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)

NCT02759354 | Completed Phase 3 Results

• 3 other identifiers: V419-0122016-000274-37PRI03C
• Study Type: interventional
• Target: 754
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hepatitis B; Pertussis

Keywords

Immune response

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (5)

• Geometric Mean Concentration of Antibodies to HBsAg

  Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)

• Geometric Mean Concentration of Antibodies to Pertussis Toxin

  Day 1 (approximately 4 years after completion of the 2+1 schedule)

• Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin

  Day 1 (approximately 4 years after completion of the 2+1 schedule)

• Geometric Mean Concentration of Antibodies to Pertussis Pertactin

  Day 1 (approximately 4 years after completion of the 2+1 schedule)

• Geometric Mean Concentration of Antibodies to Pertussis Fimbriae

  Day 1 (approximately 4 years after completion of the 2+1 schedule)

Other Outcomes (1)

• Percentage of Participants With One or More Serious Adverse Events Related to Study Procedure

  Up to 4 days following blood sample on Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)

Study Arms (4)

Group Vaxelis (3+1)

EXPERIMENTAL

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).

Other: Blood Sample

Group Infanrix hexa (3+1)

ACTIVE COMPARATOR

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).

Other: Blood Sample

Group Vaxelis (2+1)

EXPERIMENTAL

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).

Other: Blood Sample

Group Infanrix hexa (2+1)

ACTIVE COMPARATOR

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).

Other: Blood Sample

Interventions

Blood Sample OTHER

Blood sample at approx. 4 years of age

Also known as: Vaxelis®, INFANRIX® hexa

Group Infanrix hexa (2+1); Group Infanrix hexa (3+1); Group Vaxelis (2+1); Group Vaxelis (3+1)

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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\*.
• 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.

Sponsors & Collaborators

• MCM Vaccines B.V.: lead
• Merck Sharp & Dohme LLC: collaborator
• Sanofi Pasteur, a Sanofi Company: collaborator

Related 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: 10.1080/21645515.2019.1673119. Epub 2019 Nov 5.

  PMID: 31689166 RESULT

MeSH Terms

Conditions

Hepatitis B; Whooping Cough

Interventions

Blood Specimen Collection; Vaxelis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Vaccine safety was not assessed in the present study.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 3, 2016
• Study Start: April 26, 2016
• Primary Completion: July 29, 2016
• Study Completion: August 1, 2016
• Last Updated: June 9, 2020
• Results First Posted: June 27, 2019

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share