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Influenza HumanPhase 3Mothers'GiftNCT01034254

Field Trial of Maternal Influenza Immunization in Asia

A Phase 3 study testing influenza vaccine in people with Influenza Human, run by Children's Hospital Medical Center, Cincinnati at 1 site in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project is designed to assess the efficacy of immunizing women during pregnancy with influenza vaccine on the health of these women during their pregnancy and for 6 months post-partum as well as on the health of their newborn infants during the first 6 months of life. Read more about this study

Who is it for?
Ages 15 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Influenza Human
What is being tested?
influenza vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,693 participants
Where
1 siteNepal
Study dates
Nov 2010to Oct 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • mid to late pregnancy

Who cannot join

  • do not intend to deliver in the study area
  • previous pregnancy in this study

Trial locations and contacts

1 site in 1 country.

Nepal1 site

  • Institute of Medicine, Tribhuvan Univerisity

    Kathmandu

Other trials in Nepal

About this study

This project is designed to assess the efficacy of immunizing women during pregnancy with influenza vaccine on the health of these women during their pregnancy and for 6 months post-partum as well as on the health of their newborn infants during the first 6 months of life. It will be conducted in Sarlahi District in southern Nepal, a rural area where a number of large scale randomized trials have been conducted over the past 20 years.

Read the detailed description

This is a community-based, placebo-controlled, individually randomized trial in trial among women who are or who become pregnant in 9 Village Development Committees in Sarlahi District, Nepal. The study population for this trial will include all women who are identified as pregnant with gestational age between 17 and 34 weeks gestation during a 12-month period in 9 Village Development Committees (VDC) of Sarlahi District, Nepal. The 9 VDCs include: Dhungre Khola, Karmaiya, Hariaun, Ghurkauli, Sasapur, Netraganj, Lalbandi, Jabdi, and Raniganj.

The vaccine that will be given will be the most current vaccine at the time of subject enrollment. That is, for women enrolled after October in either study cohort, the vaccine will be switched to the newly available vaccine for that year.

The control group will be placebo (saline injection). The justification for the use of a placebo injection in this trial is as follows: There is only one trial (Bangladesh) that demonstrates efficacy of influenza vaccination in pregnancy on perinatal outcomes and respiratory morbidity in early infancy. One of the issues with that study is that it was not placebo controlled. The "control" in that study was adult pneumococcal vaccine. It could be that the Bangladesh study underestimated the impact of influenza vaccine because the mothers and infants receive some indirect protection from the pneumococcal vaccine. In addition, influenza vaccine is not part of national policy or recommendations in Nepal at the current time and Ministry of Health officials are very interested in the results of our study as they consider their immunization program expansion over the next few years.

Conditions
Influenza Human
Being tested
influenza vaccine, saline placebo
Keywords
influenza, immunization, pregnancy, efficacy, pertussis, hepatitis E
Medical subject headings
Influenza, Human, Whooping Cough, Hepatitis E

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • influenza vaccineBiological

    Also called "VAXIGRIP®

    Pregnant women will receive FDA approved influenza vaccine.

  • saline placeboBiological

    Also called saline

    Vaccination of pregnant women with saline placebo.

Study groups in NCT01034254
Study groupRoleWhat they receive
influenza vaccineExperimentalPregnant women assigned to the intervention group will receive one dose of seasonal influenza vaccine at the time of enrollment. The vaccine that will be given will be the current seasonal influenza recommended vaccine at the time of enrollment.
Receives: Biological: influenza vaccine
saline placeboPlacebo comparatorPregnant women assigned to the control group will receive one dose of placebo (normal saline).
Receives: Biological: saline placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Field Trial of Maternal Influenza Immunization

    To compare, in women randomized to receive either influenza vaccine or control during pregnancy and their infants (through 6 months of age)

    1. the incidence of influenza-like illness or lab-confirmed influenza episodes b) the distribution of causes of febrile illness and the incidence of clinic visits and hospitalizations c) the incidence of low birth weight, the distribution of birth weight and gestational age and the growth of infants.

    Measured: 2 annual recruitment cycles coinciding with flu seasons

Secondary outcomes (4)

  1. Substudy #1: Transplacental Transfer of Influenza Antibody from Mother to Infant

    1. To estimate the efficacy of maternal vaccination for producing an immune response in the mother and for passive antibody transfer to the infant.
    2. To determine if timing of vaccination during pregnancy or other maternal factors such as nutritional status are related to level of antibody transfer to the infant.
    3. To compare neutralizing antibody concentrations in breastmilk of women randomized to receive either influenza vaccine or control during pregnancy.

    Measured: 2 annual recruitment cycles

  2. Substudy #2: Indirect Protection of Maternal Influenza Vaccination on Family Members

    Specific Aim: To compare the indirect protection of influenza vaccine on influenza-like and influenza-specific febrile illness rates in families of study women.

