H1N1 Vaccine in Pregnant Women
This study has been completed.
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00963430
First received: August 20, 2009
Last updated: November 29, 2012
Last verified: April 2010
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Results First Received: April 21, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
| Condition: |
Influenza |
| Intervention: |
Biological: Inactivated H1N1 Vaccine |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Participants were healthy pregnant women recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 09Sep2009 and 16Oct2009. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 15 Mcg H1N1 Vaccine | Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21. |
| 30 Mcg H1N1 Vaccine | Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21. |
Participant Flow: Overall Study
| 15 Mcg H1N1 Vaccine | 30 Mcg H1N1 Vaccine | |
|---|---|---|
| STARTED | 60 | 60 |
| COMPLETED | 59 | 57 |
| NOT COMPLETED | 1 | 3 |
Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 15 Mcg H1N1 Vaccine | Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21. |
| 30 Mcg H1N1 Vaccine | Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21. |
| Total | Total of all reporting groups |
Baseline Measures
| 15 Mcg H1N1 Vaccine | 30 Mcg H1N1 Vaccine | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
60 | 60 | 120 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 60 | 60 | 120 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: years] Mean (Standard Deviation) |
31.7 (4.3) | 31.2 (4.3) | 31.4 (4.3) |
|
Gender
[units: participants] |
|||
| Female | 60 | 60 | 120 |
| Male | 0 | 0 | 0 |
|
Region of Enrollment
[units: participants] |
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| United States | 60 | 60 | 120 |
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination [ Time Frame: Within 8 days (Day 0-7) post first vaccination ] |
| 2. Primary: | Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination [ Time Frame: Within 8 days (Day 0-7) post second vaccination ] |
| 3. Primary: | Number of Participants Reporting Solicited Quantitative Local Reactions After First Vaccination [ Time Frame: Within 8 days (Day 0-7) post first vaccination ] |
| 4. Primary: | Number of Participants Reporting Solicited Quantitative Local Reactions After Second Vaccination [ Time Frame: Within 8 days (Day 0-7) post second vaccination ] |
| 5. Primary: | Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination [ Time Frame: Within 8 days (Day 0-7) post first vaccination ] |
| 6. Primary: | Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination [ Time Frame: Within 8 days (Day 0-7) post second vaccination ] |
| 7. Primary: | Number of Participants Reporting Fever After First Vaccination [ Time Frame: Within 8 days (Day 0-7) post first vaccination ] |
| 8. Primary: | Number of Participants Reporting Fever After Second Vaccination [ Time Frame: Within 8 days (Day 0-7) post second vaccination ] |
| 9. Primary: | Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Day 21 after the first vaccination ] |
| 10. Primary: | Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 21 after the first vaccination ] |
| 11. Primary: | Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery [ Time Frame: At time of delivery ] |
| 12. Primary: | Number of Participants Reporting Neonatal Complications [ Time Frame: At time of delivery ] |
| 13. Primary: | Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) [ Time Frame: Day 0 through Day 180 after last vaccination ] |
| 14. Secondary: | Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery [ Time Frame: At time of delivery ] |
| 15. Secondary: | Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood [ Time Frame: At time of delivery ] |
| 16. Secondary: | Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ] |
Hide Outcome Measure 16
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine |
| Measure Description | Blood was collected from all participants prior to the initial vaccination as well as 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more. |
| Time Frame | Day 0 prior to first vaccination and Day 21 after the second vaccination |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Participants were included in the analyses if they received both vaccinations within 4 days of the window and had blood collected at both timepoints, with 13 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated. |
Reporting Groups
| Description | |
|---|---|
| 15 Mcg H1N1 Vaccine | Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21. |
| 30 Mcg H1N1 Vaccine | Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21. |
Measured Values
| 15 Mcg H1N1 Vaccine | 30 Mcg H1N1 Vaccine | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
38 | 51 |
|
Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine
[units: Participants] |
36 | 47 |
No statistical analysis provided for Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine
| 17. Secondary: | Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine [ Time Frame: Day 21 after the second vaccination ] |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |