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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02759354
Other study ID # V419-012
Secondary ID 2016-000274-37PR
Status Completed
Phase Phase 3
First received
Last updated
Start date April 26, 2016
Est. completion date August 1, 2016

Study information

Verified date May 2020
Source MCM Vaccines B.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 754
Est. completion date August 1, 2016
Est. primary completion date July 29, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood Sample
Blood sample at approx. 4 years of age

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
MCM Vaccines B.V. Merck Sharp & Dohme Corp., Sanofi Pasteur, a Sanofi Company

References & Publications (1)

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: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Percentage of Participants With One or More Serious Adverse Events Related to Study Procedure 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. Up to 4 days following blood sample on Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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