Efficacy of trivalent influenza vaccine against laboratory-confirmed influenza among young children in a randomized trial in Bangladesh

Melissa A. Rolfes, Doli Goswami, Amina Tahia Sharmeen, Sultana Yeasmin, Nasrin Parvin, Kamrun Nahar, Mustafizur Rahman, Marion Barends, Dilruba Ahmed, Mohammed Ziaur Rahman, Joseph Bresee, Stephen Luby, Lawrence Hale Moulton, Mathuram Santosham, Alicia M. Fry, W Abdullah Brooks

Research output: Contribution to journalArticle

Abstract

Background Few trials have evaluated influenza vaccine efficacy (VE) in young children, a group particularly vulnerable to influenza complications. We aimed to estimate VE against influenza in children aged <2 years in Bangladesh; a subtropical setting, where influenza circulation can be irregular. Methods Children aged 6–23 months were enrolled 1:1 in a parallel, double-blind, randomized controlled trial of trivalent inactivated influenza vaccine (IIV3) versus inactivated polio vaccine (IPV); conducted August 2010–March 2014 in Dhaka, Bangladesh. Children received two pediatric doses of vaccine, one month apart, and were followed for one year for febrile and respiratory illness. Field assistants conducted weekly home-based, active surveillance and ill children were referred to the study clinic for clinical evaluation and nasopharyngeal wash specimen collection. Analysis included all children who received a first vaccine dose and compared yearly incidence of reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza between trial arms. The VE was estimated as 1 − (rate ratio of illness) × 100%, using unadjusted Poisson regression. The trial was registered with ClinicalTrials.gov, number NCT01319955. Results Across four vaccination rounds, 4081 children were enrolled and randomized, contributing 2576 child-years of observation to the IIV3 arm and 2593 child-years to the IPV arm. Influenza incidence was 10 episodes/100 child-years in the IIV3 arm and 15 episodes/100 child-years in the IPV arm. Overall, the VE was 31% (95% confidence interval 18, 42%) against any RT-PCR-confirmed influenza. The VE varied by season, but was similar by influenza type/subtype and participant age and sex. Conclusions Vaccination of young children with IIV3 provided a significant reduction in laboratory-confirmed influenza; however, exploration of additional influenza vaccine strategies, such as adjuvanted vaccines or standard adult vaccine doses, is warranted to find more effective influenza vaccines for young children in low-income countries.

Original languageEnglish (US)
Pages (from-to)6967-6976
Number of pages10
JournalVaccine
Volume35
Issue number50
DOIs
StatePublished - Dec 15 2017

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Bangladesh
Influenza Vaccines
influenza
Human Influenza
vaccines
Vaccines
Inactivated Vaccines
Poliomyelitis
Reverse Transcription
Vaccination
dosage
Specimen Handling
reverse transcriptase polymerase chain reaction
vaccination
Polymerase Chain Reaction
incidence
Incidence
Fever
fever
Randomized Controlled Trials

Keywords

  • Children
  • Clinical trial
  • Influenza
  • Vaccine

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Efficacy of trivalent influenza vaccine against laboratory-confirmed influenza among young children in a randomized trial in Bangladesh. / Rolfes, Melissa A.; Goswami, Doli; Sharmeen, Amina Tahia; Yeasmin, Sultana; Parvin, Nasrin; Nahar, Kamrun; Rahman, Mustafizur; Barends, Marion; Ahmed, Dilruba; Rahman, Mohammed Ziaur; Bresee, Joseph; Luby, Stephen; Moulton, Lawrence Hale; Santosham, Mathuram; Fry, Alicia M.; Brooks, W Abdullah.

In: Vaccine, Vol. 35, No. 50, 15.12.2017, p. 6967-6976.

Research output: Contribution to journalArticle

Rolfes, MA, Goswami, D, Sharmeen, AT, Yeasmin, S, Parvin, N, Nahar, K, Rahman, M, Barends, M, Ahmed, D, Rahman, MZ, Bresee, J, Luby, S, Moulton, LH, Santosham, M, Fry, AM & Brooks, WA 2017, 'Efficacy of trivalent influenza vaccine against laboratory-confirmed influenza among young children in a randomized trial in Bangladesh', Vaccine, vol. 35, no. 50, pp. 6967-6976. https://doi.org/10.1016/j.vaccine.2017.10.074
Rolfes, Melissa A. ; Goswami, Doli ; Sharmeen, Amina Tahia ; Yeasmin, Sultana ; Parvin, Nasrin ; Nahar, Kamrun ; Rahman, Mustafizur ; Barends, Marion ; Ahmed, Dilruba ; Rahman, Mohammed Ziaur ; Bresee, Joseph ; Luby, Stephen ; Moulton, Lawrence Hale ; Santosham, Mathuram ; Fry, Alicia M. ; Brooks, W Abdullah. / Efficacy of trivalent influenza vaccine against laboratory-confirmed influenza among young children in a randomized trial in Bangladesh. In: Vaccine. 2017 ; Vol. 35, No. 50. pp. 6967-6976.
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abstract = "Background Few trials have evaluated influenza vaccine efficacy (VE) in young children, a group particularly vulnerable to influenza complications. We aimed to estimate VE against influenza in children aged <2 years in Bangladesh; a subtropical setting, where influenza circulation can be irregular. Methods Children aged 6–23 months were enrolled 1:1 in a parallel, double-blind, randomized controlled trial of trivalent inactivated influenza vaccine (IIV3) versus inactivated polio vaccine (IPV); conducted August 2010–March 2014 in Dhaka, Bangladesh. Children received two pediatric doses of vaccine, one month apart, and were followed for one year for febrile and respiratory illness. Field assistants conducted weekly home-based, active surveillance and ill children were referred to the study clinic for clinical evaluation and nasopharyngeal wash specimen collection. Analysis included all children who received a first vaccine dose and compared yearly incidence of reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza between trial arms. The VE was estimated as 1 − (rate ratio of illness) × 100{\%}, using unadjusted Poisson regression. The trial was registered with ClinicalTrials.gov, number NCT01319955. Results Across four vaccination rounds, 4081 children were enrolled and randomized, contributing 2576 child-years of observation to the IIV3 arm and 2593 child-years to the IPV arm. Influenza incidence was 10 episodes/100 child-years in the IIV3 arm and 15 episodes/100 child-years in the IPV arm. Overall, the VE was 31{\%} (95{\%} confidence interval 18, 42{\%}) against any RT-PCR-confirmed influenza. The VE varied by season, but was similar by influenza type/subtype and participant age and sex. Conclusions Vaccination of young children with IIV3 provided a significant reduction in laboratory-confirmed influenza; however, exploration of additional influenza vaccine strategies, such as adjuvanted vaccines or standard adult vaccine doses, is warranted to find more effective influenza vaccines for young children in low-income countries.",
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T1 - Efficacy of trivalent influenza vaccine against laboratory-confirmed influenza among young children in a randomized trial in Bangladesh

