Effectiveness of Trivalent Inactivated Influenza Maternal Vaccination Among Pregnant Women and Their Newborns in South Africa

Launched by NATIONAL INSTITUTE FOR COMMUNICABLE DISEASES, SOUTH AFRICA · Jun 3, 2015

Keywords

ClinConnect Summary

Study design Investigators will conduct a vaccination campaign amongst pregnant women in different areas of South Africa and monitor the effectiveness of the programme. Investigators will then use an unmatched case-control study design.

Vaccination campaigns will be conducted in clinics with active promotion of influenza vaccination. Posters will be placed in clinics recommending influenza vaccination for pregnant women and health education material will be provided. Vaccines will be administered by clinic staff through routine services as vaccination is the recommended standard of care. D...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Cases and controls will meet the following inclusion criteria:
• • 1. Child admitted to the medical wards at designated surveillance hospitals aged \<6 months on day of hospital admission
• • 2. Mother was eligible to receive influenza vaccination during pregnancy (i.e. pregnant from \~April onwards but actual date will be determined based on actual campaign dates and resident in the area where vaccination was offered)
• • 3. Nasopharyngeal aspirate collected and influenza rRT-PCR result available
• • 4. Documented HIV and HIV-exposure status or consent to child and maternal HIV testing (for the endpoint of HIV-status specific VE only)
• • 5. Consent to inclusion in the study
• • Study enrolment will occur as follows. Study nurses will review all hospital admissions (paediatric medical and sleep over wards) to study hospitals each day to identify any children meeting study case definitions. Parents or guardians of eligible patients will be approached for enrolment into the case-control study. Parents or guardians will be asked if study staff can collect a nasopharyngeal aspirate specimen from the child. In addition, they will be asked to participate in an interview consisting of a list of standardised questions. Additional information will be obtained from hospital records. If not already tested for HIV by the ward doctors, HIV testing with pre- and post-test counselling will be offered to children and mothers to determine child's HIV and HIV-exposure status.
• • A register of all patients approached for enrolment but declining study inclusion and reasons for non-enrolment will be complied.
• • Identification and enrolment of cases and controls for the estimation of VE against adverse birth outcomes (prematurity, LBW, SGA and stillbirth)
• Study staff will review all children born at hospitals with maternity wards described in section 9.2 (Study setting and Population 2nd last paragraph) during and up to three months after the influenza season (from May to December each year). Cases and controls will meet the following inclusion criteria:
• • 1. Child born at designated surveillance hospitals
• • 2. Mother was eligible to receive influenza vaccination during pregnancy (i.e pregnant from \~April onwards but actual date will be determined based on actual campaign dates and resident in the area where vaccination was offered)
• • 3. Data on birth outcomes (preterm birth, LBW and SGA) available
• • 4. Documented evidence of maternal TIV vaccination status able to be ascertained
• • 5. Documented HIV and HIV-exposure status or consent to child and maternal HIV testing (for the endpoint of HIV-status specific VE only)
• • 6. Consent to inclusion in the study
• • Study staff will review all babies born at each hospital each day. Gestational age will be ascertained based on dates using the Ballard system. If the investigators have sufficient data, investigators will explore different cut-off gestational age values for the analysis of preterm birth.
• Exclusion Criteria:
• • - Hospitalised children \<6 months
• • Children whose mothers were not resident in the area where vaccination was offered during the period of the vaccination campaign.
• • Previous inclusion as a case or control Adverse birth outcomes
• • Babies with unavailable data on birth outcomes.
• • Children whose mothers were not resident in the area where vaccination was offered during the period of the vaccination campaign.