A Phase II/III clinical Study to Evaluate the Immunogenicity and Safety of Three Formulations of Monovalent H1N1 Influenza A (2009) Virus Vaccine, Manufactured by Panacea Biotec Ltd., in Healthy Pediatric Population 3-9 years of Age.
- Registration Number
- CTRI/2010/091/000031
- Lead Sponsor
- Panacea Biotec Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 360
1.Subjects aged 3- 9 years whose parents/LAR gives a written informed consent prior to the study entry.
2.Subjects with good health as determined by:
- Medical history
- Physical examination
- Clinical judgment of the investigator
1.The parents or LAR are unwilling or unable to give written informed consent to participate in the study.
2.The subject (7- 9 years) who does not assent to participate in the study.
3.The subject is a case, cured case or has a history of close contact with influenza A (H1N1) virus infected patients.
4.Subject having history of previous immunization with any pandemic or seasonal influenzae vaccine.
5.Subject with history of systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
6.Has received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study, or plan receipt of such vaccines within 21 days following the second vaccination. The initiation of this protocol does not take precedence over routine immunizations.
7. Has a history of severe reactions following previous immunization with influenza virus vaccines
8.Subject allergic to egg or egg protein.
9.Subjects who are taking any antiviral drug either for treatment or prophylaxis against infection.
10.Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
11.Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)
12.Have an active neoplastic disease or a history of any hematologic malignancy.
13.Axillary temperature > 37.0 centigrade in past 3 days.
14.Presence or past history of significant cardiovascular, hepatic, renal, pulmonary (including respiratory depression or diseases involving obstruction/ narrowing of airways), gastrointestinal, endocrine (including past history of thyroidectomy or thyroid disease, Diabetes mellitus), dermatological, neurological (including encephalopathy, seizure/epilepsy history and/or taking anti-seizure medication etc.) or psychiatric disease or disorder or autoimmune disease that in the opinion of the investigator, places the participant at an unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or interfere with the successful completion of the study..
15.Any history suggestive of thrombocytopenia or a bleeding disorder.
16.Subjects with Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
17.Subjects with history of Guillain-Barre Syndrome
18.Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 7 days.
19.Subjects who have received any blood transfusion, immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
20.Self-reported seropositivity for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection or autoimmune hepatitis.
21.Family members of the employees of the study centre or the Investigator.
22.Receipt of any allergy shots and/or seasonal allergy medication in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots and/or seasonal allergy medication in the 7-day period after enrollment (vaccination)
23.Subjects who have participated in another trial of an investigational agent within 30 days of enr
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunological Endpoint <br/ ><br>In each Group and at each sampling timepoint <br/ ><br>-The proportion of subjects with hemagglutination inhibition (HI) antibody titers ≥1:40. <br/ ><br>-Seroconversion rate: the proportion of subjects with a 4-fold rise in HI titer (pre HI 1:10, post ≥1:40, pre HI ≥1:10, post ≥4x pre). <br/ ><br>-Geometric Mean Titres (GMT) <br/ ><br>Timepoint: 21 days after each vaccination
- Secondary Outcome Measures
Name Time Method Safety Endpoint <br/ ><br>-Incidence of solicited local and systemic events within 7 days of each vaccine dose. <br/ ><br>-Incidence of unsolicited adverse events upto 42 days after last vaccination. <br/ ><br>-Incidence of serious adverse events (SAEs) during the entire study period <br/ ><br>Timepoint: Upto 42 days after last vaccination