Effectiveness of Trivalent Inactivated Influenza Maternal Vaccination Among Pregnant Women and Their Newborns in South Africa
NCT ID: NCT02465190
Last Updated: 2015-06-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Total Enrollment
175 participants
Study Classification
OBSERVATIONAL
Study Start Date
2015-06-30
Study Completion Date
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Influenza Vaccine Trial in HIV Uninfected Pregnant Women
NCT01306669
Influenza
COMPLETED
PHASE3
Inactivated Influenza Vaccine Effectiveness in Tropical Africa
NCT00893906
Influenza
COMPLETED
PHASE4
2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women
NCT01173211
Influenza
COMPLETED
PHASE2
Influenza Vaccine in HIV Infected Children
NCT00883012
Influenza With Pneumonia, Influenza Virus Identified
COMPLETED
PHASE4
Maternal Flu Vaccine Trial in Bamako, Mali
NCT01430689
Influenza
COMPLETED
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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. Dedicated study staff (research assistants) will be placed in each clinic offering vaccination. These staff will assist clinic staff with management of influenza vaccine supplies and documentation of influenza vaccination status in patient records. Vaccination status will be documented in the mother's antenatal records. Investigators will visit all the facilities in the area serving the surveillance hospital and conduct staff training in the facilities where babies are delivered to enter maternal influenza immunization status on the child's vaccination card at the time of administration of the birth dose of polio vaccine.
Identification and enrolment of cases and controls for the estimation of VE against laboratory-confirmed influenza-associated hospitalised illness in infants\<6 months of age overall and by HIV status Cases and controls will be identified through active sentinel surveillance for hospitalised medical illness of any diagnosis amongst children aged \<6 months. Hospitals where surveillance will be conducted will be large hospitals serving the communities in which the antenatal TIV campaign will be conducted. Investigators will conduct ongoing active surveillance with consecutive patient selection until the required sample size is reached.
Identification and enrolment of cases for monitoring adverse events Dedicated study staff will conduct an information session with women selected for enrolment. These women will be asked for written informed consent prior to participation and non-participation will not affect a woman's eligibility to receive vaccine. Following vaccination administered by the nurse, as per the Department of Health schedule, demographic information, medical history, obstetric history and contact details will be collected from each participant by structured interview. Immediate reactions to the vaccine will be recorded at the time of interview. A separate aide de memoire diary will then be given to each participant. This diary will assist the women to record symptoms experienced in the seven days following vaccination. The symptoms listed will be based on standard collection tool.
Data collection Hospitalised children \<6 months For hospitalised children \<6 months of age, epidemiologic data will be collected from a parent or caregiver interview, if possible, as well as review of medical and vaccination records of mother (antenatal cards, maternal in-patient cards and antenatal clinic registers) and baby (Road-to-Health cards and clinic registers). Information gathered will include: demographics of mother and baby (age, sex, race), medical history of baby (premature birth, congenital illnesses such congenital heart or lung disease, immunosuppressive or other chronic illness), recent infections, recent antimicrobial use, household characteristics (residence type and number of rooms, number of persons and their ages, questions related to socioeconomic status, exposure to tobacco smoke and indoor air pollution), child-care centre attendance, breast feeding and vaccination history. It will also request educational level of the parent or guardian and if adults or other children in the household had received pneumococcal or influenza vaccines. Information on HIV status will include whether the mother was tested for HIV during pregnancy and her HIV status if tested, whether the patient has been previously tested for HIV and results of such tests, history of underlying illness and previous HIV-associated diagnosis. Nutritional status of the child will be evaluated measuring weight (in kilograms) and length (in centimetres) at the time of admission. If the parent or guardian has a written vaccination record for the case or control child, names, batch numbers and dates of vaccines will be recorded (see determination of vaccination status below). For issues that may change with time (e.g. exposure to cigarette smoke, breastfeeding, day-care attendance), the questions will focus on the 4 weeks (as in 30 or 31 days) before illness.
Adverse birth outcomes For the effectiveness against adverse birth outcomes (prematurity, LBW and SGA) epidemiologic data will primarily be collected from birth records and maternal antenatal records. Information gathered will include: demographics of mother and baby (age (of mother), sex, race), household characteristics (residence type and number of rooms, number of persons and their ages, questions related to socioeconomic status. It will also request educational level of the parent or guardian. Information on HIV status will include whether the mother was tested for HIV during pregnancy and her HIV status if tested. The baby's birthweight and gestational age will be evaluated from delivery and antenatal records. Birthweight (in kilograms) and length (in centimetres) will be documented.
