NCT02465190|Unknown
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Sponsor study identifier
observational
175
1 country
1
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 28, 2015
Actual (reported)June 2015
Date type not reportedThis date has not been verified as actual or estimated.
June 8, 2015
Actual (reported)September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
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.
Chris Hani Baragwanath Academic Hospital and National Institute for Communicable Diseases
Johannesburg, Gauteng, South Africa
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.
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.
Nasopharyngeal swabs and aspirates
Shabir Madhi, PhD
National Institute for Communicable Diseases
First Submitted
April 28, 2015
First Posted
June 8, 2015
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Estimated (date passed)Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 8, 2015
Record last verified: 2015-06
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