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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 Vaxelis® or INFANRIX® Hexa (V419-012)

Primary Purpose

Hepatitis B, Pertussis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Blood Sample
Sponsored by
MCM Vaccines B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Immune response

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  1. 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.
  2. Informed consent signed by the participant's parent(s) or legal representative.

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Group Vaxelis (3+1)

    Group Infanrix hexa (3+1)

    Group Vaxelis (2+1)

    Group Infanrix hexa (2+1)

    Arm Description

    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).

    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).

    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).

    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).

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    April 29, 2016
    Last Updated
    May 27, 2020
    Sponsor
    MCM Vaccines B.V.
    Collaborators
    Merck Sharp & Dohme LLC, Sanofi Pasteur, a Sanofi Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02759354
    Brief Title
    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)
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 26, 2016 (Actual)
    Primary Completion Date
    July 29, 2016 (Actual)
    Study Completion Date
    August 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    MCM Vaccines B.V.
    Collaborators
    Merck Sharp & Dohme LLC, Sanofi Pasteur, a Sanofi Company

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B, Pertussis
    Keywords
    Immune response

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    754 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Vaxelis (3+1)
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Group Infanrix hexa (3+1)
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    Group Vaxelis (2+1)
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Group Infanrix hexa (2+1)
    Arm Type
    Active Comparator
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Blood Sample
    Other Intervention Name(s)
    Vaxelis®, INFANRIX® hexa
    Intervention Description
    Blood sample at approx. 4 years of age
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg)
    Description
    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.
    Time Frame
    Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule)
    Title
    Percentage of Participants Responding to Pertussis Toxin
    Description
    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.
    Time Frame
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Title
    Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
    Description
    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.
    Time Frame
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Title
    Percentage of Participants Responding to Pertussis Pertactin
    Description
    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.
    Time Frame
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Title
    Percentage of Participants Responding to Pertussis Fimbriae
    Description
    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.
    Time Frame
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Secondary Outcome Measure Information:
    Title
    Geometric Mean Concentration of Antibodies to HBsAg
    Description
    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.
    Time Frame
    Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)
    Title
    Geometric Mean Concentration of Antibodies to Pertussis Toxin
    Description
    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.
    Time Frame
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Title
    Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
    Description
    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.
    Time Frame
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Title
    Geometric Mean Concentration of Antibodies to Pertussis Pertactin
    Description
    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.
    Time Frame
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Title
    Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
    Description
    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.
    Time Frame
    Day 1 (approximately 4 years after completion of the 2+1 schedule)
    Other Pre-specified Outcome Measures:
    Title
    Percentage of Participants With One or More Serious Adverse Events Related to Study Procedure
    Description
    An SAE is any untoward medical occurrence or effect that at any dose results in death or is life threatening. Life-threatening in this context refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe.
    Time Frame
    Up to 4 days following blood sample on Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    31689166
    Citation
    Vesikari T, Xu J, Johnson DR, Hall J, Marcek T, Goveia MG, Acosta CJ, Lee AW. Hepatitis B and pertussis antibodies in 4- to 5-year-old children previously vaccinated with different hexavalent vaccines. Hum Vaccin Immunother. 2020 Apr 2;16(4):867-874. doi: 10.1080/21645515.2019.1673119. Epub 2019 Nov 5.
    Results Reference
    result

    Learn more about this trial

    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)

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