Trial Outcomes & Findings for Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study (NCT NCT01246479)

NCT ID: NCT01246479

Last Updated: 2020-03-18

Results Overview

Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 23 participants
• Primary outcome timeframe: Month 12
• Results posted on: 2020-03-18

Participant Flow

Participant milestones

Measure	No Treatment subjects will be followed up on immunity (analysis of blood samples) and safety Blood draw: blood draw at Month 12, Month 24 and Month 36. IC51 has given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
Overall Study STARTED	23
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study

Baseline characteristics by cohort

Measure	No Treatment n=23 Participants subjects will be followed up on immunity (analysis of blood samples) and safety Blood draw: blood draw at Month 12, Month 24 and Month 36. IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
Age, Continuous	14.3 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 12

Population: intention to treat population; assessment of seroprotection \~1 year post primary vaccination series in parent study IC51-322

Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)

Outcome measures

Measure	No Treatment n=19 Participants subjects will be followed up on immunity (analysis of blood samples) and safety Blood draw: blood draw at Month 12, Month 24 and Month 36. IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)	89.5 percentage of participants Interval 68.6 to 97.1

SECONDARY outcome

Timeframe: Month 12, 24 and 36

Population: Intent to Treat Population

GMT for JEV neutralizing antibodies measured using the PRNT at Month 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)

Outcome measures

Measure	No Treatment n=23 Participants subjects will be followed up on immunity (analysis of blood samples) and safety Blood draw: blood draw at Month 12, Month 24 and Month 36. IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) Month 36 - Visit 4	60.8 Titer Interval 34.8 to 106.1
GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) Month 12 - Visit 2	47.8 Titer Interval 28.7 to 79.8
GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) Month 24 - Visit 3	75.4 Titer Interval 45.9 to 123.7

SECONDARY outcome

Timeframe: Month 24, 36

Population: Intent to Treat Population

Rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)

Outcome measures

Measure	No Treatment n=23 Participants subjects will be followed up on immunity (analysis of blood samples) and safety Blood draw: blood draw at Month 12, Month 24 and Month 36. IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322) Seroprotection Rate - Month 24 - Visit 3	91.3 percentage of participants
Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322) Seroprotection Rate - Month 36 - Visit 4	89.5 percentage of participants

SECONDARY outcome

Timeframe: Months 12, 24 and 36

Population: Safety Population

Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)

Outcome measures

Measure	No Treatment n=23 Participants subjects will be followed up on immunity (analysis of blood samples) and safety Blood draw: blood draw at Month 12, Month 24 and Month 36. IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) Month 12 - Visit 2	1 Participants
Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) Month 24 - Visit 3	2 Participants
Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) Month 36 - Visit 4	2 Participants

SECONDARY outcome

Timeframe: Months 12, 24 and 36

Population: Safety Population

Rate of subjects with AEs and medically attended AEs up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322).

Outcome measures

Measure	No Treatment n=23 Participants subjects will be followed up on immunity (analysis of blood samples) and safety Blood draw: blood draw at Month 12, Month 24 and Month 36. IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322). Medically attended - Month 12 - Visit 2	7 Participants
Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322). Medically attended - Month 36 - Visit 4	7 Participants
Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322). Any AE up to Month 12	8 Participants
Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322). Medically attended - Month 24 - Visit 3	7 Participants
Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322). Any AE up to Month 24	8 Participants
Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322). Any AE up to Month 36	8 Participants

Adverse Events

No Treatment

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	No Treatment n=23 participants at risk subjects will be followed up on immunity (analysis of blood samples) and safety Blood draw: blood draw at Month 12, Month 24 and Month 36. IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
Infections and infestations Staphylococcal infection	4.3% 1/23 • Number of events 1 • adverse event data were collected up to month 36 (i.e., approximately 3 years after primary immunization in the parent study IC51-322)
Infections and infestations Tonsillitis	4.3% 1/23 • Number of events 1 • adverse event data were collected up to month 36 (i.e., approximately 3 years after primary immunization in the parent study IC51-322)

Other adverse events

Measure	No Treatment n=23 participants at risk subjects will be followed up on immunity (analysis of blood samples) and safety Blood draw: blood draw at Month 12, Month 24 and Month 36. IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
Infections and infestations Otitis media acute	8.7% 2/23 • adverse event data were collected up to month 36 (i.e., approximately 3 years after primary immunization in the parent study IC51-322)
Infections and infestations Pharyngitis streptococcal	8.7% 2/23 • adverse event data were collected up to month 36 (i.e., approximately 3 years after primary immunization in the parent study IC51-322)
Gastrointestinal disorders Diarrhoea	8.7% 2/23 • adverse event data were collected up to month 36 (i.e., approximately 3 years after primary immunization in the parent study IC51-322)
Skin and subcutaneous tissue disorders Skin papilloma	8.7% 2/23 • adverse event data were collected up to month 36 (i.e., approximately 3 years after primary immunization in the parent study IC51-322)

Additional Information

Senior Scientist Clinical Research

Valneva Austria GmbH

Phone: +43120620

Email: info@valneva.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60