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)
NCT ID: NCT02759354
Last Updated: 2020-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
754 participants
INTERVENTIONAL
2016-04-26
2016-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group Vaxelis (3+1)
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).
Blood Sample
Blood sample at approx. 4 years of age
Group Infanrix hexa (3+1)
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).
Blood Sample
Blood sample at approx. 4 years of age
Group Vaxelis (2+1)
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).
Blood Sample
Blood sample at approx. 4 years of age
Group Infanrix hexa (2+1)
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).
Blood Sample
Blood sample at approx. 4 years of age
Interventions
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Blood Sample
Blood sample at approx. 4 years of age
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Informed consent signed by the participant's parent(s) or legal representative.
Exclusion Criteria
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.
3 Years
5 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Sanofi Pasteur, a Sanofi Company
INDUSTRY
MCM Vaccines B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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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.
Other Identifiers
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2016-000274-37
Identifier Type: OTHER
Identifier Source: secondary_id
PRI03C
Identifier Type: OTHER
Identifier Source: secondary_id
V419-012
Identifier Type: OTHER
Identifier Source: secondary_id
V419-012
Identifier Type: -
Identifier Source: org_study_id
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