Skip to main content
OpenTrials
Completed

NCT Number: NCT02759354

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)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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*.
  • Participant who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion*.
  • 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.
  • 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.

Treatment and study plan

blood sample

Other

Blood sample at approx. 4 years of age

Other names: Vaxelis®, INFANRIX® hexa

Primary outcomes

  1. Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg)

    Time frame: Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule)

    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.

  2. Percentage of Participants Responding to Pertussis Toxin

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

    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.

  3. Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin

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

    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.

  4. Percentage of Participants Responding to Pertussis Pertactin

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

    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.

  5. Percentage of Participants Responding to Pertussis Fimbriae

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

    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.

Secondary outcomes

  1. Geometric Mean Concentration of Antibodies to HBsAg

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

    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.

  2. Geometric Mean Concentration of Antibodies to Pertussis Toxin

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

    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.

  3. Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin

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

    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.

  4. Geometric Mean Concentration of Antibodies to Pertussis Pertactin

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

    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.

  5. Geometric Mean Concentration of Antibodies to Pertussis Fimbriae

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

    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.

Other outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

MCM Vaccines B.V.

Industry

Collaborators

  • Merck Sharp & Dohme LLC
  • Sanofi Pasteur, a Sanofi Company

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 3, 2016
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.