Hospitalised pregnant women and postpartum women, ≥18 years Epidemiologic, clinical presentation, laboratory data as well as information on hospital course will be collected from enrolled patients. A case investigation form will be completed by structured interview. Information gathered will include: demographics (age, sex, race), presenting symptoms, medical history (lung disease, immunosuppressive or other chronic illness including cardiac diseases, chronic renal diseases, diabetes mellitus and similar metabolic disorders), previous hospital admissions, recent infections, recent antimicrobial use, household characteristics (residence type and number of rooms, number of persons and their ages, questions related to socioeconomic status, exposure to tobacco smoke and indoor air pollution) and data on current and previous influenza vaccination. Information on HIV status will include current HIV status and whether the patient has been previously tested for HIV and results of such tests, previous HIV-associated diagnosis, HIV staging. Obesity evaluated measuring weight (in kilograms) and length (in centimetres) at the time of admission. Medical records will be reviewed for inpatient management (antimicrobial use, influenza antiviral therapy and results of investigations conducted) and outcome (admission to ICU, discharged or died).
Monitoring adverse events The diary will be taken home by the participant. Telephone contact will be made with the participant by a study staff member on day eight (or day 7, 9 or 10 if day 8 falls over a weekend) and the contents of the diary will be recovered telephonically. If the study staff are not able to contact the participant on the first attempt, three further documented attempts will be made to contact the patient. Participants will also be request to return their diaries at their next clinic visit. Participating women will be asked to contact the study team if she is hospitalized for any reason in the seven days post-vaccination. A member of the study team will visit the woman in hospital and, using a predesigned form, collect data on the reason for hospitalization.
Logs recording the enrolled patients with their contact details will be kept at each site. Completed data collection forms will be returned to the data centre at NICD for data capture and storage.
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. Dedicated study staff (research assistants) will be placed in each clinic offering vaccination. These staff will assist clinic staff with management of influenza vaccine supplies and documentation of influenza vaccination status in patient records. Vaccination status will be documented in the mother's antenatal records. Investigators will visit all the facilities in the area serving the surveillance hospital and conduct staff training in the facilities where babies are delivered to enter maternal influenza immunization status on the child's vaccination card at the time of administration of the birth dose of polio vaccine.
Identification and enrolment of cases and controls for the estimation of VE against laboratory-confirmed influenza-associated hospitalised illness in infants\<6 months of age overall and by HIV status Cases and controls will be identified through active sentinel surveillance for hospitalised medical illness of any diagnosis amongst children aged \<6 months. Hospitals where surveillance will be conducted will be large hospitals serving the communities in which the antenatal TIV campaign will be conducted. Investigators will conduct ongoing active surveillance with consecutive patient selection until the required sample size is reached.
Identification and enrolment of cases for monitoring adverse events Dedicated study staff will conduct an information session with women selected for enrolment. These women will be asked for written informed consent prior to participation and non-participation will not affect a woman's eligibility to receive vaccine. Following vaccination administered by the nurse, as per the Department of Health schedule, demographic information, medical history, obstetric history and contact details will be collected from each participant by structured interview. Immediate reactions to the vaccine will be recorded at the time of interview. A separate aide de memoire diary will then be given to each participant. This diary will assist the women to record symptoms experienced in the seven days following vaccination. The symptoms listed will be based on standard collection tool.
Data collection Hospitalised children \<6 months For hospitalised children \<6 months of age, epidemiologic data will be collected from a parent or caregiver interview, if possible, as well as review of medical and vaccination records of mother (antenatal cards, maternal in-patient cards and antenatal clinic registers) and baby (Road-to-Health cards and clinic registers). Information gathered will include: demographics of mother and baby (age, sex, race), medical history of baby (premature birth, congenital illnesses such congenital heart or lung disease, immunosuppressive or other chronic illness), recent infections, recent antimicrobial use, household characteristics (residence type and number of rooms, number of persons and their ages, questions related to socioeconomic status, exposure to tobacco smoke and indoor air pollution), child-care centre attendance, breast feeding and vaccination history. It will also request educational level of the parent or guardian and if adults or other children in the household had received pneumococcal or influenza vaccines. Information on HIV status will include whether the mother was tested for HIV during pregnancy and her HIV status if tested, whether the patient has been previously tested for HIV and results of such tests, history of underlying illness and previous HIV-associated diagnosis. Nutritional status of the child will be evaluated measuring weight (in kilograms) and length (in centimetres) at the time of admission. If the parent or guardian has a written vaccination record for the case or control child, names, batch numbers and dates of vaccines will be recorded (see determination of vaccination status below). For issues that may change with time (e.g. exposure to cigarette smoke, breastfeeding, day-care attendance), the questions will focus on the 4 weeks (as in 30 or 31 days) before illness.
Adverse birth outcomes For the effectiveness against adverse birth outcomes (prematurity, LBW and SGA) epidemiologic data will primarily be collected from birth records and maternal antenatal records. Information gathered will include: demographics of mother and baby (age (of mother), sex, race), household characteristics (residence type and number of rooms, number of persons and their ages, questions related to socioeconomic status. It will also request educational level of the parent or guardian. Information on HIV status will include whether the mother was tested for HIV during pregnancy and her HIV status if tested. The baby's birthweight and gestational age will be evaluated from delivery and antenatal records. Birthweight (in kilograms) and length (in centimetres) will be documented.
