Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012)

Phase 3

Completed

• Conditions: Hepatitis B; Pertussis
• Interventions: Other: Blood Sample

• Registration Number: NCT02759354
• Lead Sponsor: MCM Vaccines B.V.

Brief Summary

This is a multicenter extension study of two European randomized, double-blind studies (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis antibody responses in healthy 4- to 5 year old children previously vaccinated with Vaxelis® or INFANRIX® hexa

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-26
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-03
• Primary Completion: 2016-07-29
• Study Completion: 2016-08-01
• Results First Submitted: 2019-01-25
• Results First Submitted QC: 2019-03-18
• Results First Posted: 2019-06-27
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 754

Inclusion Criteria

Not provided

Exclusion Criteria

1. Participant who has received any dose of hepatitis B (HB)-containing vaccine at any time other than study vaccine in V419-007 or V419-008 study.

2. Participant with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study.

3. Participant who has received any dose of pertussis-containing vaccine after completion of the V419-008 study.

4. Participant with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of V419-008 study.

5. Participation at the time of study enrolment or in the 4 weeks preceding the study enrolment in another clinical study investigating a vaccine, drug medical device, or medical procedure*.

6. Participant who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion*.

7. Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy since completion of V419-007 or V419-008 studies.

8. Participant with suspected or known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopietic and lymphatic systems since completion of V419-007 or V419-008 studies.

   • Criteria 5 and 6 are temporary exclusion criteria. If a participant meets criteria 5 and/or 6 at the time of Visit 1, a further appointment is to be scheduled to reassess the participant's eligibility.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Infanrix hexa (3+1)	Blood Sample	Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007).
Group Vaxelis (3+1)	Blood Sample	Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007).
Group Infanrix hexa (2+1)	Blood Sample	Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008).
Group Vaxelis (2+1)	Blood Sample	Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Responding to Pertussis Toxin	Day 1 (approximately 4 years after completion of the 2+1 schedule)	Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. The unit of measure is ELISA units/mL. The lower limit of quantification (LLOQ)=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Percentage of Participants Responding to Pertussis Fimbriae	Day 1 (approximately 4 years after completion of the 2+1 schedule)	Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg)	Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule)	Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. Response was defined as a titer \>=10 milli International units (mIU)/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin	Day 1 (approximately 4 years after completion of the 2+1 schedule)	Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. LLOQ=3 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Percentage of Participants Responding to Pertussis Pertactin	Day 1 (approximately 4 years after completion of the 2+1 schedule)	Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae	Day 1 (approximately 4 years after completion of the 2+1 schedule)	Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.
Geometric Mean Concentration of Antibodies to HBsAg	Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)	Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. The unit of measure is milli International Units/mL (mIU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.
Geometric Mean Concentration of Antibodies to Pertussis Toxin	Day 1 (approximately 4 years after completion of the 2+1 schedule)	Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin	Day 1 (approximately 4 years after completion of the 2+1 schedule)	Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.
Geometric Mean Concentration of Antibodies to Pertussis Pertactin	Day 1 (approximately 4 years after completion of the 2+1 schedule)	Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.