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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

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ClinicalTrials.gov Identifier: NCT02759354
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : October 18, 2017
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
MCM Vaccines B.V.

Brief Summary:
To describe 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

Condition or disease Intervention/treatment Phase
Hepatitis B Pertussis Other: Blood Sample Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 756 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : April 26, 2016
Actual Primary Completion Date : August 1, 2016
Actual Study Completion Date : August 1, 2016


Arm Intervention/treatment
Experimental: Group V3
Subjects previously vaccinated with a 3+1 schedule with VAXELIS
Other: Blood Sample
Blood sample at approx. 4 years of age

Active Comparator: Group I3
Subjects previously vaccinated with a 3+1 schedule with Infanrix hexa
Other: Blood Sample
Blood sample at approx. 4 years of age

Experimental: Group V2
Subjects previously vaccinated with a 2+1 schedule with VAXELIS
Other: Blood Sample
Blood sample at approx. 4 years of age

Active Comparator: Group I2
Subjects previously vaccinated with a 2+1 schedule with Infanrix hexa
Other: Blood Sample
Blood sample at approx. 4 years of age




Primary Outcome Measures :
  1. Anti-hepatitis B surface antigen (HBs) concentration ≥ 10 mIU/mL [ Time Frame: Day 1 ]
  2. Percentage of participants with anti-pertussis toxin, anti-filamentous hemagglutinin, anti- pertactin, and anti-fimbriae concentrations ≥ the lower limit of quantification (LLOQ), ≥ 2x LLOQ, and ≥ 4x LLOQ [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Anti-HBs Geometric Mean Concentration (GMC) [ Time Frame: Day 1 ]
  2. Anti-Pertussis Geometric Mean Concentration (GMC) [ Time Frame: Day 1 ]

Other Outcome Measures:
  1. Serious Adverse Event related to study procedure [ Time Frame: Within 3-4 days following Blood Sample taken on Day 1 ]


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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 subject's parent(s) or legal representative.

Exclusion Criteria:

  1. Subject who has received any dose of HB containing vaccine at any time other than study vaccine in V419-007 or V419-008 study;
  2. Subject with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study;
  3. Subject who has received any dose of pertussis containing vaccine after completion of the V419-008 study;
  4. Subject 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. Subject 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. Subject 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759354


Locations
Finland
SPMSD Investigational Site 0007
Espoo, Finland
SPMSD Investigational Site 0005
Helsinki, Finland
SPMSD Investigational Site 0006
Helsinki, Finland
SPMSD Investigational Site 0004
Jarvenpaa, Finland
SPMSD Investigational Site 0010
Kokkola, Finland
SPMSD Investigational Site 0008
Oulu, Finland
SPMSD Investigational Site 0003
Pori, Finland
SPMSD Investigational Site 0009
Seinajoki, Finland
SPMSD Investigational Site 0001
Tampere, Finland
SPMSD Investigational Site 0002
Turku, Finland
Sponsors and Collaborators
MCM Vaccines B.V.
Merck Sharp & Dohme Corp.
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: MCM Vaccines B.V.
ClinicalTrials.gov Identifier: NCT02759354     History of Changes
Other Study ID Numbers: V419-012
2016-000274-37 ( EudraCT Number )
PRI03C ( Other Identifier: MCMVaccBV Protocol ID )
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by MCM Vaccines B.V.:
Immune response

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Whooping Cough
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs