H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A H1N1v Vaccination in Pregnant Women
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01012557 |
Recruitment Status :
Completed
First Posted : November 13, 2009
Last Update Posted : February 5, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
H1N1v Influenza | Biological: Focetria | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 296 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza AH1N1v Vaccination in Pregnant Women |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Pregnant women (>20 weeks), 7.5 mcg H1N1v full MF59 adjuvant |
Biological: Focetria
7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular)x 1 |
Active Comparator: Pregnant women (>20 weeks), 3.75 mcg H1N1v half MF59 adjuvant |
Biological: Focetria
3.75 mcg H1N1v half MF59 adjuvant i.m.(intramuscular)x 1 |
Active Comparator: Pregnant women (>20 weeks), 15 mcg H1N1v unadjuvanted |
Biological: Focetria
15 mcg N1N1v unadjuvanted i.m.(intramuscular) x 1. |
Active Comparator: Non-pregnant mothers, 7.5 mcg H1N1v full MF59 adjuvant |
Biological: Focetria
7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular) x 1 |
- Day 22/Day 1, and at all the other relevant time points to assess persistence/Day 1 geometric mean ratio (GMR) of HI [ Time Frame: Day 1, Day 22 ]
- Geometric mean HI titer (GMT) on Day 1, Day 22, and at all the other relevant time points to assess persistence. [ Time Frame: Day 1, Day 22 ]
- Percentage of subjects achieving a seroconversion or a significant increase (defined as: HI ≥1:40 for subjects negative at baseline [<1:10]; a minimum 4-fold increase in HI titer for subjects positive at baseline [HI≥1:10]) [ Time Frame: Day 1, Day 22 ]
- Percentage of subjects with a HI titer ≥1:40 (i.e. seroprotection) on Day 1, Day 22, and at all the other relevant time points to assess persistence [ Time Frame: Day 1, Day 22 ]
- The safety of the study vaccines will be assessed based on number of subjects exposed to study vaccines with reported selected adverse events per vaccine group. [ Time Frame: 12 months ]
- The outcomes of pregnancies will be categorized as normal, abnormal or therapeutic/elective termination [ Time Frame: duration of pregnancy ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy pregnant and non pregnant women living in Eastern Denmark
- Fluent in Danish
Exclusion Criteria:
- Heart disease, endocrine disease, tuberculosis and sarcoidosis.
- History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), and chicken proteins.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012557
Denmark | |
COPSAC | |
Gentofte/Copenhagen, Denmark, 2620 | |
Næstved Hospital, Pediatric Department | |
Næstved, Denmark, 4700 |
Other Publications:
Responsible Party: | Copenhagen Studies on Asthma in Childhood |
ClinicalTrials.gov Identifier: | NCT01012557 |
Other Study ID Numbers: |
H1N1v |
First Posted: | November 13, 2009 Key Record Dates |
Last Update Posted: | February 5, 2015 |
Last Verified: | February 2015 |
H1N1v vaccine pregnant women Assess whether the adjuvanted vaccine offers a meaningful benefit in pregnant women in terms of immune response over the non-adjuvanted vaccine. |
Assess the persistence of immune response over a 15 month time period after one single vaccination of the pregnant mother. Assess whether the immune response to H1N1 in pregnant women is different from that of non-pregnant women of similar age. Gain insight on safety of the Novartis egg-based MF59 adjuvanted H1N1 vaccine Focetria in pregnant women and their babies. Assess the maternally transferred specific antibodies against H1N1v in the newborn Passive immunity transferred to the infant. |
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Diseases |