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

NCT04648241 | Completed Phase 3 Results

• 1 other identifier: B9371039
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Tick-Borne Encephalitis

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Percentage of Seropositive Participants at 4 Weeks After Dose 2

  4 weeks after Dose 2

• Geometric Mean Titers (GMTs) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 2 and Dose 3

  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

  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

  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

  From 4 weeks after Dose 2 to 4 weeks after Dose 3

Study Arms (2)

≥16 Years Old

EXPERIMENTAL

TBE vaccine 0.5 mL (intramuscular injection).

Biological: TBE vaccine 0.5 mL

1 to <16 Years Old

EXPERIMENTAL

TBE vaccine 0.25ｍL (intramuscular injection).

Biological: TBE vaccine 0.25 mL

Interventions

TBE vaccine 0.5 mL BIOLOGICAL

TBE vaccine 0.5 mL (intramuscular injection).

≥16 Years Old

TBE vaccine 0.25 mL BIOLOGICAL

TBE vaccine 0.25 mL (intramuscular injection).

1 to <16 Years Old

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (6)

Medical Co. LTA PS Clinic

Fukuoka, Fukuoka, 812-0025, Japan

Location

Azuma kodomo katei clinic

Ebetsu Shi, Hokkaido, 069-0816, Japan

Location

Watanabe Pediatric Allergy Clinic

Sapporo, Hokkaido, 006-0831, Japan

Location

Ohigesenseino Kodomo Clinic

Sapporo, Hokkaido, 062-0907, Japan

Location

SUZURAN Children's Clinic

Sapporo, Hokkaido, 063-0841, Japan

Location

Childrens clinic of Kose

Kofu, Yamanashi, 400-0853, Japan

Location

Related Publications (1)

• Yonekawa M, Watanabe T, Kogawara O, Yoshii C, Yamaji M, Aizawa M, Erber W, Ito S, Jug B, Koelch D, de Solom R, Lockhart SP. Phase 3 immunogenicity and safety study of a tick-borne encephalitis vaccine in healthy Japanese participants 1 year of age and older. Vaccine. 2024 May 10;42(13):3180-3189. doi: 10.1016/j.vaccine.2024.03.071. Epub 2024 Apr 12.

  PMID: 38614954 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: December 1, 2020
• Study Start: January 18, 2021
• Primary Completion: February 21, 2022
• Study Completion: February 21, 2022
• Last Updated: November 22, 2023
• Results First Posted: November 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

JP (6)