NCT03697798

Brief Summary

This study aims to investigate the effects of aP booster vaccination in children, young adults and elderly on the (long-term) immune response to B. pertussis in three European countries with a different epidemiological background and primary vaccination schedule for pertussis.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2018

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

April 23, 2018

Last Update Submit

January 7, 2021

Conditions

Pertussis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of pertussis toxin-specific IgG antibody levels to 28 days after vaccination

    28 days

Secondary Outcomes (7)

  • Amount of pertussis toxin (PT) specific IgG antibody one year after vaccination with Boostrix-IPV

    1 year

  • Change from baseline in pertussis toxin (PT) specific IgG-subclasses and avidity levels to 28 days and 1 year after vaccination with Boostrix-IPV

    28 days and 1 year

  • Change from baseline of antigen-specific IgG antibody levels against other pertussis vaccine antigens (such as FHA) and non-pertussis vaccine antigens (such as diptheria and tetanus toxoid) to 28 days and 1 year after vaccination with Boostrix-IPV

    28 days and 1 year

  • Change from baseline of functional pertussis-specific antibody levels to 28 days and 1 year after vaccination with Boostrix-IPV

    28 days and 1 year

  • Change from baseline of B cell responses against Bordetella pertussis vaccine proteins after vaccination with Boostrix-IPV

    7 days, 28 days and 1 year

  • +2 more secondary outcomes

Study Arms (4)

Children aged between 7-10 years of age

ACTIVE COMPARATOR

Healthy children from 7 up to 10 years of age, determined by date of birth (dd/mm/yyyy), at the time of the first visit. Male + female, approximately equally distributed, n = 36 in each country. They will receive Boostrix®-IPV combination vaccine.

Biological: Boostrix®-IPV combination vaccine

Children aged between 11-15 years of age

ACTIVE COMPARATOR

Healthy children from 11 up to 15 years of age, determined by date of birth (dd/mm/yyyy), at the time of the first visit. Male + female, approximately equally distributed, n = 36 in each country aiming for comparable numbers of participants with aP vs wP vaccination background. They will receive Boostrix®-IPV combination vaccine.

Biological: Boostrix®-IPV combination vaccine

Adults aged between 20-34 years of age

ACTIVE COMPARATOR

Healthy young adults from 20 up to 34 years of age, determined by date of birth (dd/mm/yyyy), at the time of the first visit. Male + female, approximately equally distributed, n = 25 in each country. They will receive Boostrix®-IPV combination vaccine.

Biological: Boostrix®-IPV combination vaccine

Adults aged between 60-70 years of age

ACTIVE COMPARATOR

Older adults from 60 up to 70 years of age determined by date of birth (dd/mm/yyyy), at the time of the first visit. Male + female, approximately equally distributed, n = 25 in each country. They will receive Boostrix®-IPV combination vaccine.

Biological: Boostrix®-IPV combination vaccine

Interventions

Boostrix®-IPV combination vaccineBIOLOGICAL

A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.

Adults aged between 20-34 years of ageAdults aged between 60-70 years of ageChildren aged between 11-15 years of ageChildren aged between 7-10 years of age

Eligibility Criteria

Age7 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Normal general health
  • Within the right age group for the cohort
  • Received all regular vaccines for their age group according to the Dutch NIP, UK NIP or Finnish NIP; a copy of the vaccination booklet will be included in the participant's documents. If booklet is not available for cohorts A, B and C, vaccination status will be checked although, for cohort C and D this booklet might not be available due to their age;
  • Provision of written informed consent
  • Willing to adhere to the protocol and be available during the study period.

You may not qualify if:

  • Chronic infection
  • Known or suspected immune deficiency;
  • History of any neurologic disorder, including epilepsy;
  • Previous administration of serum products (including immunoglobulins) within 6 months before vaccination and blood sampling;
  • Known and/or suspected allergy to any of the vaccine components (by medical history);
  • Occurrence of a serious adverse events (SAEs) after primary DTwP-IPV vaccination, DTaP-IPV vaccination or any other vaccination (by medical history);
  • Children between 8 and 10 years of age eligible for cohort A in the Netherlands who have already received the diphtheria and tetanus toxoid vaccine (DT)-IPV booster vaccination according to Dutch NIP around 9 years of age;
  • Mixed wP and aP priming within a participant, cohort B;
  • If a participant has a severe acute (infectious) illness or fever (\>38°C) within 14 days prior to T0, participation will be postponed or cancelled. In case the participant has fever within 2 days before sampling at T4 or T5, the appointment will be postponed for 4 days, if possible.
  • Antibiotic use within 14 days of enrolment.
  • Any vaccination within a month before enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Turku

Turku, FI-20014, Finland

Location

Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM)

Bilthoven, 3721 MA, Netherlands

Location

Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Dr Marlies van Houten

    Spaarne Hospital, Hoofddorp

    PRINCIPAL INVESTIGATOR

  • Prof. dr. Jussi Mertsola

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

  • Dr Dominic Kelly

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

October 5, 2018

Study Start

April 18, 2018

Primary Completion

January 14, 2020

Study Completion

January 14, 2020

Last Updated

January 8, 2021

Record last verified: 2021-01

Locations

GB(1)NL(1)FI(1)