AU - Rolfes, Melissa A.

AU - Goswami, Doli

AU - Sharmeen, Amina Tahia

AU - Yeasmin, Sultana

AU - Parvin, Nasrin

AU - Nahar, Kamrun

AU - Rahman, Mustafizur

AU - Barends, Marion

AU - Ahmed, Dilruba

AU - Rahman, Mohammed Ziaur

AU - Bresee, Joseph

AU - Luby, Stephen

AU - Moulton, Lawrence Hale

AU - Santosham, Mathuram

AU - Fry, Alicia M.

AU - Brooks, W Abdullah

PY - 2017/12/15

Y1 - 2017/12/15

N2 - Background Few trials have evaluated influenza vaccine efficacy (VE) in young children, a group particularly vulnerable to influenza complications. We aimed to estimate VE against influenza in children aged <2 years in Bangladesh; a subtropical setting, where influenza circulation can be irregular. Methods Children aged 6–23 months were enrolled 1:1 in a parallel, double-blind, randomized controlled trial of trivalent inactivated influenza vaccine (IIV3) versus inactivated polio vaccine (IPV); conducted August 2010–March 2014 in Dhaka, Bangladesh. Children received two pediatric doses of vaccine, one month apart, and were followed for one year for febrile and respiratory illness. Field assistants conducted weekly home-based, active surveillance and ill children were referred to the study clinic for clinical evaluation and nasopharyngeal wash specimen collection. Analysis included all children who received a first vaccine dose and compared yearly incidence of reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza between trial arms. The VE was estimated as 1 − (rate ratio of illness) × 100%, using unadjusted Poisson regression. The trial was registered with ClinicalTrials.gov, number NCT01319955. Results Across four vaccination rounds, 4081 children were enrolled and randomized, contributing 2576 child-years of observation to the IIV3 arm and 2593 child-years to the IPV arm. Influenza incidence was 10 episodes/100 child-years in the IIV3 arm and 15 episodes/100 child-years in the IPV arm. Overall, the VE was 31% (95% confidence interval 18, 42%) against any RT-PCR-confirmed influenza. The VE varied by season, but was similar by influenza type/subtype and participant age and sex. Conclusions Vaccination of young children with IIV3 provided a significant reduction in laboratory-confirmed influenza; however, exploration of additional influenza vaccine strategies, such as adjuvanted vaccines or standard adult vaccine doses, is warranted to find more effective influenza vaccines for young children in low-income countries.

AB - Background Few trials have evaluated influenza vaccine efficacy (VE) in young children, a group particularly vulnerable to influenza complications. We aimed to estimate VE against influenza in children aged <2 years in Bangladesh; a subtropical setting, where influenza circulation can be irregular. Methods Children aged 6–23 months were enrolled 1:1 in a parallel, double-blind, randomized controlled trial of trivalent inactivated influenza vaccine (IIV3) versus inactivated polio vaccine (IPV); conducted August 2010–March 2014 in Dhaka, Bangladesh. Children received two pediatric doses of vaccine, one month apart, and were followed for one year for febrile and respiratory illness. Field assistants conducted weekly home-based, active surveillance and ill children were referred to the study clinic for clinical evaluation and nasopharyngeal wash specimen collection. Analysis included all children who received a first vaccine dose and compared yearly incidence of reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza between trial arms. The VE was estimated as 1 − (rate ratio of illness) × 100%, using unadjusted Poisson regression. The trial was registered with ClinicalTrials.gov, number NCT01319955. Results Across four vaccination rounds, 4081 children were enrolled and randomized, contributing 2576 child-years of observation to the IIV3 arm and 2593 child-years to the IPV arm. Influenza incidence was 10 episodes/100 child-years in the IIV3 arm and 15 episodes/100 child-years in the IPV arm. Overall, the VE was 31% (95% confidence interval 18, 42%) against any RT-PCR-confirmed influenza. The VE varied by season, but was similar by influenza type/subtype and participant age and sex. Conclusions Vaccination of young children with IIV3 provided a significant reduction in laboratory-confirmed influenza; however, exploration of additional influenza vaccine strategies, such as adjuvanted vaccines or standard adult vaccine doses, is warranted to find more effective influenza vaccines for young children in low-income countries.

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