Phase 2
N=102
Influenza Vaccine in Pregnant Women
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00905125 ↗Enrolled (actual)
102
Serious AEs
20.6%
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2008-2009 Seasonal Inactivated Trivalent Influenza Vaccine (TIV) — 4; 3; 35; 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluzone® (Biological); Fluarix® (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2008-2009 Seasonal Inactivated Trivalent Influenza Vaccine (TIV) |
4; 3; 35; 33; 7; 7 | — |
| PRIMARY Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery. |
1; 1; 1; 0; 2; 4 | — |
| PRIMARY Number of Participants Reporting Neonatal Complications. |
3; 4; 4; 9; 3; 2 | — |
| PRIMARY Number of Participants Reporting Serious Adverse Events (SAE) |
8; 13 | — |
| PRIMARY Number of Participants Reporting Unsolicited Non-serious Adverse Events Considered Associated With Vaccination |
0; 3 | — |
| PRIMARY Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale |
14; 22; 4; 1; 0; 0 | — |
| PRIMARY Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness at Each Grade |
2; 3; 2; 1; 0; 0 | — |
| PRIMARY Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale |
5; 2; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Reporting Fever Based on the Protocol-defined Grading Scale for Oral Temperature |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine |
10.8; 10.0; 67.5; 41.7; 11.7; 10.9 | — |
| PRIMARY Number of Participants With a Four-fold or Greater Rise in HAI Antibody Titer Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine |
25; 24; 35; 39; 35; 40 | — |
| SECONDARY Number of Participants With a Serum Microneutralization Antibody Titer of Greater Than or Equal to 40 Against Each Antigen in the 2008-2009 TIV |
— | — |
| SECONDARY Number of Participants With a Four-fold or Greater Rise in Microneutralization Antibody Titer Against Each Antigen in the 2008-2009 TIV |
— | — |
| SECONDARY Microneutralization Assay Geometric Mean Antibody Titers Against Each Antigen in the 2008-2009 TIV |
— | — |
Summary
In pregnant women, flu may cause complications like pneumonia (infection of the lungs) or hospitalization. In the United States (US) it is recommend that all women get flu vaccine if they are going to be pregnant or deliver during the flu season but only a few studies have measured a pregnant woman's immune response (the body's defense against the flu) after getting the flu vaccine. About 200, 18-39 year old, inclusive, pregnant women in their second or third trimester (from 14 weeks of gestation to term, inclusive) will be enrolled in this US based study. Participation will be about 8 months in duration. Women will be randomized (assigned by chance) to receive either Fluzone® or Fluarix®. Blood collection will occur on Day 0 and 28 days post vaccination.
Eligibility Criteria
Inclusion Criteria
- Pregnant female between the ages of 18 and 39 years, inclusive.
- Is from 14 weeks of gestation to term, inclusive.
- Is in good health, as determined by vital signs (heart rate 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed) or has received steroids for treatment of pre-term labor during this pregnancy.
- Has a history of receiving immunoglobulin or other blood product (with exception of Rhogam) within the 3 months prior to vaccination in this study.
- Has a diagnosis of a current and uncontrolled major psychiatric disorder.
- The subject is receiving listed psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving an antidepressant drug and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study.
- Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- History of alcohol or drug abuse in the 1 year prior to enrollment.
- Has a history of Guillain-Barré syndrome.
- Has a seizure disorder or is on an anti-seizure medication for a seizure disorder.
- Has received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) during this pregnancy prior to enrollment, or expects to receive an experimental/investigational agent prior to Visit 4 (Day 28 visit).
- Has an acute or chronic medical condition that, in the opinion of the investigator would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, transplant recipients, uncontrolled diabetes, juvenile diabetes (Type 1) or advanced diabetes with renal and eye disease; diabetes controlled by diet or oral agents is acceptable).
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Data sourced from ClinicalTrials.gov (NCT00905125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.