NCT01037829

Brief Summary

The primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at investigative sites within the Netherlands, Italy, and Argentina.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,529

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
3 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

10 months

First QC Date

December 21, 2009

Last Update Submit

September 28, 2011

Conditions

Influenza

Outcome Measures

Primary Outcomes (6)

  • Normal live-born delivery

    3 months follow-up on all live births

  • Spontaneous and elective abortions

    3 months follow-up on all live births

  • Congenital malformations

    3 months follow-up on all live births

  • Pre-term birth (prematurity)

    3 months follow-up on all live births

  • Low birth weight

    3 months follow-up on all live births

  • Neonatal mortality

    3 months follow-up on all live births

Secondary Outcomes (1)

  • Maternal complications of gestational diabetes, preeclampsia, maternal death

    During pregnancy and post delivery

Study Arms (1)

Pregnancy women

Comparison of pregnancy outcomes between (Novartis) H1N1 vaccinated women and (Novartis) H1N1 unvaccinated women.

Other: Non-intervention observational study

Interventions

Non-intervention observational studyOTHER

Non-intervention observational study

Pregnancy women

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women

You may qualify if:

  • Currently pregnant OR was pregnant following the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest and have already experienced a pregnancy outcome
  • Consents to participate in the study

You may not qualify if:

  • Is not currently pregnant OR was not pregnant at the time of or after the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest
  • Does not consent to participate in the study
  • Has received a non-Novartis pandemic influenza vaccinee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Buenos Aires, 1706, Argentina

Location

Unknown Facility

Córdoba, X5000, Argentina

Location

Unknown Facility

Villa Nueva, 5519, Argentina

Location

Unknown Facility

Bari, 79124, Italy

Location

Unknown Facility

Cagliari, 09126, Italy

Location

Unknown Facility

Como, 22100, Italy

Location

Unknown Facility

Milan, 20126, Italy

Location

Unknown Facility

Milan, 20157, Italy

Location

Unknown Facility

Monza, 20052, Italy

Location

Unknown Facility

Prato, 59100, Italy

Location

Unknown Facility

Roma, 00135, Italy

Location

Unknown Facility

Rome, 00168, Italy

Location

Unknown Facility

Siena, 53100, Italy

Location

Unknown Facility

Trieste, 34100, Italy

Location

Unknown Facility

Udine, 33100, Italy

Location

Unknown Facility

Vicenza, 36100, Italy

Location

Podiumweg

Ilsselstein, Netherlands

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2009

First Posted

December 23, 2009

Study Start

January 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

AR(3)IT(13)NL(1)