Hospitalised pregnant women and postpartum women, ≥18 years Epidemiologic, clinical presentation, laboratory data as well as information on hospital course will be collected from enrolled patients. A case investigation form will be completed by structured interview. Information gathered will include: demographics (age, sex, race), presenting symptoms, medical history (lung disease, immunosuppressive or other chronic illness including cardiac diseases, chronic renal diseases, diabetes mellitus and similar metabolic disorders), previous hospital admissions, recent infections, recent antimicrobial use, household characteristics (residence type and number of rooms, number of persons and their ages, questions related to socioeconomic status, exposure to tobacco smoke and indoor air pollution) and data on current and previous influenza vaccination. Information on HIV status will include current HIV status and whether the patient has been previously tested for HIV and results of such tests, previous HIV-associated diagnosis, HIV staging. Obesity evaluated measuring weight (in kilograms) and length (in centimetres) at the time of admission. Medical records will be reviewed for inpatient management (antimicrobial use, influenza antiviral therapy and results of investigations conducted) and outcome (admission to ICU, discharged or died).
Monitoring adverse events The diary will be taken home by the participant. Telephone contact will be made with the participant by a study staff member on day eight (or day 7, 9 or 10 if day 8 falls over a weekend) and the contents of the diary will be recovered telephonically. If the study staff are not able to contact the participant on the first attempt, three further documented attempts will be made to contact the patient. Participants will also be request to return their diaries at their next clinic visit. Participating women will be asked to contact the study team if she is hospitalized for any reason in the seven days post-vaccination. A member of the study team will visit the woman in hospital and, using a predesigned form, collect data on the reason for hospitalization.
Logs recording the enrolled patients with their contact details will be kept at each site. Completed data collection forms will be returned to the data centre at NICD for data capture and storage.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Influenza Viral Infections
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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)
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.
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)
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.
* 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.
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centers for Disease Control and Prevention
FED
Sponsor Role
collaborator
Bill and Melinda Gates Foundation
OTHER
Sponsor Role
collaborator
National Institute for Communicable Diseases, South Africa
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shabir Madhi, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute for Communicable Diseases
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chris Hani Baragwanath Academic Hospital and National Institute for Communicable Diseases
Johannesburg, Gauteng, South Africa
Site Status
Countries
Review the countries where the study has at least one active or historical site.
South Africa
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MatFluVaccSA_v2_11/03/2015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate.
NCT01985620
UNKNOWN
NA
Safety of H1N1 Influenza Vaccination in Pregnant Women
NCT01842997
COMPLETED
PHASE4
Immunogenicity and Safety of an Inactivated Non-adjuvanted A(H1N1)v Influenza Vaccine in Pregnant Women
NCT01024400
COMPLETED
PHASE2
Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month
NCT01040078
UNKNOWN
PHASE3
Influenza Vaccine in Pregnancy Part 2
NCT00593970
COMPLETED
Influenza Vaccine in Pregnant Women
NCT00905125
COMPLETED
PHASE2
Brief Influenza Vaccine Education to Pregnant Women
NCT01772901
COMPLETED
NA
Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants
NCT05436184
ACTIVE_NOT_RECRUITING
Field Trial of Maternal Influenza Immunization in Asia
NCT01034254
COMPLETED
PHASE3
Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy
NCT04579822
UNKNOWN
Immunogenicity and Safety of Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Adults
NCT00328107
COMPLETED
PHASE2/PHASE3
Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2008/2009
NCT00735410
COMPLETED
PHASE3
Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants
NCT01494740
COMPLETED
PHASE2
A Clinical Trial of an Quadrivalent Inactivated Influenza Vaccine in Healthy Children Aged 6 to 35 Months
NCT05212623
COMPLETED
PHASE1
Trial of Tolerability, Reactogenicity, Safety and Immunogenicity of Flu-M [Inactivated Split Influenza Vaccine] in Pregnant Women
NCT05457894
COMPLETED
PHASE3
Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008
NCT00511914
COMPLETED
PHASE3
H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A H1N1v Vaccination in Pregnant Women
NCT01012557
COMPLETED
NA
An Effectiveness Trial to Evaluate Protection of Children and Pregnant Women by Influenza Vaccine in Rural Bangladesh
NCT04998344
ACTIVE_NOT_RECRUITING
PHASE4
Prospective Cohort Study to Evaluate Safety/Immunogenicity of Butantan Influenza Vaccine in Healthy Adults/Elderly
NCT02313740
COMPLETED
Novartis H1N1 Vaccine in Pregnant Women
NCT00992719
COMPLETED
PHASE2
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
NCT00996307
COMPLETED
PHASE2/PHASE3
The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)
NCT01551810
COMPLETED
PHASE3
Influenza Vaccine in Premature Infants
NCT00455169
COMPLETED
Response to Influenza Vaccine During Pregnancy
NCT03888989
TERMINATED
PHASE1
The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）
NCT01551823
COMPLETED
PHASE3