Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Tick-Borne Encephalitis (TBE) Vaccine in Healthy Japanese Participants 1 Year of Age and Older

Tick-Borne Encephalitis Clinical Trial

Official title:

A PHASE 3, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A TICK-BORNE ENCEPHALITIS VACCINE IN HEALTHY JAPANESE PARTICIPANTS 1 YEAR OF AGE AND OLDER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648241
• Other study ID #: B9371039
• Status: Completed
• Phase: Phase 3
• Start date: January 18, 2021
• Est. completion date: February 21, 2022

Study information

• Verified date: February 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to provide safety and immunogenicity data in Japanese participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: February 21, 2022
• Est. primary completion date: February 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Japanese male or female participants =1 years old at Visit 1.

• Participants and/or a legally acceptable representative/parent/legal guardian are willing and able to comply with all scheduled visits, vaccination plan, and other study procedures including completion of the e-diary for 7 days for participants after each of 3 vaccinations.

• Participants and/or a legally acceptable representative/parent/legal guardian must be able to be contacted by telephone during study participation.

• Participants and/or a legally acceptable representative/parent/legal guardian are capable of giving signed informed consent.

Exclusion Criteria:

• Major known congenital malformation or serious chronic disorder.

• Known history of TBEV infection.

• Known history of other flavivirus infection (eg, dengue fever, yellow fever, JEV, West Nile virus).

• Known history of infection with HIV, HCV, or HBV.

• Immunocompromised participants with known or suspected immunodeficiency.

• History of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.

• Previous vaccination with any licensed or investigational TBE vaccine, or planned receipt of other flavivirus vaccines apart from JEV vaccine (eg, yellow fever, dengue fever) during the study. Administration of JEV vaccine is prohibited during participation.

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne
• Tick-Borne Encephalitis

Intervention

Biological:
• TBE vaccine 0.5 mL
TBE vaccine 0.5 mL (intramuscular injection).
• TBE vaccine 0.25 mL
TBE vaccine 0.25 mL (intramuscular injection).

Locations

Country	Name	City	State
Japan	Azuma kodomo katei clinic	Ebetsu Shi	Hokkaido
Japan	Medical Co. LTA PS Clinic	Fukuoka,	Fukuoka
Japan	Childrens clinic of Kose	Kofu-city	Yamanashi
Japan	Ohigesenseino Kodomo Clinic	Sapporo	Hokkaido
Japan	SUZURAN Children's Clinic	Sapporo	Hokkaido
Japan	Watanabe Pediatric Allergy Clinic	Sapporo	Hokkaido

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks after Dose 3
Primary	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.	Within 7 days after Dose 1
Primary	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.	Within 7 days after Dose 2
Primary	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.	Within 7 days after Dose 3
Primary	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).	Within 7 days after Dose 1
Primary	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).	Within 7 days after Dose 2
Primary	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).	Within 7 days after Dose 3
Primary	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.	Within 1 month after Dose 1
Primary	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.	Within 1 month after Dose 2
Primary	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.	Within 1 month after Dose 3
Primary	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.	Within 1 month after any Dose
Primary	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.	From Day 1 up to end of study (up to approximately 13 months)
Secondary	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.	4 weeks after Dose 2
Secondary	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.	4 weeks after Dose 2 and Dose 3
Secondary	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.	From Baseline to 4 weeks after Dose 2
Secondary	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.	From Baseline to 4 weeks after Dose 3
Secondary	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.	From 4 weeks after Dose 2 to 4 weeks after Dose 3
Secondary	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.	Before Dose 1, 4 weeks after Dose 2, Before Dose 3 and 4 weeks after Dose 3

External Links

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