Virus DiseasesPhase 4NCT01842997
Safety of H1N1 Influenza Vaccination in Pregnant Women
A Phase 4 study testing split-virion, non-adjuvanted H1N1 vaccine of 15 μg in people with Virus Diseases and Respiratory Tract Infections, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
Since October 2009, H1N1 influenza vaccine has developed and approved of immunization in population in China. However, there was little epidemiological evidence of safety when vaccinated in healthy pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virus Diseases, Respiratory Tract Infections, Influenza
- What is being tested?
- split-virion, non-adjuvanted H1N1 vaccine of 15 μg
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- Oct 2009to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women
- Be able to show legal identity card for the sake of recruitment
- Be able to understand and sign the informed consent
Who cannot join
- Cases, cured cases and close contact of influenza A (H1N1) virus
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
- Diabetes mellitus (type I or II), with the exception of gestational diabetes
Show all 17Show fewer
- History of thyroidectomy or thyroid disease that required medication within the past 12 months
- Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
- History of any blood products or seasonal influenza vaccine administration within 3 months before the dosing
- Administration of any other investigational research agents within 30 days before the dosing
- Administration of any live attenuated vaccine within 30 days before the dosing
- Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
- Axillary temperature > 37.0 centigrade at the time of dosing
- Psychiatric condition that precludes compliance with the protocol
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangshui Center for Disease Control and Prevention
Xiangshui, Jiangsu, 224600
About this study
Official title: A Stratified and Controlled Clinical Trial With Split-virion, Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Pregnant Women
Since October 2009, H1N1 influenza vaccine has developed and approved of immunization in population in China. However, there was little epidemiological evidence of safety when vaccinated in healthy pregnant women. The main objective of this study is to assess the safety of split-virion inactivated H1N1 vaccine without adjuvant when administered in healthy pregnant women. It is a stratified and controlled clinical trial in healthy pregnant women. And participants were included up to 226 healthy pregnant women aged 18 -35 years old who have no history of novel influenza H1N1 infection or novel influenza H1N1 vaccination. The pregnancy week ranged from 5 weeks to 32 weeks. Subjects were divided into 2 groups: vaccinated group（122） and unvaccinated group（104）. Subjects in the vaccinated group were administered one dose of 15μg H1N1 vaccine. Subjects in the unvaccinated group received no vaccine as controls. Safety will be measured by assessment of pregnancy outcomes. And observation time for pregnancy outcomes was lasting for 28 days postpartum since vaccinated; and protective effect was observed for six months.
- Being tested
- split-virion, non-adjuvanted H1N1 vaccine of 15 μg
- Keywords
- Flu, non-adjuvanted H1N1 vaccine, Safety, pregnant women
- Medical subject headings
- Virus Diseases, Respiratory Tract Infections, Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
split-virion, non-adjuvanted H1N1 vaccine of 15 μgBiological
122 participants (19 at 5-9 weeks pregnant,36 at 10-19 weeks pregnant,13 at 20-29 weeks pregnant,54 at more than 30 weeks pregnant) received split-virion, non-adjuvanted H1N1 vaccine of 15 μg.
| Study group | Role | What they receive |
|---|---|---|
| split-virion, non-adjuvanted H1N1 vaccine of 15 μg | Experimental | split-virion, non-adjuvanted H1N1 vaccine of 15 μg made by Shanghai Institute of Biological Products lot number: 200909008 Receives: Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Pregnancy Outcomes
include the following indicators： incidence of spontaneous abortion, incidence of induced abortion，incidence of Preterm, incidence of post-term pregnancy, proportion of underweight-Babies
Measured: 0-28 days postpartum
Secondary outcomes (1)
incidence of influenza-like illness
Measured: 0-6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virus DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Principal investigator, fubaoma, Jiangsu Province Centers for Disease Control and Prevention
- Investigators
- Fubao Ma, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842997
- Sponsor's protocol ID
- JSEPI-001
- Status last verified
- Apr 2013
- First submitted
- 24 Apr 2013
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ma F, Zhang L, Jiang R, Zhang J, Wang H, Gao X, Li X, Liu Y. Prospective cohort study of the safety of an influenza A(H1N1) vaccine in pregnant Chinese women. Clin Vaccine Immunol. 2014 Sep;21(9):1282-7. doi: 10.1128/CVI.00375-14. Epub 2014 Jul 2.
PubMed 24990911
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stratified and Controlled Clinical Trial With Split-virion, Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Pregnant Women
- ClinicalTrials.gov ID
- NCT01842997
- Acronym / sponsor ID
- JSEPI-001
- Keywords
- Flu, non-adjuvanted H1N1 vaccine, Safety, pregnant women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since October 2009, H1N1 influenza vaccine has developed and approved of immunization in population in China. However, there was little epidemiological evidence of safety when vaccinated in healthy pregnant women. The main objective of this study is to assess the safety of split-virion inactivated H1N1 vaccine without adjuvant when administered in healthy pregnant women. It is a stratified and controlled clinical trial in healthy pregnant women. And participants were included up to 226 healthy pregnant women aged 18 -35 years old who have no history of novel influenza H1N1 infection or novel influenza H1N1 vaccination. The pregnancy week ranged from 5 weeks to 32 weeks. Subjects were divided into 2 groups: vaccinated group（122） and unvaccinated group（104）. Subjects in the vaccinated group were administered one dose of 15μg H1N1 vaccine. Subjects in the unvaccinated group received no vaccine as controls. Safety will be measured by assessment of pregnancy outcomes. And observation time for pregnancy outcomes was lasting for 28 days postpartum since vaccinated; and protective effect was observed for six months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| split-virion, non-adjuvanted H1N1 vaccine of 15 μg | Experimental | Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μgsplit-virion, non-adjuvanted H1N1 vaccine of 15 μg made by Shanghai Institute of Biological Products lot number: 200909008 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy pregnant women
- Be able to show legal identity card for the sake of recruitment
- Be able to understand and sign the informed consent
Key exclusion criteria (17 listed)
- Cases, cured cases and close contact of influenza A (H1N1) virus
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| split-virion, non-adjuvanted H1N1 vaccine of 15 μg122 participants (19 at 5-9 weeks pregnant,36 at 10-19 weeks pregnant,13 at 20-29 weeks pregnant,54 at more than 30 weeks pregnant) received split-virion, non-adjuvanted H1N1 vaccine of 15 μg. | Biological | split-virion, non-adjuvanted H1N1 vaccine of 15 μg |
Primary outcome
Adverse Pregnancy Outcomes
Time frame: 0-28 days postpartum
include the following indicators： incidence of spontaneous abortion, incidence of induced abortion，incidence of Preterm, incidence of post-term pregnancy, proportion of underweight-Babies
1 secondary outcome
incidence of influenza-like illness
Time frame: 0-6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
- Derived from this study: PubMed 24990911Ma F, Zhang L, Jiang R, Zhang J, Wang H, Gao X, Li X, Liu Y. Prospective cohort study of the safety of an influenza A(H1N1) vaccine in pregnant Chinese women. Clin Vaccine Immunol. 2014 Sep;21(9):1282-7. doi: 10.1128/CVI.00375-14. Epub 2014 Jul 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fubao Ma principal investigator
Jiangsu Province Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing split-virion, non-adjuvanted H1N1 vaccine of 15 μg in people with Virus Diseases and Respiratory Tract Infections, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Pregnancy Outcomes (time frame: 0-28 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01842997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.