)12 years of age, mild(\>0 to 2.0 cm), moderate(\>2.0 to7.0 cm) and severe(\>7.0 cm). Pain at the injection site was graded as: for participants \>2 years of age, mild(does not interfere with activity), moderate(interferes with activity) and severe(prevents daily activity); for participants less than or equal to (\<=)2 years of age, mild(hurts if gently touched) moderate(hurts if gently touched with crying) and severe(causes limitation of limb movement). Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Redness: Mild | 2.0 (0.2 to 7.0) | 3.1 (0.4 to 10.7) |
| Redness: Moderate | 0 (0.0 to 3.6) | 1.5 (0.0 to 8.3) |
| Redness: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 5.5) |
| Swelling: Mild | 3.0 (0.6 to 8.5) | 3.1 (0.4 to 10.7) |
| Swelling: Moderate | 0 (0.0 to 3.6) | 0 (0.0 to 5.5) |
| Swelling: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 5.5) |
| Pain at the injection site: Mild | 52.0 (41.8 to 62.1) | 36.9 (25.3 to 49.8) |
| Pain at the injection site: Moderate | 7.0 (2.9 to 13.9) | 6.2 (1.7 to 15.0) |
| Pain at the injection site: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 5.5) |
Local reactions were collected by participant or legally acceptable representative/parent/legal guardian using an e-diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured using measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as: for participants \>=12 years of age, mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm); for participants \<12 years of age, mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at the injection site was graded as: for participants \>2 years of age, mild (does not interfere with activity), moderate (interferes with activity) and severe (prevents daily activity); for participants \<=2 years of age, mild (hurts if gently touched) moderate (hurts if gently touched with crying) and severe (causes limitation of limb movement). Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Redness: Mild | 0.0 (0.0 to 3.6) | 3.1 (0.4 to 10.7) |
| Redness: Moderate | 0 (0.0 to 3.6) | 0 (0.0 to 5.5) |
| Redness: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 5.5) |
| Swelling: Mild | 0 (0.0 to 3.6) | 1.5 (0.0 to 8.3) |
| Swelling: Moderate | 0 (0.0 to 3.6) | 0 (0.0 to 5.5) |
| Swelling: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 5.5) |
| Pain at the injection site: Mild | 40.0 (30.3 to 50.3) | 24.6 (14.8 to 36.9) |
| Pain at the injection site: Moderate | 4.0 (1.1 to 9.9) | 1.5 (0.0 to 8.3) |
| Pain at the injection site: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 5.5) |
Local reactions were collected by participant or legally acceptable representative/parent/legal guardian using an e-diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured using measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as: for participants \>=12 years of age, mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm); for participants \<12 years of age, mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at the injection site was graded as: for participants \>2 years of age, mild (does not interfere with activity), moderate (interferes with activity) and severe (prevents daily activity); for participants \<=2 years of age, mild (hurts if gently touched) moderate (hurts if gently touched with crying) and severe (causes limitation of limb movement). Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Redness: Mild | 2.0 (0.2 to 7.1) | 7.7 (2.5 to 17.0) |
| Redness: Moderate | 0 (0.0 to 3.7) | 0 (0.0 to 5.5) |
| Redness: Severe | 0 (0.0 to 3.7) | 0 (0.0 to 5.5) |
| Swelling: Mild | 1.0 (0.0 to 5.5) | 6.2 (1.7 to 15.0) |
| Swelling: Moderate | 1.0 (0.0 to 5.5) | 3.1 (0.4 to 10.7) |
| Swelling: Severe | 0 (0.0 to 3.7) | 0 (0.0 to 5.5) |
| Pain at the injection site: Mild | 33.3 (24.2 to 43.5) | 30.8 (19.9 to 43.4) |
| Pain at the injection site: Moderate | 3.0 (0.6 to 8.6) | 4.6 (1.0 to 12.9) |
| Pain at the injection site: Severe | 0 (0.0 to 3.7) | 0 (0.0 to 5.5) |
SE:participants or legally acceptable representative/parent/legal guardian using e-diary \& included fever:temperature \>=37.5 degree Celsius(C)\&categorized as 37.5to38.4, 38.5 to 38.9,39.0 to 40.0,\>40.0 degree C.Fatigue, headache, muscle pain, joint pain: mild(didn't interfere with activity), moderate(some interference with activity), severe(prevented daily activity). Vomiting: mild(1-2 times in 24 hours\[hrs\]), moderate(\>2 times in 24hrs), severe(required intravenous hydration). Diarrhea: mild(2-3 loose stools in 24hrs), moderate(4-5 loose stools in 24hrs), severe(6 or more loose stools in 24hrs). Decreased appetite:mild(decreased interest in eating),moderate(decreased oral intake), severe(refusal to feed).Drowsiness: mild(Increased sleeping bouts),moderate(slightly subdued interfering with daily activity),severe(disabling not interested in usual daily activity).Irritability:mild(easily consolable), moderate(required increased attention),severe(inconsolable, crying can't be comforted).
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (3 to 15 Years Old) | Pediatric (1 to 2 Years Old) |
|---|---|---|---|
| Fever: >=37.5 degree C | 2.0 (0.2 to 7.0) | 5.3 (1.1 to 14.6) | 25.0 (3.2 to 65.1) |
| Fever: 37.5 to 38.4 degree C | 2.0 (0.2 to 7.0) | 3.5 (0.4 to 12.1) | 25.0 (3.2 to 65.1) |
| Fever: 38.5 to 38.9 degree C | 0 (0.0 to 3.6) | 1.8 (0.0 to 9.4) | 0 (0.0 to 36.9) |
| Fever: 39.0 to 40.0 degree C | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | 0 (0.0 to 36.9) |
| Fever: >40.0 degree C | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | 0 (0.0 to 36.9) |
| Fatigue: Mild | 11.0 (5.6 to 18.8) | 8.8 (2.9 to 19.3) | — |
| Fatigue: Moderate | 5.0 (1.6 to 11.3) | 1.8 (0.0 to 9.4) | — |
| Fatigue: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Headache: Mild | 7.0 (2.9 to 13.9) | 7.0 (1.9 to 17.0) | — |
| Headache: Moderate | 6.0 (2.2 to 12.6) | 1.8 (0.0 to 9.4) | — |
| Headache: Severe | 0 (0.0 to 3.6) | 1.8 (0.0 to 9.4) | — |
| Vomiting: Mild | 1.0 (0.0 to 5.4) | 0 (0.0 to 6.3) | — |
| Vomiting: Moderate | 1.0 (0.0 to 5.4) | 0 (0.0 to 6.3) | — |
| Vomiting: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Diarrhea: Mild | 7.0 (2.9 to 13.9) | 8.8 (1.9 to 19.3) | — |
| Diarrhea: Moderate | 2.0 (0.2 to 7.0) | 0 (0.0 to 6.3) | — |
| Diarrhea: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Muscle pain: Mild | 16.0 (9.4 to 24.7) | 5.3 (1.1 to 14.6) | — |
| Muscle pain: Moderate | 3.0 (0.6 to 8.5) | 0 (0.0 to 6.3) | — |
| Muscle pain: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Joint pain: Mild | 4.0 (1.1 to 9.9) | 0 (0.0 to 6.3) | — |
| Joint pain: Moderate | 3.0 (0.6 to 8.5) | 0 (0.0 to 6.3) | — |
| Joint pain: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Decreased appetite: Mild | — | — | 0 (0.0 to 36.9) |
| Decreased appetite: Moderate | — | — | 12.5 (0.3 to 52.7) |
| Decreased appetite: Severe | — | — | 0 (0.0 to 36.9) |
| Drowsiness: Mild | — | — | 25.0 (3.2 to 65.1) |
| Drowsiness: Moderate | — | — | 0 (0.0 to 36.9) |
| Drowsiness: Severe | — | — | 0 (0.0 to 36.9) |
| Irritability: Mild | — | — | 12.5 (0.3 to 52.7) |
| Irritability: Moderate | — | — | 12.5 (0.3 to 52.7) |
| Irritability: Severe | — | — | 0 (0.0 to 36.9) |
SE:participants or a legally acceptable representative/parent/legal guardian using e-diary and included fever:temperature \>=37.5 degreeC \& categorized as 37.5 to 38.4,38.5 to 38.9,39.0 to 40.0,\>40.0 degreeC.Fatigue, headache, muscle pain, joint pain: mild(didn't interfere with activity),moderate(some interference with activity), severe(prevented daily activity). Vomiting: mild(1-2 times in 24 hours\[hrs\]), moderate(\>2 times in 24hrs),severe(required intravenous hydration).Diarrhea: mild(2-3 loose stools in 24hrs), moderate(4-5 loose stools in 24hrs), severe(6 or more loose stools in 24hrs). Decreased appetite: mild(decreased interest in eating), moderate(decreased oral intake), severe(refusal to feed). Drowsiness: mild(Increased sleeping bouts), moderate(slightly subdued interfering with daily activity), severe(disabling not interested in usual daily activity).Irritability: mild(easily consolable), moderate(required increased attention),severe(inconsolable, crying can't be comforted).
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (3 to 15 Years Old) | Pediatric (1 to 2 Years Old) |
|---|---|---|---|
| Fever: >=37.5 degree C | 1.0 (0.0 to 5.4) | 7.0 (1.9 to 17.0) | 0 (0.0 to 36.9) |
| Fever: 37.5 to 38.4 degree C | 1.0 (0.0 to 5.4) | 3.5 (0.4 to 12.1) | 0 (0.0 to 36.9) |
| Fever: 38.5 to 38.9 degree C | 0 (0.0 to 3.6) | 3.5 (0.4 to 12.1) | 0 (0.0 to 36.9) |
| Fever: 39.0 to 40.0 degree C | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | 0 (0.0 to 36.9) |
| Fever: >40.0 degree C | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | 0 (0.0 to 36.9) |
| Fatigue: Mild | 7.0 (2.9 to 13.9) | 1.8 (0.0 to 9.4) | — |
| Fatigue: Moderate | 1.0 (0.0 to 5.4) | 0 (0.0 to 6.3) | — |
| Fatigue: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Headache: Mild | 10.0 (4.9 to 17.6) | 0 (0.0 to 6.3) | — |
| Headache: Moderate | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Headache: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Vomiting: Mild | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Vomiting: Moderate | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Vomiting: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Diarrhea: Mild | 4.0 (1.1 to 9.9) | 7.0 (1.9 to 17.0) | — |
| Diarrhea: Moderate | 1.0 (0.0 to 5.4) | 0 (0.0 to 6.3) | — |
| Diarrhea: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Muscle pain: Mild | 2.0 (0.2 to 7.0) | 1.8 (0.0 to 9.4) | — |
| Muscle pain: Moderate | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Muscle pain: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Joint pain: Mild | 1.0 (0.0 to 5.4) | 0 (0.0 to 6.3) | — |
| Joint pain: Moderate | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Joint pain: Severe | 0 (0.0 to 3.6) | 0 (0.0 to 6.3) | — |
| Decreased appetite: Mild | — | — | 0 (0.0 to 36.9) |
| Decreased appetite: Moderate | — | — | 0 (0.0 to 36.9) |
| Decreased appetite: Severe | — | — | 0 (0.0 to 36.9) |
| Drowsiness: Mild | — | — | 12.5 (0.3 to 52.7) |
| Drowsiness: Moderate | — | — | 0 (0.0 to 36.9) |
| Drowsiness: Severe | — | — | 0 (0.0 to 36.9) |
| Irritability: Mild | — | — | 0 (0.0 to 36.9) |
| Irritability: Moderate | — | — | 0 (0.0 to 36.9) |
| Irritability: Severe | — | — | 0 (0.0 to 36.9) |
Systemic events collected by participant using e-diary and included fever defined as temperature \>=37.5 degree C and categorized as 37.5 to 38.4, 38.5 to 38.9, 39.0 to 40.0, \>40.0 degree C. Fatigue, headache, muscle pain, joint pain: mild(didn't interfere with activity), moderate(some interference with activity), severe(prevented daily activity). Vomiting: mild(1-2 times in 24 hours\[hrs\]), moderate(\>2 times in 24hrs), severe(required intravenous hydration). Diarrhea: mild(2-3 loose stools in 24hrs), moderate(4-5 loose stools in 24hrs), severe(6 or more loose stools in 24hrs). Decreased appetite: mild(decreased interest in eating), moderate(decreased oral intake), severe(refusal to feed). Drowsiness: mild(Increased sleeping bouts), moderate(slightly subdued interfering with daily activity), severe(disabling not interested in usual daily activity). Irritability: mild(easily consolable), moderate(required increased attention), severe(inconsolable, crying can't be comforted).
