Investigating the risk of adverse maternal and infant perinatal outcomes following vaccination during pregnancy, Australia 1994-2015.

Retrospective cohort analysis to investigate the risk of adverse maternal and infant perinatal outcomes following vaccination during pregnancy, Australia 1994-2015.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12617001082392

Enrollment

85000

Registered

2017-07-26

Start date

2017-02-10

Completion date

2017-02-10

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Retrospective descriptive analysis of the safety of maternal vaccination utilising 4 datasets: ‘FluMum’, ‘PneuMum’, ‘1+1HS’ and a population based de-identified NT birth cohort. Combined datasets ~85,000 mother-infant pairs, of which ~30% identify as Aboriginal and/or Torres Strait Islander. There is no active participant recruitment, no blood tests or specimen collections and no direct contact with any participants. Results will be presented as large aggregate data with no potential for identifying information. Results will contribute novel information on adverse maternal and infant perinatal outcomes over a 21 year period (1994-2015) .We will calculate ‘Observed-to-Expected’ ratios to describe the risk of an adverse outcome occurring following maternal vaccination in pregnancy with influenza, pertussis or pneumococcal vaccines.

Interventions

Retrospective cohort analyses of four separate datasets where data collection is complete. Written, informed consent was obtained from each individual participant in each study. 1. 'FluMum' (NHMRC Project Grant no.APP1020035, HREC Reference Number: 2012-1744) . Data collection occurred from 01 April 2012- 30 June 2015. 2.'PneuMum' (HREC Reference Number: 05-52). Data collection occurred from August 2006 and January 2011. Exact dates of data collection not provided due to potentially identifiable information of Indigenous participants. 3. '1+1HS' (HREC Reference Number: 2016-2710) studies. Data collection occurred from 2004-2006 and 2009-2011. Exact dates of data collection not provided due to potentially identifiable information of Indigenous participants. Participants were interviewed by trained research staff using a detailed structured questionnaire at birth and then at 6 months post-partum. Exposures will be inactivated influenza, dTpa(pertussis) and 23v polysaccharide pneumococcal vaccines in pregnancy compared to unvaccinated pregnant women.

Eligibility

Sex/Gender

All

Healthy volunteers

Yes

Inclusion criteria

i. Mothers – any pregnancy greater than or equal to 20 weeks gestation ii. Infants born greater than or equal to 20 weeks gestation and/or weighing greater than or equal to 400grams iii. Singleton infants from singleton pregnancies

Exclusion criteria

i. Non-pregnant women ii. Multiparous pregnancies (pregnancies where the woman is carrying more than one fetus) iii. Infants who are a twin, triplet or other multiple birth iv. Participants in the ‘FluMum’, ‘PneuMum’ and ‘1+1HS’ datasets where maternal vaccination status is unknown

Outcome results