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

NCT02465190 | Unknown

• 1 other identifier: MatFluVaccSA_v2_11/03/2015
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

This is a case-control study embedded in a surveillance system to determine the effectiveness of antenatal maternal influenza vaccination against laboratory-confirmed influenza-associated hospitalised illness in infants \<6 months of age.

Conditions

Influenza Viral Infections

Keywords

Vaccine; Effectiveness; Influenza

Outcome Measures

Primary Outcomes (1)

• Laboratory-confirmed influenza-associated hospitalised illness in infants<6 months of age

  hospitalised infants up to 6 months of age, whose mothers were eligible to have received influenza vaccination and born between March and August.

Secondary Outcomes (8)

• Laboratory-confirmed influenza-associated hospitalised illness in infants<6 months of age by HIV exposure status

  hospitalised infants up to 6 months of age, whose mothers were eligible to have received influenza vaccination and born between March and August.

• Laboratory-confirmed influenza-associated hospitalised illness in pregnant women

  Pregnant woman admitted to the obstetric or gynaecology wards with cardio-respiratory illness and eligible to have received influenza vaccination for up to 42 days postpartum

• Laboratory-confirmed influenza-associated hospitalised illness in post-partum women

  up to 42 days postpartum woman admitted to the obstetric or gynaecology wards with cardio-respiratory illness and eligible to have received influenza vaccination.

• Occurrence and severity of adverse events following immunization with seasonal influenza vaccine in pregnant women

  Pregnant woman admitted to the obstetric or gynaecology wards with cardio-respiratory illness and eligible to have received influenza vaccination for up to 42 days postpartum

• Low birth weight

  hospitalised infants up to 6 months of age, whose mothers were eligible to have received influenza vaccination and born between March and August.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will be conducted in Gauteng Province and Western Cape Province in South Africa. Both are urban areas with good access to hospital care for mothers and infants. Babies born to women who were 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) will be the study population. Investigators will conduct surveillance for hospitalisations amongst infants \<6 months of age. Investigators will conduct surveillance for adverse birth outcomes at identified hospitals. Investigators will conduct surveillance for LRTI hospitalisations among pregnant and postpartum women.

You may qualify if:

• Child admitted to the medical wards at designated surveillance hospitals aged \<6 months on day of hospital admission
• 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)
• Nasopharyngeal aspirate collected and influenza rRT-PCR result available
• Documented HIV and HIV-exposure status or consent to child and maternal HIV testing (for the endpoint of HIV-status specific VE only)
• 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.
• Identification and enrolment of cases and controls for the estimation of VE against adverse birth outcomes (prematurity, LBW, SGA and stillbirth)
• Child born at designated surveillance hospitals
• 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)
• Data on birth outcomes (preterm birth, LBW and SGA) available
• Documented evidence of maternal TIV vaccination status able to be ascertained
• Documented HIV and HIV-exposure status or consent to child and maternal HIV testing (for the endpoint of HIV-status specific VE only)
• 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.

You may not qualify if:

• \- Hospitalised children \<6 months
• Children whose mothers were not resident in the area where vaccination was offered during the period of the vaccination campaign.
• 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.

Sponsors & Collaborators

• National Institute for Communicable Diseases, South Africa: lead
• Centers for Disease Control and Prevention: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Chris Hani Baragwanath Academic Hospital and National Institute for Communicable Diseases

Johannesburg, Gauteng, South Africa

Location

Related Publications (3)

• Omer SB, Clark DR, Madhi SA, Tapia MD, Nunes MC, Cutland CL, Simoes EAF, Aqil AR, Katz J, Tielsch JM, Steinhoff MC, Wairagkar N; BMGF Supported Maternal Influenza Immunization Trials Investigators Group. Efficacy, duration of protection, birth outcomes, and infant growth associated with influenza vaccination in pregnancy: a pooled analysis of three randomised controlled trials. Lancet Respir Med. 2020 Jun;8(6):597-608. doi: 10.1016/S2213-2600(19)30479-5.

  PMID: 32526188 DERIVED

• Clark DR, Omer SB, Tapia MD, Nunes MC, Cutland CL, Tielsch JM, Wairagkar N, Madhi SA; for BMGF Supported Maternal Influenza Immunization Trials Investigators Group. Influenza or Meningococcal Immunization During Pregnancy and Mortality in Women and Infants: A Pooled Analysis of Randomized Controlled Trials. Pediatr Infect Dis J. 2020 Jul;39(7):641-644. doi: 10.1097/INF.0000000000002629.

  PMID: 32379201 DERIVED

• Omer SB, Clark DR, Aqil AR, Tapia MD, Nunes MC, Kozuki N, Steinhoff MC, Madhi SA, Wairagkar N; for BMGF Supported Maternal Influenza Immunization Trials Investigators Group. Maternal Influenza Immunization and Prevention of Severe Clinical Pneumonia in Young Infants: Analysis of Randomized Controlled Trials Conducted in Nepal, Mali and South Africa. Pediatr Infect Dis J. 2018 May;37(5):436-440. doi: 10.1097/INF.0000000000001914.

  PMID: 29443825 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swabs and aspirates

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Shabir Madhi, PhD

  National Institute for Communicable Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheryl Cohen, MBBCh

CONTACT

+27113866593; cherylc@nicd.ac.za

Marta Nunes, Phd

CONTACT

+27119834262; nunesm@rmpru.co.za

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: June 8, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

ZA (1)