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (3 to 15 Years Old) | Pediatric (1 to 2 Years Old) |
|---|---|---|---|
| Fever: >=37.5 degree C | 1.0 (0.0 to 5.5) | 10.5 (4.0 to 21.5) | 12.5 (0.3 to 52.7) |
| Fever: 37.5 to 38.4 degree C | 0 (0.0 to 3.7) | 8.8 (2.9 to 19.3) | 12.5 (0.3 to 52.7) |
| Fever: 38.5 to 38.9 degree C | 1.0 (0.0 to 5.5) | 0 (0.0 to 6.3) | 0 (0.0 to 36.9) |
| Fever: 39.0 to 40.0 degree C | 0 (0.0 to 3.7) | 1.8 (0.0 to 9.4) | 0 (0.0 to 36.9) |
| Fever: >40.0 degree C | 0 (0.0 to 3.7) | 0 (0.0 to 6.3) | 0 (0.0 to 36.9) |
| Fatigue: Mild | 9.1 (4.2 to 16.6) | 1.8 (0.0 to 9.4) | — |
| Fatigue: Moderate | 2.0 (0.2 to 7.1) | 5.3 (1.1 to 14.6) | — |
| Fatigue: Severe | 0 (0.0 to 3.7) | 0 (0.0 to 6.3) | — |
| Headache: Mild | 9.1 (4.2 to 16.6) | 5.3 (1.1 to 14.6) | — |
| Headache: Moderate | 1.0 (0.0 to 5.5) | 3.5 (0.4 to 12.1) | — |
| Headache: Severe | 1.0 (0.0 to 5.5) | 0 (0.0 to 6.3) | — |
| Vomiting: Mild | 2.0 (0.2 to 7.1) | 1.8 (0.0 to 9.4) | — |
| Vomiting: Moderate | 0 (0.0 to 3.7) | 1.8 (0.0 to 9.4) | — |
| Vomiting: Severe | 0 (0.0 to 3.7) | 0 (0.0 to 6.3) | — |
| Diarrhea: Mild | 5.1 (1.7 to 11.4) | 5.3 (1.1 to 14.6) | — |
| Diarrhea: Moderate | 0 (0.0 to 3.7) | 3.5 (0.4 to 12.1) | — |
| Diarrhea: Severe | 1.0 (0.0 to 5.5) | 0 (0.0 to 6.3) | — |
| Muscle pain: Mild | 3.0 (0.6 to 8.6) | 1.8 (0.0 to 9.4) | — |
| Muscle pain: Moderate | 1.0 (0.0 to 5.5) | 0 (0.0 to 6.3) | — |
| Muscle pain: Severe | 0 (0.0 to 3.7) | 0 (0.0 to 6.3) | — |
| Joint pain: Mild | 0 (0.0 to 3.7) | 5.3 (1.1 to 14.6) | — |
| Joint pain: Moderate | 1.0 (0.0 to 5.5) | 0 (0.0 to 6.3) | — |
| Joint pain: Severe | 1.0 (0.0 to 5.5) | 0 (0.0 to 6.3) | — |
| Decreased appetite: Mild | — | — | 12.5 (0.3 to 52.7) |
| Decreased appetite: Moderate | — | — | 0 (0.0 to 36.9) |
| Decreased appetite: Severe | — | — | 0 (0.0 to 36.9) |
| Drowsiness: Mild | — | — | 25.0 (3.2 to 65.1) |
| Drowsiness: Moderate | — | — | 0 (0.0 to 36.9) |
| Drowsiness: Severe | — | — | 0 (0.0 to 36.9) |
| Irritability: Mild | — | — | 0 (0.0 to 36.9) |
| Irritability: Moderate | — | — | 0 (0.0 to 36.9) |
| Irritability: Severe | — | — | 0 (0.0 to 36.9) |
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 1 | 6.0 (2.2 to 12.6) | 21.5 (12.3 to 33.5) |
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 2 | 2.0 (0.2 to 7.0) | 10.8 (4.4 to 20.9) |
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 3 | 6.1 (2.3 to 12.7) | 29.2 (18.6 to 41.8) |
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Any Dose | 14.0 (7.9 to 22.4) | 41.5 (29.4 to 54.4) |
An SAE was defined as any untoward medical occurrence that, at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that is considered to be an important medical event. Percentage of participants with SAEs and the exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study | 2.0 (0.2 to 7.0) | 1.5 (0.0 to 8.3) |
Seropositivity rate based on the immune response was determined by NT. Participants who achieved TBEV NT titers \>=1: 10 were considered as seropositive. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of participants | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Percentage of Seropositive Participants at 4 Weeks After Dose 2 | 93 (86.1 to 97.1) | 92.3 (83.0 to 97.5) |
GMTs and associated 2-sided 95% CIs were calculated as the mean of the assay results on the natural logarithmic scale based on Student's t distribution and then exponentiating the results. The lower limit of quantitation (LLOQ) value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ.
