An observational study in Obesity, sponsored by Women's and Children's Hospital, Australia. Active, not recruiting at 1 site in Australia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Women's and Children's Hospital, Australia · Observational
This study has been designed to investigate if:
A clinical observation study to determine whether obesity during pregnancy is associated with altered immunogenicity of influenza and pertussis vaccines during pregnancy. The study will also assess vaccine specific antibody concentrations in cord blood collected from vaccinated women at the time of delivery to estimate any effect of obesity on transplacental transfer of antibodies and will measure and compare cytokine profiles between obese and non-obese participants to determine any correlation with immune responses. This study will enrol 150 pregnant women (50 obese and 100 non-obese) during 2017-2019 to receive a recommended, licensed influenza vaccine (FluQuadri) as well as pertussis vaccination (Adacel) for women enrolled in their third trimester, as part of routine antenatal care. Local and systemic adverse events will be captured using a 7 day diary card and unexpected or serious adverse events will be recorded for the duration of the study. Blood samples will be collected to measure antigen specific vaccine antibody responses. The proportion of influenza vaccine recipients achieving seroprotective antibody titres at 4 weeks post vaccination and persisting at 6 months post vaccination be compared between obese and non-obese recipients.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 73 is below the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Women's and Children's Hospital, Australia is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
A total of 150 healthy pregnant women
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
150 participants (pregnant women at least 18 years of age and meeting eligibility criteria) will be enrolled and administered the FluQuadri, the quadrivalent influenza vaccine which will be administered by single-dose intramuscular injection. Single-dose intramuscular injection of Adacel - DTP vaccine (multiple actives) will also be administered to all enrolled pregnant women who are at gestation 28 weeks or greater at the time of enrolment. Where the vaccines are to be co-administered, FluQuadri will be administered into the dominant arm and Adacel into the non-dominant arm. Pregnant women will be at a gestation of 20 weeks or greater at the time of enrolment. The vaccines administered are currently licensed and recommended in Australia to be given during pregnancy.
Biological: Quadrivalent Influenza Vaccine · Biological: DTP Vaccine (Multiple Actives)
Inactivated quadrivalent influenza vaccine that is used for active immunisation against influenza A, B virus strains (contained in vaccine). Single dose administration by intramuscular injection to all enrolled pregnant women as part of routine antenatal care.
Also known as: FluQuadri
Pertussis vaccine acellular combined with diphtheria and tetanus toxoids. Single dose administration by intramuscular injection, to all enrolled pregnant women who are 28 weeks or greater gestation at time of enrolment, as part of routine antenatal care.
Also known as: Adacel
Immunogenicity against the 4 influenza strains included in the 2017-2019 Southern Hemisphere Influenza vaccine pre and post vaccination in obese and non-obese women
1. Hl titres (as measured by Haemagglutination Inhibition Assay). 1. Proportion with antibody titres (HI\>=40) following vaccination.
Time frame: 1 month post vaccination
Antibodies to pertussis antigens
1. antibody titres to PRN, PT, FHA (measured by ELISA)
Time frame: 1 month post vaccination compared with baseline (pre vaccination).
Persistence of antibodies to pertussis antigens
1. antibody titres to PRN, PT, FHA (measured by ELISA)
Time frame: 6 months post vaccination.
Persistence of antibodies to the 4 influenza strains included in the 2017-2019
1. Hl titres (as measured by Haemagglutination Inhibition Assay). 1. Proportion with antibody titres (HI\>=40) following vaccination.
Time frame: 6 months post vaccination
Serum cytokines
Serum cytokine (TNF, IL6, IFNg) concentration (as measured by flow cytometry/ bead array).
Time frame: 1 month post vaccination
Serum cytokines
Serum cytokine (TNF, IL6, IFNg) concentration (as measured by flow cytometry/ bead array)
Time frame: 6 month post vaccination.
birthweight
weight in grams
Time frame: delivery of infant
haemagglutination Inhibition Antibody Titres in cord blood
HI Titre (as measured by Haemagglutination Inhibition Assay)
Time frame: at delivery of infant
Plan to share: No — Individual participant data (IPD) will not be made available to share with other researchers
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Women's and Children's Hospital, Australia