    Measured: 2 annual recruiting cycles

  3. Substudy #3: Hepatitis E Infection in Pregnancy

    1. To estimate the prevalence of anti-hepatitis E immunoglobulin G in women of reproductive age in rural Nepal.
    2. To estimate the incidence of hepatitis E infection (anti-hepatitis E seroconversion) during pregnancy in rural Nepal.
    3. To estimate the disease to infection ratio among women who seroconvert.
    4. To evaluate biochemical correlates of clinical disease among women who seroconvert.
    5. To describe pregnancy outcomes (miscarriage, stillbirth, neonatal mortality, maternal mortality) associated with women identified with incident infection or acute hepatitis E disease.

    Measured: 2 annual recruiting cycles

  4. Pertussis In Infants

    Estimate the incidence of pertussis in infants under 6 months of age and the protection afforded by maternal antibody transfer to infants.

    Measured: 2 annual rucruiting cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2009 (estimated)
  2. Study startNov 2010
  3. Primary completionMay 2014
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,693 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01034254
Sponsor's protocol ID
Mothers'Gift 241 Field Trial
Acronym
Mothers'Gift
Status last verified
Jan 2022
First submitted
16 Dec 2009
Last updated
1 Feb 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: To be determined

Publications

  • Cox S, Posner SF, McPheeters M, Jamieson DJ, Kourtis AP, Meikle S. Hospitalizations with respiratory illness among pregnant women during influenza season. Obstet Gynecol. 2006 Jun;107(6):1315-22. doi: 10.1097/01.AOG.0000218702.92005.bb.

    PubMed 16738158

  • Dodds L, McNeil SA, Fell DB, Allen VM, Coombs A, Scott J, MacDonald N. Impact of influenza exposure on rates of hospital admissions and physician visits because of respiratory illness among pregnant women. CMAJ. 2007 Feb 13;176(4):463-8. doi: 10.1503/cmaj.061435.

    PubMed 17296958

  • Englund JA. Maternal immunization with inactivated influenza vaccine: rationale and experience. Vaccine. 2003 Jul 28;21(24):3460-4. doi: 10.1016/s0264-410x(03)00351-7.

    PubMed 12850360

  • Greenwood B. Maternal immunisation in developing countries. Vaccine. 2003 Jul 28;21(24):3436-41. doi: 10.1016/s0264-410x(03)00346-3.

    PubMed 12850355

  • Healy CM, Baker CJ. Maternal immunization. Pediatr Infect Dis J. 2007 Oct;26(10):945-8. doi: 10.1097/INF.0b013e318156c18c. No abstract available.

    PubMed 17901801

  • Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.

    PubMed 15752534

  • Mak TK, Mangtani P, Leese J, Watson JM, Pfeifer D. Influenza vaccination in pregnancy: current evidence and selected national policies. Lancet Infect Dis. 2008 Jan;8(1):44-52. doi: 10.1016/S1473-3099(07)70311-0.

    PubMed 18156088

  • Zaman K, Roy E, Arifeen SE, Rahman M, Raqib R, Wilson E, Omer SB, Shahid NS, Breiman RF, Steinhoff MC. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med. 2008 Oct 9;359(15):1555-64. doi: 10.1056/NEJMoa0708630. Epub 2008 Sep 17.

    PubMed 18799552

  • MacDonald NE, Riley LE, Steinhoff MC. Influenza immunization in pregnancy. Obstet Gynecol. 2009 Aug;114(2 Pt 1):365-368. doi: 10.1097/AOG.0b013e3181af6ce8.

    PubMed 19622998

  • Tamma PD, Ault KA, del Rio C, Steinhoff MC, Halsey NA, Omer SB. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol. 2009 Dec;201(6):547-52. doi: 10.1016/j.ajog.2009.09.034. Epub 2009 Oct 21.

    PubMed 19850275

  • Pickering LK, Baker CJ, Freed GL, Gall SA, Grogg SE, Poland GA, Rodewald LE, Schaffner W, Stinchfield P, Tan L, Zimmerman RK, Orenstein WA; Infectious Diseases Society of America. Immunization programs for infants, children, adolescents, and adults: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Sep 15;49(6):817-40. doi: 10.1086/605430.

    PubMed 19659433

  • Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NS; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008. MMWR Recomm Rep. 2008 Aug 8;57(RR-7):1-60.

    PubMed 18685555

  • Regodon Wallin A, Tielsch JM, Khatry SK, Mullany LC, Englund JA, Chu H, LeClerq SC, Katz J. Nausea, vomiting and poor appetite during pregnancy and adverse birth outcomes in rural Nepal: an observational cohort study. BMC Pregnancy Childbirth. 2020 Sep 17;20(1):545. doi: 10.1186/s12884-020-03141-1.

    PubMed 32943001

  • 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.

    PubMed 32526188

  • 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.

    PubMed 32379201

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing influenza vaccine in people with Influenza Human, run by Children's Hospital Medical Center, Cincinnati at 1 site in Nepal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Field Trial of Maternal Influenza Immunization (time frame: 2 annual recruitment cycles coinciding with flu seasons). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01034254, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.

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