| Titer | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| 4 Weeks after Dose 2 | 28.2 (23.5 to 33.8) | 29.4 (23.3 to 37.0) |
| 4 Weeks after Dose 3 | 80.1 (65.1 to 98.5) | 233.1 (187.9 to 289.1) |
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). The LLOQ value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ.
| Fold rise | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 2 as Compared to Baseline | 11.2 (9.3 to 13.4) | 11.8 (9.3 to 14.8) |
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). The LLOQ value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ.
| Fold rise | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 3 as Compared to Baseline | 32.0 (26.0 to 39.4) | 93.2 (75.2 to 115.6) |
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). The LLOQ value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ.
| Fold rise | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 3 as Compared to 4 Weeks After Dose 2 | 2.8 (2.3 to 3.5) | 7.9 (6.2 to 10.2) |
The LLOQ value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ. Percentage of participants with NT\>=LLOQ and exact 2-sided 95% CI based on the Clopper and Pearson method was presented.
| Percentage of Participants | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Before Dose 1 | 0 (0.0 to 3.7) | 0 (0.0 to 5.5) |
| 4 Weeks after Dose 2 | 96.0 (90.0 to 98.9) | 98.5 (91.7 to 100.0) |
| Before Dose 3 | 63.6 (53.4 to 73.1) | 86.2 (75.3 to 93.5) |
| 4 Weeks after Dose 3 | 99.0 (94.5 to 100.0) | 100.0 (94.5 to 100.0) |
Collected over All-Cause mortality and SAEs: from Day 1 up to end of study (up to approximately 13 months); Other AEs (non-systematic assessment): up to 1 month after each Dose; Local reactions and systemic events (systematic assessment, included in other AEs): within 7 days after each Dose. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adults (>=16 Years Old) | 0/100 (0%) | 2/100 (2%) | 76/100 (76%) |
| Pediatric (1 to <16 Years Old) | 0/65 (0%) | 1/65 (1.5%) | 59/65 (90.8%) |
| Event | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 0/100 | 1/65 |
| Abdominal painGastrointestinal disorders | 1/100 | 0/65 |
| Colitis ischaemicGastrointestinal disorders | 1/100 | 0/65 |
| Event | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) |
|---|---|---|
| Injection site pain (PAIN)General disorders | 68/100 | 43/65 |
| Fatigue (FATIGUE)General disorders | 27/100 | 9/65 |
| Headache (HEADACHE)Nervous system disorders | 23/100 | 9/65 |
| Myalgia (MUSCLE PAIN)Musculoskeletal and connective tissue disorders | 22/100 | 4/65 |
| Pyrexia (FEVER)General disorders | 3/100 | 13/65 |
| Diarrhoea (DIARRHEA)Gastrointestinal disorders | 15/100 | 12/65 |
| NasopharyngitisInfections and infestations | 3/100 | 11/65 |
| Injection site swelling (SWELLING)General disorders | 4/100 | 9/65 |
| GastroenteritisInfections and infestations | 1/100 | 8/65 |
| Injection site erythema (REDNESS)General disorders | 3/100 | 7/65 |
Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product.
| Age, Continuous(Years) | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) | Total |
|---|---|---|---|
| Mean | 44.3 ± 16.02 | 6.9 ± 3.89 | 29.5 ± 22.27 |
| Sex: Female, Male(Participants) | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) | Total |
|---|---|---|---|
| Female | 55 | 19 | 74 |
| Male | 45 | 46 | 91 |
| Ethnicity (NIH/OMB)(Participants) | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 100 | 65 | 165 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Adults (>=16 Years Old) | Pediatric (1 to <16 Years Old) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 100 | 65 | 165 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
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