Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01181323 · ClinicalTrials.gov registry record · Phase 2
Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
NCT01181323: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01181323 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 240 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01181323, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
Study Summary
The purpose of this research study is to learn more about the safety of 2 licensed flu vaccines, nasal spray and flu vaccine shot, in mothers and their infants, when given to women who are breastfeeding and to compare the immune response (body's defense against foreign substances) of breastfeeding mothers, who receive intranasal flu vaccine, with breastfeeding mothers receiving the flu vaccine shot. Healthy women (240 volunteers, 28-120 days post delivery) who plan to breastfeed through 28 days post vaccination and who have not received influenza vaccine for the influenza season for which they are being enrolled, will be assigned by chance to 1 of the 2 vaccines in the following manner: flu vaccine nasal spray and a placebo (inactive substance) shot or a flu vaccine shot and a placebo nasal spray. Study procedures include: nasal swabs, blood samples, and completion of memory aids. Participants will be involved in this United States based study for about 6 months.
Primary Outcome
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes, regardless of relationship to study product or study participation.
Interventions
- OTHER Placebo
- BIOLOGICAL Trivalent inactivated influenza vaccine
- BIOLOGICAL Cold-adapted live attenuated influenza virus vaccine, trivalent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT01181323 record still lists
NCT01181323 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01181323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01181323 about?
NCT01181323 is a clinical study titled "Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women". The purpose of this research study is to learn more about the safety of 2 licensed flu vaccines, nasal spray and flu vaccine shot, in mothers and their infants, when given to women who are breastfeeding and to compare the immune response (body's defense against foreign substances) of breastfeeding m...
What is the current status of trial NCT01181323?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2011-09. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01181323?
The interventions under investigation include: Placebo (OTHER), Trivalent inactivated influenza vaccine (BIOLOGICAL), Cold-adapted live attenuated influenza virus vaccine, trivalent (BIOLOGICAL).
Who is sponsoring clinical trial NCT01181323?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01181323's enrollment target sits among peer trials
240 239th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02855554 · 240 participants · NA
Quantitative Cardiac Parametric Mapping
- NCT03230565 · 240 participants · Phase 4
Continuous Infusions vs Scheduled Bolus Infusions
- NCT03399929 · 240 participants
Traumatic Brain Injury and Stroke Long Term Outcome
- NCT03583710 · 240 participants · Phase 3
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia