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)

Study Overview
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Brief Summary
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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

Official Title
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Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year-Old Children Previously Vaccinated With a 2-Dose or 3-Dose Infants Series and Toddler Dose With Vaxelis® or INFANRIX® Hexa

Conditions
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Hepatitis B, Pertussis

Intervention / Treatment
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* Other: Blood Sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Healthy child of either gender, who has received a complete 3-dose primary series or a complete 2 dose primary series followed by a toddler dose with VAXELIS or INFANRIX hexa as part of the V419-007 or V419-008 study respectively. Informed consent signed by the participant's parent(s) or legal representative. Exclusion Criteria: 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. Participant with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study. Participant who has received any dose of pertussis-containing vaccine after completion of the V419-008 study. Participant with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of V419-008 study. 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*. Participant who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion*. 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. 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Vaxelis (3+1)<br>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). | Other: Blood Sample<br>* Blood sample at approx. 4 years of age<br>* Other names: INFANRIX® hexa;|
| Active Comparator: Group Infanrix hexa (3+1)<br>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). | Other: Blood Sample<br>* Blood sample at approx. 4 years of age<br>* Other names: INFANRIX® hexa;|
| Experimental: Group Vaxelis (2+1)<br>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). | Other: Blood Sample<br>* Blood sample at approx. 4 years of age<br>* Other names: INFANRIX® hexa;|
| Active Comparator: Group Infanrix hexa (2+1)<br>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). | Other: Blood Sample<br>* Blood sample at approx. 4 years of age<br>* Other names: INFANRIX® hexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg) | 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. | Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule) | 
| Percentage of Participants Responding to Pertussis Toxin | 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. | Day 1 (approximately 4 years after completion of the 2+1 schedule) | 
| Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 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. | Day 1 (approximately 4 years after completion of the 2+1 schedule) | 
| Percentage of Participants Responding to Pertussis Pertactin | 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. | Day 1 (approximately 4 years after completion of the 2+1 schedule) | 
| Percentage of Participants Responding to Pertussis Fimbriae | 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. | Day 1 (approximately 4 years after completion of the 2+1 schedule) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Concentration of Antibodies to HBsAg | 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. | Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule) | 
| Geometric Mean Concentration of Antibodies to Pertussis Toxin | 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. | Day 1 (approximately 4 years after completion of the 2+1 schedule) | 
| Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 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. | Day 1 (approximately 4 years after completion of the 2+1 schedule) | 
| Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 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. | Day 1 (approximately 4 years after completion of the 2+1 schedule) | 
| Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 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. | Day 1 (approximately 4 years after completion of the 2+1 schedule) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune response