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)

Hepatitis B Clinical Trial

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Pertussis
• Whooping Cough

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)