Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02408926
• Date of registration: 23/03/2015
• Prospective Registration: Yes
• Primary sponsor: Universiteit Antwerpen
• Public title: Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand
• Scientific title: Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand
• Date of first enrolment: April 2015
• Target sample size: 370
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02408926
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Thailand

Contacts

• Name: Elke Leuridan, MD PhD
• Affiliation: Universiteit Antwerpen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Willing to be immunized with a pertussis containing vaccine during pregnancy

- Intend to be available for follow-up visits and phone call through 19 months
postpartum

- Willing to have infant immunized with a pertussis containing vaccine at 2, 4, 6 months
and 18 months of age according to EPI (Expanded Programme of Immunization) and
receiving (randomized) either acellular pertussis (aP) (study vaccine) or a whole cell
pertussis (wP) vaccine. Consent for participation of the child is needed by both
married parents or by a single unmarried other.

- At low risk for pregnancy related complications as determined by the investigator and
a second trimester ultrasound with no significant abnormalities.

Exclusion Criteria:

Pregnant subjects

- Multiple pregnancies

- Serious obstetrical risk

- Serious underlying medical condition

- Significant mental illness

- History of febrile illness (greater than or equal to 38°C) within the past 72 hours
before injection

- Previous severe reaction to any vaccine

- Receipt of tetanus-diphtheria toxoid immunization within the past 1 month Receipt of
an pertussis containing vaccine (Tdap) in the last 5 years

- Receipt of a vaccine, blood product (excluding Rhogam) within the 4 weeks prior to
injection through 4 weeks following injection and IVIG (Intravenous Immunoglobulins)
within 12 weeks period. One month interval should be respected with another vaccine
(except influenza) in orde to evaluate Adverse events following one or both vaccines
(fever, local symptoms)

- Receipt of an experimental drug during pregnancy

- Anything in the opinion of the investigator that would prevent women from completing
the study or put the woman at risk

Infants

- Preterm delivery before 37 weeks of gestation

- Serious underlying medical condition

- Children suffering from primary humoral immune disorders; suffering from primary
cellular immune deficiencies and disorders from the complete cascade

- No informed consent from one or both married parents

- Severe reactions to any vaccine

- Anything in the opinion of the investigator that would prevent children from
completing the study or put the child at risk



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pertussis

Intervention(s)

Biological: Boostrix

Biological: Quinvaxem

Biological: Infanrix hexa

Biological: OPV

Primary Outcome(s)

kinetics of Pertactin (Prn) IgG titers in infants [Time Frame: from birth until 19 months of age]

kinetics of Pertussis toxin (PT) IgG titers in infants [Time Frame: from birth until 19 months of age]

kinetics of Filamentous haemagglutinin (FHA) IgG titers in infants [Time Frame: from birth until 19 months of age]

Secondary Outcome(s)

Functionality of the anti-PT IgG antibodies in the infants after vaccination assessed with a newly validated luminescence based assay [Time Frame: At month 7 and month 19]

Functionality of the maternal anti-PT IgG antibodies in the infants as assessed with a newly validated luminescence based assay [Time Frame: At birth]

Efficacy of the transplacental transport of IgG as assessed by the ratio of cord and maternal titers of IgG antibodies [Time Frame: Birth]

Secondary ID(s)

cev002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Chulalongkorn University

Institut Pasteur de Lille

Thrasher Research Fund